BEUDAMED
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    8F LAUNCHER GUIDE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    All Purpose Cuff

    FDA UDI
    SUNTECH MEDICAL, INC.·10840935102786·

    WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VISULAS 532S

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021

    FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·January 10, 2019

    LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·January 10, 2019

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 27, 2013

    DEPUY ASR XL FEM IMP SIZE 45

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·March 2, 2011

    MEDISENSE OPTIUM

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·April 2, 2008

    AVENIR MUELLER, STEM, STANDARD, UNCEMENTED, HA, 3, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·January 10, 2019

    LINER STANDARD 3.5 MM

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code LPH·October 21, 2019

    COCR HEADS

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code LPH·October 21, 2019

    Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 17, 2019

    Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Model Number 400, 404, V400, V450; 3. Lap 18X18 XR w/ring (5 each/pack, 40 pack/case) - Model Number 402; 4. Lap 4X18 XR (5 each/pack, 40 pack/case) - Model Number 407; 5. Lap 12X12 XR (5 each/pack, 40 pack/case) - Model Number 411; 6. Lap 12X12 XR w/ring (5 each/pack, 40 pack/case) - Model Number 412; 7. Lap 8X36 XR (5 each/pack, 40 pack/case) - Model Number 419; 8. Lap 17X26 XR (5 each/pack, 20 pack/case) - Model Number 426;

    FDA Enforcement
    Class II ·Terminated·Medical Action Industries Inc·April 3, 2019

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012