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    Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines.

    FDA Enforcement
    Class II ·Terminated·A M Systems Inc·October 24, 2018

    Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 7, 2014

    Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015

    Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015

    ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 29, 2014

    Product 42 consists of all product under product code: HSB and same usage: Item no: 225224010 M/DN FEM IM NAIL 10MM DIA 225228010 M/DN FEM IM NAIL 10MM DIA 225230010 M/DN FEM IM NAIL 10MM DIA 225232010 M/DN FEM IM NAIL 10MM DIA 225234010 M/DN FEM IM NAIL 10MM DIA 225236010 M/DN FEM IM NAIL 10MM DIA 225238010 M/DN FEM IM NAIL 10MM DIA 225240010 M/DN FEM IM NAIL 10MM DIA 225242010 M/DN FEM IM NAIL 10MM DIA 225244010 M/DN FEM IM NAIL 10MM DIA 225246010 M/DN FEM IM NAIL 10MM DIA 225228011 M/DN FEM IM NAIL 11MM DIA 225230011 M/DN FEM IM NAIL 11MM DIA 225232011 M/DN FEM IM NAIL 11MM DIA 225234011 M/DN FEM IM NAIL 11MM DIA 225236011 M/DN FEM IM NAIL 11MM DIA 225238011 M/DN FEM IM NAIL 11MM DIA 225240011 M/DN FEM IM NAIL 11MM DIA 225242011 M/DN FEM IM NAIL 11MM DIA 225244011 M/DN FEM IM NAIL 11MM DIA 225246011 M/DN FEM IM NAIL 11MM DIA 225224012 M/DN FEM IM NAIL 12MM DIA 225232012 M/DN FEM IM NAIL 12MM DIA 225234012 M/DN FEM IM NAIL 12MM DIA 225236012 M/DN FEM IM NAIL 12MM DIA 225238012 M/DN FEM IM NAIL 12MM DIA 225240012 M/DN FEM IM NAIL 12MM DIA 225242012 M/DN FEM IM NAIL 12MM DIA 225244012 M/DN FEM IM NAIL 12MM DIA 225246012 M/DN FEM IM NAIL 12MM DIA 225228013 M/DN FEM IM NAIL 13MM DIA 225230013 M/DN FEM IM NAIL 13MM DIA 225232013 M/DN FEM IM NAIL 13MM DIA 225234013 M/DN FEM IM NAIL 13MM DIA 225236013 M/DN FEM IM NAIL 13MM DIA 225238013 M/DN FEM IM NAIL 13MM DIA 225240013 M/DN FEM IM NAIL 13MM DIA 225242013 M/DN FEM IM NAIL 13MM DIA 225244013 M/DN FEM IM NAIL 13MM DIA 225246013 M/DN FEM IM NAIL 13MM DIA 225236014 M/DN FEM IM NAIL 14MM DIA 225238014 M/DN FEM IM NAIL 14MM DIA 225240014 M/DN FEM IM NAIL 14MM DIA 225242014 M/DN FEM IM NAIL 14MM DIA 225244014 M/DN FEM IM NAIL 14MM DIA 225246014 M/DN FEM IM NAIL 14MM DIA 225234015 M/DN FEM IM NAIL 15MM DIA 225240015 M/DN FEM IM NAIL 15MM DIA 225242015 M/DN FEM IM NAIL 15MM DIA 225244015 M/DN FEM IM NAIL 15MM DIA 225242016 M/DN FEM IM NAIL 16MM DIA 225230008 M/DN FEM IM NAIL 8MM DIA 225232008 M/DN FEM IM NAIL 8MM DIA 225234008 M/DN FEM IM NAIL 8MM DIA 225238008 M/DN FEM IM NAIL 8MM DIA 225228009 M/DN FEM IM NAIL 9MM DIA 225230009 M/DN FEM IM NAIL 9MM DIA 225232009 M/DN FEM IM NAIL 9MM DIA 225234009 M/DN FEM IM NAIL 9MM DIA 225236009 M/DN FEM IM NAIL 9MM DIA 225238009 M/DN FEM IM NAIL 9MM DIA 225240009 M/DN FEM IM NAIL 9MM DIA 225242009 M/DN FEM IM NAIL 9MM DIA 225244009 M/DN FEM IM NAIL 9MM DIA 225418010 M/DN HUMERAL I/M NAIL 10M 225419510 M/DN HUMERAL I/M NAIL 10M 225421010 M/DN HUMERAL I/M NAIL 10M 225422510 M/DN HUMERAL I/M NAIL 10M 225424010 M/DN HUMERAL I/M NAIL 10M 225425510 M/DN HUMERAL I/M NAIL 10M 225427010 M/DN HUMERAL I/M NAIL 10M 225428510 M/DN HUMERAL I/M NAIL 10M 225430010 M/DN HUMERAL I/M NAIL 10M 225419511 M/DN HUMERAL I/M NAIL 11M 225421011 M/DN HUMERAL I/M NAIL 11M 225422511 M/DN HUMERAL I/M NAIL 11M 225424011 M/DN HUMERAL I/M NAIL 11M 225425511 M/DN HUMERAL I/M NAIL 11M 225427011 M/DN HUMERAL I/M NAIL 11M 225421012 M/DN HUMERAL I/M NAIL 12M 225422512 M/DN HUMERAL I/M NAIL 12M 225424012 M/DN HUMERAL I/M NAIL 12M 225425512 M/DN HUMERAL I/M NAIL 12M 225427012 M/DN HUMERAL I/M NAIL 12M 225428512 M/DN HUMERAL I/M NAIL 12M 225430012 M/DN HUMERAL I/M NAIL 12M 225418013 M/DN HUMERAL I/M NAIL 13M 225424013 M/DN HUMERAL I/M NAIL 13M 225427013 M/DN HUMERAL I/M NAIL 13M 225418006 M/DN HUMERAL I/M NAIL 6MM 225419506 M/DN HUMERAL I/M NAIL 6MM 225421006 M/DN HUMERAL I/M NAIL 6MM 225424006 M/DN HUMERAL I/M NAIL 6MM 225427006 M/DN HUMERAL I/M NAIL 6MM 225428506 M/DN HUMERAL I/M NAIL 6MM 225430006 M/DN HUMERAL I/M NAIL 6MM 225418007 M/DN HUMERAL I/M NAIL 7MM 225419507 M/DN HUMERAL I/M NAIL 7MM 225421007 M/DN HUMERAL I/M NAIL 7MM 225422507 M/DN HUMERAL I/M NAIL 7MM 225424007 M/DN HUMERAL I/M NAIL 7MM 225425507 M/DN HUMERAL I/M NAIL 7MM 225427007 M/DN HUMERAL I/M NAIL 7MM 225428507 M/DN HUMERAL I/M NAIL 7MM 225430007 M/DN HUMERAL I/M NAIL 7MM 225418008 M/DN HUMERAL I/M NAIL 8MM 225

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32CM TIBIAL I/M NAIL 14MMDX34CM TIBIAL I/M NAIL 15MMDX34CM TIBIAL I/M NAIL 14MMDX36CM TIBIAL I/M NAIL 15MMDX36CM TIBIAL I/M NAIL 14MMDX38CM TIBIAL I/M NAIL 15MMDX38CM TIBIAL I/M NAIL 13MMDX40CM TIBIAL I/M NAIL 14MMDX40CM TIBIAL I/M NAIL 15MMDX40CM TIBIAL I/M NAIL 13MMDX42CM TIBIAL I/M NAIL 14MMDX42CM TIBIAL I/M NAIL 15MMDX42CM TIBIAL I/M NAIL 11MMDX44CM TIBIAL I/M NAIL 13MMDX44CM TIBIAL I/M NAIL 14MMDX44CM TIBIAL I/M NAIL 11MMDX46CM TIBIAL I/M NAIL 12MMDX46CM TIBIAL I/M NAIL 13MMDX46CM

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph

    FDA Enforcement
    Class II ·Ongoing·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·July 30, 2025

    Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/DN R-F IM NAIL 10MM DIA 224001020 M/DN R-F IM NAIL 10MM DIA 224001022 M/DN R-F IM NAIL 10MM DIA 224001024 M/DN R-F IM NAIL 10MM DIA 224001026 M/DN R-F IM NAIL 10MM DIA 224001028 M/DN R-F IM NAIL 10MM DIA 224001030 M/DN R-F IM NAIL 10MM DIA 224001032 M/DN R-F IM NAIL 10MM DIA 224001034 M/DN R-F IM NAIL 10MM DIA 224001036 M/DN R-F IM NAIL 10MM DIA 224001038 M/DN R-F IM NAIL 10MM DIA 224001040 M/DN R-F IM NAIL 10MM DIA 224001042 M/DN R-F IM NAIL 10MM DIA 224001114 M/DN R-F IM NAIL 11MM DIA 224001116 M/DN R-F IM NAIL 11MM DIA 224001118 M/DN R-F IM NAIL 11MM DIA 224001120 M/DN R-F IM NAIL 11MM DIA 224001122 M/DN R-F IM NAIL 11MM DIA 224001124 M/DN R-F IM NAIL 11MM DIA 224001126 M/DN R-F IM NAIL 11MM DIA 224001128 M/DN R-F IM NAIL 11MM DIA 224001130 M/DN R-F IM NAIL 11MM DIA 224001132 M/DN R-F IM NAIL 11MM DIA 224001134 M/DN R-F IM NAIL 11MM DIA 224001136 M/DN R-F IM NAIL 11MM DIA 224001138 M/DN R-F IM NAIL 11MM DIA 224001140 M/DN R-F IM NAIL 11MM DIA 224001142 M/DN R-F IM NAIL 11MM DIA 224001144 M/DN R-F IM NAIL 11MM DIA 224001146 M/DN R-F IM NAIL 11MM DIA 224001218 M/DN R-F IM NAIL 12MM DIA 224001220 M/DN R-F IM NAIL 12MM DIA 224001224 M/DN R-F IM NAIL 12MM DIA 224001226 M/DN R-F IM NAIL 12MM DIA 224001228 M/DN R-F IM NAIL 12MM DIA 224001230 M/DN R-F IM NAIL 12MM DIA 224001232 M/DN R-F IM NAIL 12MM DIA 224001234 M/DN R-F IM NAIL 12MM DIA 224001236 M/DN R-F IM NAIL 12MM DIA 224001238 M/DN R-F IM NAIL 12MM DIA 224001240 M/DN R-F IM NAIL 12MM DIA 224001242 M/DN R-F IM NAIL 12MM DIA 224001244 M/DN R-F IM NAIL 12MM DIA 224001248 M/DN R-F IM NAIL 12MM DIA 224001318 M/DN R-F IM NAIL 13MM DIA 224001324 M/DN R-F IM NAIL 13MM DIA 224001326 M/DN R-F IM NAIL 13MM DIA 224001328 M/DN R-F IM NAIL 13MM DIA 224001330 M/DN R-F IM NAIL 13MM DIA 224001332 M/DN R-F IM NAIL 13MM DIA 224001334 M/DN R-F IM NAIL 13MM DIA 224001336 M/DN R-F IM NAIL 13MM DIA 224001338 M/DN R-F IM NAIL 13MM DIA 224001340 M/DN R-F IM NAIL 13MM DIA 224001344 M/DN R-F IM NAIL 13MM DIA 224001346 M/DN R-F IM NAIL 13MM DIA 224001348 M/DN R-F IM NAIL 13MM DIA 224001422 M/DN R-F IM NAIL 14MM DIA 224001436 M/DN R-F IM NAIL 14MM DIA 224001438 M/DN R-F IM NAIL 14MM DIA 224001440 M/DN R-F IM NAIL 14MM DIA 224001442 M/DN R-F IM NAIL 14MM DIA 224001444 M/DN R-F IM NAIL 14MM DIA 224001446 M/DN R-F IM NAIL 14MM DIA 224000922 M/DN R-F IM NAIL 9MM DIA 224000926 M/DN R-F IM NAIL 9MM DIA 224000928 M/DN R-F IM NAIL 9MM DIA 224000930 M/DN R-F IM NAIL 9MM DIA 224000932 M/DN R-F IM NAIL 9MM DIA 224000934 M/DN R-F IM NAIL 9MM DIA 224000936 M/DN R-F IM NAIL 9MM DIA 224000942 M/DN R-F IM NAIL 9MM DIA 224000946 M/DN R-F IM NAIL 9MM DIA 225320010 M/DN TIBIAL I/M NAIL 10MM 225326010 M/DN TIBIAL I/M NAIL 10MM 225328010 M/DN TIBIAL I/M NAIL 10MM 225330010 M/DN TIBIAL I/M NAIL 10MM 225332010 M/DN TIBIAL I/M NAIL 10MM 225334010 M/DN TIBIAL I/M NAIL 10MM 225336010 M/DN TIBIAL I/M NAIL 10MM 225338010 M/DN TIBIAL I/M NAIL 10MM 225344010 M/DN TIBIAL I/M NAIL 10MM 225320011 M/DN TIBIAL I/M NAIL 11MM 225322011 M/DN TIBIAL I/M NAIL 11MM 225324011 M/DN TIBIAL I/M NAIL 11MM 225326011 M/DN TIBIAL I/M NAIL 11MM 225328011 M/DN TIBIAL I/M NAIL 11MM 225330011 M/DN TIBIAL I/M NAIL 11MM 225332011 M/DN TIBIAL I/M NAIL 11MM 225334011 M/DN TIBIAL I/M NAIL 11MM 225336011 M/DN TIBIAL I/M NAIL 11MM 225338011 M/DN TIBIAL I/M NAIL 11MM 225340011 M/DN TIBIAL I/M NAIL 11MM 225342011 M/DN TIBIAL I/M NAIL 11MM 225344011 M/DN TIBIAL I/M NAIL 11MM 225346011 M/DN TIBIAL I/M NAIL 11MM 225328012 M/DN TIBIAL I/M NAIL 12MM 225330012 M/DN TIBIAL I/M NAIL 12MM 225332012 M/DN TIBIAL I/M NAIL 12MM 225334012 M/DN TIBIAL I/M NAIL 12MM 225336012 M/DN TIBIAL I/M NAIL 12MM 225338012 M/DN TIBIAL I/M NAIL 12MM 225340012 M/DN TIBIAL I/M NAIL 12MM 225346012 M/DN TIBIAL I/M NAIL 12MM 225324013 M/DN TIBIAL I/M NAIL 13MM

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 22, 2014

    Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a sterilization wrap and sterilized. This allows the customer to open one package for a surgical procedure instead of many individual packages.

    FDA Enforcement
    Class II ·Terminated·SRI Surgical·September 5, 2012

    Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D5 US154725 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 US154705 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B6 US154707 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B7 US154713 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C5 US154719 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C8 US154720 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D4 US154721 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D4 US154723 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D5 US154725 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 US154727 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 US154727 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 US154731 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, E4 US154735 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, E6 US154745 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6 US154745 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6 US154746 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, A7 US154711 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C4 US154734 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, E6 US154730 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, E4 US154711 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C4 Product Usage: Knee prosthesis

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·June 3, 2020

    Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523; 3) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC 840368511998; 4) SOL-M 3ml Slip Tip Syringe w/o Needle, Model No. P180003ST, UPC 810018097493; 5) SOL-M 5ml Slip Tip Syringe w/o Needle, Model No. P180005ST, UPC 810018097462; 6) SOL-M 10ml Slip Tip Syringe w/o Needle, Model No. P180010ST, UPC 810018097646; 7) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. P180020ST, UPC 810018098636; 8) SOL-M 30ml Slip Tip Syringe w/o Needle, Model No. P180030ST, UPC 810062435333; 9) SOL-M 60ml Slip Tip Syringe w/o Needle, Model No. P180060ST, UPC 810062435340; 10) SOL-M 1ml Slip Tip Syringe Sterile Convenience Tray, Model No. P180011T, UPC 810018098957

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

    Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091

    FDA Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·November 6, 2024

    Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;

    FDA Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·November 6, 2024

    PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15

    FDA Enforcement
    Class II ·Terminated·Zien Medical Technologies, Inc·September 30, 2015

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Avenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended Use: " Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. " Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR). " Acute traumatic fracture of the femoral head or neck " Avascular necrosis of the femoral head. " Avenir Moller Stems are for cementless use only.

    FDA Enforcement
    Class II ·Terminated·Zimmer Gmbh·August 3, 2016

    FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM PRC LT M/RT L REG+ FEM PRC RT M/LT L REG+ FEM PRC LT M/RT L LGE FEM PRC RT M/LT L LGE FEM PRC LT M/RT L LGE+ FEM PRC RT M/LT L LGE+ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280 Software Version: Not Applicable Product Description: The M Zn-Air Battery Pak is a disposable power source for the Naida" CI M and Sky CI" M Sound Processors. The type of disposable battery to be used with the M Zn-Air Battery Pak is a 675 power implant battery (P675). Regular 675 hearing instrument batteries will not be powerful enough for a cochlear implant. The suggested manufacturer and battery is PowerOne P675 Implant Plus battery. The M Zn-Air Battery Pak is available with non-tamperproof and tamperproof cartridges. Component: Not Applicable

    FDA Enforcement
    Class II ·Ongoing·Advanced Bionics, LLC·May 6, 2026