12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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