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    Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.

    FDA Enforcement
    Class I ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·November 28, 2012

    Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05400-NRF ASK-05500-NRON EJ-05400-NRON OU-05500-NRON TU-05500-NRON The Arrow Epidural Catheter kit permits access to the epidural space for administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.

    FDA Enforcement
    Class II ·Ongoing·Arrow International Inc·June 17, 2020

    Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable

    FDA Enforcement
    Class II ·Ongoing·Agilent Technologies Denmark ApS·September 24, 2025

    NEURO SPINE PACK - (1) BAG SUTURE FLORAL (1) COVER TABLE 44" X 90" (4) ABSORBENT TOWELS 15" X 20" UF (1) LAPAROTOMY T DRAPE 102" X 78" X 121" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (3) GOWN IMP. EXTRA REINFORCED LARGE TIWRAP (1) DURAPREP SURGICAL SOLUTION 26mL UF (1) INCISION DRAPE 23" x 17" (1) INSTRUMENT POUCH (2) CAUTERY TIP POLISHER LIF (1) CAUTERY PENCIL HANDSWITCHING LIF (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) YANKAUER SUCT. TUBE WITHOUT VENT LIF (2) LITE GLOVES LIF (1) TUBE SUCTION CONNECT. Y.." X 12' LIF (1) SKIN MARKER WITH RULER (1) INCISE DRAPE ANTIMICROBIAL 23"x17" LIF (1) Pk SURGICAL STRIP W'X 6" (5) LAP SPONGES PRE-WASH 18" X 18" XRD L/F (20) GAUZE SPONGE 4"X 4" 16 PLY XRD LIF (1) SCALPEL WITH HANDLE #10 STAINLESS STEEL (5) DRAPE % ECONOMY 53" X 77" LIF (2) TABLE COVER HD 77" X 110" L!F (1) MAYO TRAY LARGE (1) UTILITY BOWL 16 oz LIF (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F (2) SYRINGE 10cc WITHOUT NEEDLE LIL UF (1) SCALPEL WITH HANDLE #15 STAINLESS STEEL (1) J VAC RESERVOIR 300 mL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe to profound hearing loss. It consists of internal and external components. The internal components include a stimulator (HiRes90K ICS) and electrode array (HiFocus 1j or Helix). The HiRes90K ICS is implanted surgically under the skin behind the ear. The electrode array is inserted into the cochlea. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. The Helix consists of a fantail, electrode lead, and Helix electrode array. The electrode, comprised of platinum-iridium wires, is housed in a silicone carrier and extends from the titanium case. The Helix electrode array is 24.5 mm in length and is designed to be inserted approximately 18-21 mm into a normal patent cochlea. It consists of 16 planar contacts arranged along the medial surface of the electrode array for stimulation of discrete segments of the cochlea. The Helix electrode insertion tool is designed to assist the surgeon with the insertion of the Helix electrode. Only the Helix insertion should be used for insertion of the Helix electrode; the use of other instruments may result in damage to the electrode. The insertion tool is a single-use instrument.

    FDA Enforcement
    Class II ·Terminated·Advanced Bionics Corporation·October 31, 2012

    - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is an oral lock connector. Product is considered sterile.

    FDA Enforcement
    Class II ·Terminated·Medela Inc. EF Division·March 18, 2015

    Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant

    FDA Enforcement
    Class II ·Ongoing·MED-EL Elektromedizinische Gereate, Gmbh·July 24, 2024

    SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.

    FDA Enforcement
    Class II ·Terminated·MED-EL Elektromedizinische Gereate, Gmbh·March 8, 2017

    MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

    FDA Enforcement
    Class II ·Terminated·MED-EL Elektromedizinische Gereate, Gmbh·August 14, 2019

    MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium; f. Mi1000 CONCERTO PIN +Standard; g. M11000 CONCERTO +Compressed Product Usage: The Mi1000 CONCERTO Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

    FDA Enforcement
    Class II ·Terminated·MED-EL Elektromedizinische Gereate, Gmbh·August 14, 2019

    MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product Usage: The SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

    FDA Enforcement
    Class II ·Terminated·MED-EL Elektromedizinische Gereate, Gmbh·August 14, 2019

    DONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15, UNIVERSAL, Rx ONLY, UDI: (01) 00190446683667 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

    FDA Enforcement
    Class II ·Terminated·DJ Orthopedics de Mexico S.A. de C.V.·May 5, 2021

    DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

    FDA Enforcement
    Class II ·Terminated·DJ Orthopedics de Mexico S.A. de C.V.·May 5, 2021

    DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

    FDA Enforcement
    Class II ·Terminated·DJ Orthopedics de Mexico S.A. de C.V.·May 5, 2021

    DONJOY REF:11-0447-9-ULTRASLING PRO, UNIVERSAL, Rx ONLY, UDI:(01)00190446673552 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

    FDA Enforcement
    Class II ·Terminated·DJ Orthopedics de Mexico S.A. de C.V.·May 5, 2021