12 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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