13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Phantom Metatarsal Shortening System
FDA 510(k)
FDA Class 2
·Orthopedic
ASO Ankle Stabilizer
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357231843·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114100·SIMCOE CORTEX EXTRACTOR 21GA 0.4MM PK/10
FINN CHAMBERS AQUA
FDA 510(k)
FDA Class 1
·General Hospital
ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CADD
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·April 28, 2022
1823260-2017-02035
FDA Adverse Event
Malfunction
·September 21, 2017
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·August 25, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 12, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025