12 results · 31ms · Sources: EU EUDAMED, US FDA

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SPECTRA SYSTEM DENTAL IMPLANTS 2008

FDA 510(k)
FDA Class 2 ·Dental

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036028046·

COZART EIA COCAINE ORAL FLIUD KIT

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

A1CNOW FOR RX HOME USE

FDA 510(k)
FDA Class 2 ·Hematology

VKMO 78000 3 QUADROX-I HMO 70000+VHK7000

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015

VKMO 78000 #QUADROX-I HMO 70000+VHK7000

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015

HLM TUBING SET W/SOFTLINE COATING

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWF·April 6, 2016

QUADRA ASSURA CRT-D, DF4 CONNECTOR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 2, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 15, 2014

OT SELECT METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·May 16, 2011

BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Company·September 3, 2014

Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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