13 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

PIVIT A/B ST AND PIVIT A/B ST-R

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

BD INTEGRA SYRINGE W/ DETACHABLE NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·November 22, 2019

BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·December 2, 2021

EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

TROCHANTERIC DYAX NAIL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

UNK VOLBELLA

FDA Adverse Event
Injury ·ALLERGAN (PRINGY)·Product code LMH·April 27, 2020

EDWARDS ESHEATH INTRODUCER SET

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 6, 2021

EDWARDS TF SHEATH UNKNOWN

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·October 30, 2021

SECUR-FIT MAX 127 HIP STEM #8

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LZO·May 6, 2013

V60 VENTILATOR

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·September 16, 2014

HUT EXT DR FINAL ASSY-REVERSE

FDA Adverse Event
Malfunction ·LIEBEL-FLARSHEIM CO.·Product code KQS·April 5, 2011

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

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024