18 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Avance Foam Dressing Kit - XL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XENMATRIX
FDA UDI
Davol Inc.·00801741031441·XenMatrix Surgical Graft, 19 cm x 35 cm (7.5" x...
SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
CENTERVUE DIGITAL RETINOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
STEM: AMISTEM H HA COATED STD SIZE 6
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 25, 2021
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 10, 2014
MX-PRO R-3 AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 11, 2013
MICROSENSOR VENTRICULAR CATHETER KIT
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code GWM·July 11, 2011
XenMatrix Surgical Graft ,Sterile, Porcine Dermal Matrix 19 x 35 cm Rectangle Catalog #: 1161935
FDA Recall
Terminated
·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTM·January 7, 2011
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·May 6, 2021
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 7, 2025
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2020
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2020
LZOVERSAFITCUP CC TRIO NO HOLE CUP
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 3, 2019
MPACT ACETABULAR SHELL Ø52 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·August 29, 2018
BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·April 11, 2019
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014