16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIZION DR
FDA 510(k)
FDA Class 2
·Radiology
2460 5 WAY STOPCOCK
FDA UDI
HANS RUDOLPH, INC.·00874750009497·2460A 5W STCK.187FB 7.5MM/.187
Cabel C3 Top Array 1.5T PH
FDA UDI
Noras MRI products GmbH·04251269204937·
ACCELEDENT
FDA 510(k)
FDA Class 2
·Dental
ARTHREX SCAPHOLUNATE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·February 5, 2009
WAVEWRITER ALPHA? PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 11, 2025
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CLONMEL·Product code NIQ·September 1, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013
3.4MM 90 LEFT ROTARY PUNCH
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code NBH·April 29, 2011
ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) PISTOL GRIP 36CM-15MM ACTIVE BL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GEI·August 11, 2008
LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 8, 2023
SUPERA PERIPHERAL STENT SYSTEM
FDA Adverse Event
Death
·ABBOTT VASCULAR·Product code NIP·June 19, 2020
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
FDA Enforcement
Class II
·Terminated·Ecolab Inc·February 19, 2014
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025