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    Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled and packaged into a shipping carton or into a holding tray which is then placed into a shipping carton. Designed for use in spine surgery to assist in the tapping procedure and the placement of screws during the surgery.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·July 8, 2015

    Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top Nonsterile TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 27, 2014

    PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 GH; L 10-12 J; R 3-5 CD; R 6-9 CD; R 3-5 EF; R 6-9 EF; R 10-11 EF; R 6-9 GH; R 10-12 GH; and R 10-12 J.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6-9 GH Top; Size 10-12 GH Top; Size 10-12 J Top; and RIGHT Size 3-5 CD Top; Right Size 6-9 CD Top; Right Size 3-5 EF Top; Right Size 6-9 EF Top; Right Size 10-11 EF Top; Right Size 6-9 GH Top; Right Size 10-12 GH Top; and Right Size 10-12 J Top.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 27, 2014

    Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Enforcement
    Class II ·Terminated·Pro-Dex Inc·March 23, 2016

    Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Enforcement
    Class II ·Terminated·Pro-Dex Inc·March 23, 2016

    VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department.

    FDA Enforcement
    Class II ·Terminated·Del Medical, Inc.·February 17, 2016

    VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department.

    FDA Enforcement
    Class II ·Terminated·Del Medical, Inc.·February 17, 2016

    PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.

    FDA Enforcement
    Class II ·Terminated·Pro-Dex Inc·August 28, 2019

    CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus Anesthesia Workstation: The Blease Frontline Plus Range, Anesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. BleaseSirius Anesthesia Workstation: The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.

    FDA Enforcement
    Class I ·Terminated·Del Mar Reynolds Medical, Ltd.·November 27, 2013

    Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not requiring portability.

    FDA Enforcement
    Class I ·Terminated·Del Mar Reynolds Medical, Ltd.·March 27, 2013

    Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·July 31, 2013

    SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.

    FDA Enforcement
    Class I ·Terminated·Del Mar Reynolds Medical, Ltd.·April 23, 2014

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012

    Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual ventilation in the event of a power failure scenario. Clinicians are able to use Emergency O2 and manually ventilate the patient, providing gas and agent. However, the anesthesiologist will not have access to mechanical ventilation or ventilator monitoring.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·March 22, 2017

    Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·May 24, 2017

    Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·April 29, 2015

    LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWELS 15" X 20" LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (1) SURGICAL DURAPREP SOLUTION 26ml LIF (1) TUR Y SET 81 "2.1M REGULAR CLAM ST. (1) DRAPE LASER CAMERA W/EL 6" X 96" (1) LAPAROSCOPY ABDOMINAL DRAPE W/POUCH L/F (1) TABLE COVER 44" X 90" (1) MAYO STAND REINFORCED L/F (1) SURGICAL BLADE # 11 CARBON STEEL (1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR L/F (1) TUBE SUCTION CONNECTING W' X 12' LIF (1) TROCAR ENDOPATH XCEL DILATING TIP 5MM(K5LT) LIF (1) CEF AZOLIN RED LABEL (1) GENTAMICIN GREEN LABEL (1) AZUL DE METILENO LABEL (1) HEPARINE WHITE LABEL (1) LIDOCAINE YELLOW LABEL 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

    40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.

    FDA Enforcement
    Class II ·Terminated·ICU Medical de Mexico, S.A. de C.V.·August 22, 2018