22 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00844856086883·POLYAXIAL REDUCTION SCREW, 7.2mm X 115mm
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00190376074245·Polyaxial Screw, 7.2 mm x 115 mm
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00844856084551·POLYAXIAL SCREW, 7.2mm X 115mm
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00190376078045·Polyaxial Reduction Screw, 7.2 mm x 115 mm
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215022327·
Arsenal
FDA UDI
ALPHATEC SPINE, INC.·00844856085701·SACRAL POLYAXIAL SCREW, 7.2mm X 115mm
A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
SERIM BLOOD LEAK TEST STRIP-2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Crescendo Meniscal Insert CR Standard 12mm Size 5
FDA UDI
AMPLITUDE SAS·03701089524353·
CAPIOX HEMOCONCENTRATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code KDI·March 3, 2016
SYNFRAME HALF RING
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code LXH·November 13, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
*
FDA Adverse Event
B BRAUN·Product code FMI·April 21, 2011
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008
SYNFRAME HALF RING
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code LXH·November 13, 2014
CAPIOX RX OXYGENATOR
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 31, 2024
SYNFRAME HALF RING
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·November 18, 2020
PHENOM CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code QJP·August 18, 2025
AXIUM PRIME BRPL 3D
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·March 23, 2022