18 results
·
20ms
·
Sources: EU EUDAMED, US FDA
DUAL LOCK HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
IRRIGATION CAP
FDA 510(k)
FDA Class 1
·General Hospital
POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Death
·ZOLL LIFECOR CORPORATION·Product code MVK·February 15, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·February 7, 2011
UNKNOW DEPUY METAL LINER
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·August 5, 2014
SAFIL UNDYED 5/0 (1) 70CM HR17 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·October 5, 2019
SAFIL VIOLET 2/0 (3) 70CM DS24 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·June 4, 2019
SAFIL VIOLET 5/0 (1) 45CM DS12 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·June 18, 2019
SAFIL VIOLET 2/0 (3) 70CM FR26 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·February 17, 2020
SAFIL UNDYED 4/0 (1,5) 70CM DS19 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·November 25, 2019
SAFIL UNDYED 5/0 (1) 45CM DS12 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·October 3, 2019
SAFIL UNDYED 4/0 (1,5) 70CM DS19 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·November 25, 2019
SAFIL VIOLET 5/0 (1) 45CM DS12 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·June 18, 2019
SAFIL VIOLET 2/0 (3) 70CM DS24 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·June 4, 2019
SAFIL VIOLET 0(3,5)8X45CM HR40S TO(M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·July 29, 2019
SAFIL VIOLET 1 (4) 70CM HR40S (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·December 18, 2019
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024