7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
UNITED SURGICAL CORP. CRYOPTIC PLUS
FDA 510(k)
FDA Class 2
·Ophthalmic
BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B
FDA 510(k)
FDA Class 2
·Radiology
QuantX
FDA 510(k)
FDA Class 2
·Radiology
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 12, 2014
STERRAD NX STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·December 12, 2012
DEPUY ASR XL FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·June 25, 2015
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024