BEUDAMED
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    V*CARE MANUAL RESUSCITATOR, CAT#VR-1000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613026059·Gorney Dissecting Scissors, Straight, Blunt Tip...

    Stryker Universal Select Sterilization Tray System

    FDA UDI
    PARAGON MEDICAL, INC.·00857387006039·Two Level Rack

    VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    WAVi SCAN EEG System and Accessories

    FDA 510(k)
    FDA Class 2 ·Neurology

    32MM MOD HEAD COCR -6MM NECK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·September 3, 2021

    G7 HI-WALL E1 LINER 32MM F

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·September 3, 2021

    Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Degenerative Disk Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); -Spondylolisthesis; -Spinal Stenosis; -Fracture/dislocation; -Atlantoaxial fracture with instability; -Occipitocervical dislocation; -Revision of previous cervical spine surgery; and -Tumo

    FDA Enforcement
    Class II ·Terminated·Synthes USA HQ, Inc.·August 7, 2013

    AKREOS ADAPT AO MICRO INCISION LENS

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code HQL·November 30, 2010

    X3 TRIATHLON INSERT CR#7 11MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·January 14, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 3, 2014

    Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the Synthes Cervifix; Axon and Synapse Systems are indicated for the following: -Degenerative Disk Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); -Spondylolisthesis; -Spinal Stenosis; -Fracture/dislocation; -Atlantoaxial fracture with instability; -Occipitocervical dislocation; -Revision of previous cervical spine surgery; and -Tumo

    FDA Recall
    Terminated ·Synthes USA HQ, Inc.·Product code LXH·October 12, 2012