14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRABECULAR METAL KNEE SYSTEM AUGMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
Mini Master Series Bracket
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746070860·1 PAT SETUP MINI MS MBT 022 U/L 5X5 W/HK 3 UL3 ...
BIPOLAR PENCIL, MODEL 3901-002, 3900-002
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDTRADE PRODUCTS ALGINATE ISLAND
FDA 510(k)
FDA Unclassified
·Unknown
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Injury
·ANGIOMED GMBH & CO.·Product code FGE·November 21, 2008
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO.·Product code FGE·November 5, 2008
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code FGE·February 20, 2009
INCLUSIVE TAPERED IMPLANT 5.2MMD X 8MML X 4.5 MMP
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 12, 2025
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO.·Product code FGE·November 4, 2008
LIFESTENT FLEXSTAR XL BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO, MEDIZINTECHNIK·Product code FGE·February 13, 2009
GREENLIGHT HPS BPH FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·April 3, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·August 27, 2014
CUSTOM PAK
FDA Adverse Event
Injury
·S.A. ALCON- COUVREUR N.V., ALCON - BELGIUM·Product code KYG·May 9, 2008
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024