12 results · 21ms · Sources: EU EUDAMED, US FDA

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CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL

FDA 510(k)
FDA Class 2 ·Immunology

XENMATRIX

FDA UDI
Davol Inc.·00801741031434·XenMatrix Surgical Graft, 19 cm x 28 cm (7.5" x...

MEDISLIM

FDA Adverse Event
Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

VENTRALEX ST HERNIA PATCH

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CORONIS COLOR 2MP AND MDCC 2121

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 24, 2025

STEM: AMISTEM H HA COATED STD STEM SIZE 2

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 2, 2019

RESERVOIR 3ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 10, 2014

COAGUCHEK ® XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·June 11, 2013

ICEMAN THERAPY UNIT

FDA Adverse Event
Injury ·DJ ORTHOPEDICS DE MEXICO·Product code ILO·July 11, 2011

XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 19 x 28 cm Rectangle Catalog #: 1161928

FDA Recall
Terminated ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTM·January 7, 2011

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