12 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SOLO INSULIN PATCH PUMP
FDA 510(k)
FDA Class 2
·General Hospital
AMARA
FDA UDI
Respironics, Inc.·00606959025080·AMARA MASK WITH RS FRAME AND HEADGEAR, MEDIUM, ...
CT/MR Ring & Tandem Set, 26mm, 45ø, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330022530·
CT/MR R&T Ring Tube, 45ø, 26mm ring only, Varian
FDA UDI
MICK RADIO NUCLEAR INSTRUMENT, INC·00817330022547·
CSM STRETTA SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACTIVHEAL SCAR MANAGEMENT DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 10, 2022
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·May 2, 2013
SURGILAV PLUS HANDPIECE SET WITH MULTI-ORIFICE TIP
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS PUERTO RICO·Product code FQH·April 19, 2011
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code JDI·July 30, 2008
VERSAFITCUP ACETABULAR SHELL Ø56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·April 26, 2023
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