10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GE DATEX-OHMEDA AISYS
FDA 510(k)
FDA Class 2
·Anesthesiology
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036028022·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776363369·Exodontia Oral Curette
MENICON SF-P
FDA 510(k)
FDA Class 2
·Ophthalmic
POWDER FREE NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
VERSAFITCUP FLAT PE HC LINER Ø 36 / F
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 27, 2016
QUADRA ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 2, 2013
BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·September 15, 2014
HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 16, 2011
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