13 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493766·
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00846795001538·
ANYRIDGE INTERNAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZF·September 17, 2014
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code JDI·May 18, 2011
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·March 3, 2025
AXIUM PRIME BRPL 3D
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·April 6, 2021
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
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 L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025