BEUDAMED
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    Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.

    FDA Enforcement
    Class II ·Terminated·Hologic, Inc.·June 11, 2014

    Lorad M-IV Mammography System

    FDA Recall
    Terminated ·Lorad, A Division of Hologic·Product code IZH·January 14, 2004

    Lorad MIV Platinum Mammograpgy System

    FDA Recall
    Terminated ·Lorad, A Division of Hologic·Product code IZH·January 14, 2004

    Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code IZH·May 13, 2014

    Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code MUE·May 13, 2014

    OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) OPHTALMIC DRAPE WITH POUCH LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (10) COTTON TIP APPLICATOR 6" WOOD (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 18G X 1 Y." (1) NEEDLE HYPODERMIC 25G X 5/8" (2) EYE PAD 2 1/8 X 2 5/8 UF (5) EYE SPEAR MICRO SPONGE (2) LITE GLOVE LIF (1) CABLE BIPOLAR (1) EYE SHIELD UNIVERSAL (1) OPHTALMIC PENCIL BIPOLAR (1) IV ADM. SET 15 DROPS 106" LONG L/F (1) TABLE COVER REINFORCED 50" X 90" UF (1) KNIFE/BLADE MIN. EDGE ROUND (1) KNIFE 15 5.0 CONTROLLED (1) PLASTIC TRAY 3/COMPARTMENT (1)KNIFE 3.2MM ANGLE BEVEL UP (1) CYSTOTOMO IRRIG. 25GA X5/8 (1) MAYO TRAY LARGE (2) GOWN STANDARD LARGE SMS STD VELCRO NECK (1) PVP PAINT 8" STICK SPONGE (1) NEEDLE & BLADE COUNTER 30c MAG/MAG/LF 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

    Breast Pack- FJG, code 900-3118, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTTOM (1) SYRINGE BULB 60CC (1) TUBE SUCTION CONNECT~" X 12' (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (1) BOWL UTIL TIY QUART 32oz (1) COVER MAYO STAND REINFORCED (2) SKIN MARKER WITH RULER (2) RULER (1) COVER TABLE REINFORCED 50" X 90" (2) CUP DENTURE 8oz TEAL WITH LID (6) TOWEL CLOTH HUCK BLUE (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) DRAPE BREAST/CHEST SMS (10) SPONGE LAP PREWASH 18" X 18" XRD (1) SHEET% DRAPE REINFORCED 60" X 77" (4) DRAPE UTILITY WITH TAPE (1) BLADE SURG. #15 CARBON STEEL (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 6.5 POWDER FREE (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7 POWDER FREE (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7.5 POWDER FREE (10) GAUZE SPONGE 4" X 4" 16PLY (1) PK. STRIP STERI CLOSURE W' X 4" (1) NEEDLE SPINAL ANESTH 22G X 3Y2 (1) NEEDLE HYPODERMIC 22G X 1Y2 (1) IV PRIMARY ADD ADMINISTRAT SET (1) STOPCOCK 3WAY WSWIVEL MALE (1) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK Product Usage: 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

    Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc). The manually operation of the DOLPHIN is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device. Instantaneous deflation, regardless of balloon size, is made possible by the release of the dual locks located on device as well as a large, 30 cc syringe that is sold with each Dolphin Inflation Device. All the while during inflation or deflation pressure is displayed and can be monitored on a large analog gauge mounted on top of the device.

    FDA Recall
    Terminated ·Vascular Solutions, Inc.·Product code MAV·April 12, 2017

    Merit Inflation Syringe Kit. Catalog Number KOS-02857

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code MAV·August 25, 2016

    Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monitor pressure within the balloon. The Everest 20atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20bars in 0.5 bar increments. The Everest 30atm Device is outfitted with a manometer with measuring pressures ranging from vacuum to 30bars in 0.5 bar increments. The manometers are accurate to within +/- 3% of the gauges full scale. The device is a sterile, single use device and is not implanted; it also does not come in direct contact with the patient. This product is packaged in an inner and outer Tyvek /poly layer pouch.

    FDA Recall
    Terminated ·Medtronic Vascular·Product code MAV·February 6, 2014

    Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both primary and revision applications. Indications: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis when one or more compartments are involved, 2) correction of varus, valgus, or posttraumatic deformity, 3) correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure

    FDA Recall
    Terminated ·Biomet, Inc.·Product code MBV·November 15, 2012

    Viceroy Inflation Syringe, 60mL, without gauge.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code MAV·October 21, 2005

    IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface 10m cable

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code MAV·November 7, 2005

    IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial interface 10m cable.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code MAV·November 7, 2005

    Medtronic Everest 30 Disposable Inflation Device, AC3200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code MAV·July 16, 2010

    Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter

    FDA Recall
    Terminated ·PEROUSE MEDICAL ROUTE DU MANOIR Ivry Le Temple France·Product code MAV·October 6, 2014

    Medtronic Everest 20 Disposable Inflation Device, AC2200. Used to inflate/deflate balloon catheters as well as to monitor pressure within the balloon.

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code MAV·July 16, 2010

    PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).

    FDA Recall
    Terminated ·Abbott Vascular·Product code MAV·July 3, 2018

    DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code MAV·June 7, 2017

    Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.

    FDA Recall
    Terminated ·Perouse Medical 135, Route Neuve Irigny France·Product code MAV·May 10, 2012