EB-1170K; EB-1570K; EB-1575K; EB=1970K; EB-1970TK; EB-1975K

Ear, Nose, and Throat Devices

2

No

Nationwide Distribution

Pentax Video Bronchoscope || Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

EB-1970UK

Ear, Nose, and Throat Devices

2

No

Nationwide Distribution

Ultrasound Video Bronchoscope || The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Lot #202085 Stryker Product Number: 6001-420-000

Ear, Nose, and Throat Devices

2

No

US (nationwide) Distribution to the states of : CA, CT, GA, IL, IN, MA, MD, NC, OH, PA, TN, and TX.

Stryker PROFESS Registration Kit. || The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system is comprised of PROFESS Registration Stickers, a PROFESS Patient Tracker, and a PROFESS Adaptor Cable.

Model #'s: EB-1170K, EB-1570, EB-1570AK, EB-1570K, EB-1970AK, EB-1970K, EB-1970TK and EB-1970UK

Ear, Nose, and Throat Devices

2

No

US Nationwide and Internationally

Video Bronchoscope

Model #'s:ECY-1570 and ECY-1570K

Ear, Nose, and Throat Devices

2

No

US Nationwide and Internationally

Video Cytoscopes

Model #: VNL-1570STK

Ear, Nose, and Throat Devices

2

No

US Nationwide and Internationally

Video Naso pharyngo Laryngoscopes

Lot numbers 17022809, 17030108,17022207,17022106, 17020805, 17020904, 17021798,17020987, 17011896, 17011221, 17011220, 16122237, 16122236, 16121661,16121260, 16121259, and 16112958

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to Canada.

Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

Lot numbers 17030722, 17022421,17022020, 17020619, 17011918, 17012417, I 17010602, 16122724,16122239, 16122038, 16120563, and 16112362

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to Canada.

Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

Lot numbers 17030728, 17022027, 17021426, 17013125, 17012724, 17011303, 16122767, 16122066, 16112965, and 16112164

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to Canada.

Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

Lot numbers 17022451,17011750, 16120349, 16082989, 16081888, 16071987, 16062713, and 16060712

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to Canada.

Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

Each of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory. The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf. Therefore, no kit lot number is being provided.

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to Canada.

Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

Each of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory. The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf. Therefore, no kit lot number is being provided.

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to Canada.

Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

Each of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory. The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf. Therefore, no kit lot number is being provided.

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to Canada.

Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

Each of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory. The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf. Therefore, no kit lot number is being provided.To be provided

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution - US (nationwide) and Internationally to Canada.

Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

Product order numbers 010038, 010049, 010050, 010065, 010067, 010073, 010085, 030534, 040664, 040700, 040703, 040847, DM010038, DM010039, DM010049, DM010067, DM010074, LN030534. Serial numbers include P3 0547-P3 3404.

Ear, Nose, and Throat Devices

2

No

Product was distributed worldwide, to distributors in Canada, Australia/New Zealand, Japan, the European Union, Bahamas, Bermuda, Chile, China, Hong Kong, INdia, Indonesia, Israel, Italy, Kuwait, Luxembourg, Malaysia, Nigeria, Quatar, Romania, Saudi Aabia, Singapore, Slovakia, South Africa, South Korea, Sweden, Switzerland, Taiwan and Thailand.

Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing Screener.)

Lots 7669915, 7731928, 7809849 and 7580900.

Ear, Nose, and Throat Devices

2

No

Nationwide, Aruba, Australia, Belize, Bolivia, Bulgaria, Chile, China, Dominican Republic, Ecuador, Guatemala, Haiti, Honduras, Hong Kong, India, Indonesia, Israel, Jamaica, Jordan, Korea, Kuwait, Lebanon, Malaysia, Moldavia, New Zealand, Nicaragua, Oman, Pakistan, Panama, Paraguay, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Trinidad, Tobago, and Venezuela.

Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 220 cm, package of 10 brushes; Catalog No. 1640, Order No. M00516401.

Lots 7579586, 7605110, 7606870, 7606871, 7630518, 7630517, 7628255, 7650452, 7646613, 7664540, 7664221, 7661326, 7668106, 7713491, 7697308, 7701032, 7697695, 7731922, 7730456, 7713492, 7731923, 7750676, 7750675, 7750674, 7766684, 7766527, 7790329, 7769605, 7798015, 7799940, 7807535, 7809850, 7825637, 7825638, 7828001, 7854861, 7853825, 7856736, 7860774, 7874570, 7880712, 7899057, 7898228, 7886786, 7933144, 7929889, 7923394, 7924985 and 7949015.

Ear, Nose, and Throat Devices

2

No

Nationwide, Aruba, Australia, Belize, Bolivia, Bulgaria, Chile, China, Dominican Republic, Ecuador, Guatemala, Haiti, Honduras, Hong Kong, India, Indonesia, Israel, Jamaica, Jordan, Korea, Kuwait, Lebanon, Malaysia, Moldavia, New Zealand, Nicaragua, Oman, Pakistan, Panama, Paraguay, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, Trinidad, Tobago, and Venezuela.

Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 90 cm, package of 10 brushes; Catalog No. 1650, Order No M00516501.

All Serial Numbers.

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution

Anspach BlackMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.

1) EB-1570K   G110999 A110254 I A110067  G110338  G110522  G111115 A110125 A110019  A110277  G110538  G111192  G111270 G111216   G111254 G110973 A110022 G111250  2) EB-1970K A110151

Ear, Nose, and Throat Devices

2

No

Nationwide Distribution.

EB- Series Video Bronchoscopes, EB-1570K & EB-1970K. || Intended to provide optical visualization of (via a video monitor), and therapeutic access to, the Pulmonary Tract.

EE-1580K A110273

Ear, Nose, and Throat Devices

2

No

Nationwide Distribution.

EE- Series Video Esophagoscopes, EE-1580K. || Intended to provide optical visualization of (via a video monitor) and therapeutic access to, the Upper Gastrointestinal Track.

VNL-1570STK G110140

Ear, Nose, and Throat Devices

2

No

Nationwide Distribution.

EE- Series Video Naso Pharyngo Laryngo Scope, VNL-1570STK. || Intended to provide optical visualization (via a video monitor) of the Upper Airway.

Serial Number G11307654403

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution: US (nationwide) including Puerto Rico and states of: AL, AR, AZ, CA, CO, CT, DC, DE, GA, FL, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VE, VT, WA, WI, WY, and WV. Internationally to: AT, AU, BR, BS, CA, CH, CL, CO, CZ, CR, DE, DK, DO, EG, ES, FI, FR, GB, GR, HK, HU, ID, IL, IN, IS, JP, KH, KR, LB, LT, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, SA, SG, SY, TH, TR, TW, and ZA.

***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. || Intended for cutting and shaping bone.

Serial Number MM900

Ear, Nose, and Throat Devices

2

No

Worldwide Distribution: US (nationwide) including Puerto Rico and states of: AL, AR, AZ, CA, CO, CT, DC, DE, GA, FL, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VE, VT, WA, WI, WY, and WV. Internationally to: AT, AU, BR, BS, CA, CH, CL, CO, CZ, CR, DE, DK, DO, EG, ES, FI, FR, GB, GR, HK, HU, ID, IL, IN, IS, JP, KH, KR, LB, LT, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, SA, SG, SY, TH, TR, TW, and ZA.

***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. || Intended for cutting and shaping bone.

Lot Number: LFG-111813-1; Expiry date: June 2014; LFG020614-01, Expiry date: September 2014.

Ear, Nose, and Throat Devices

2

No

Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA.

PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.

Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008

Ear, Nose, and Throat Devices

2

No

Nationwide Distribution.

Cochlear Baha Soft tissue gauge 6mm. || Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.