16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL
FDA 510(k)
FDA Class 2
·Dental
XLIF
FDA UDI
Nuvasive, Inc.·00887517055538·NAV.S XLIF Trial, 8x18mm 10° Lollipop
XLIF
FDA UDI
Nuvasive, Inc.·00195377026392·XLIF AMS Trial, 8x18mm 10° Lollipop
XLIF
FDA UDI
Nuvasive, Inc.·00887517053763·XLIF AMS Trial, 8x18mm 10° Modular
Sof-Flex
FDA UDI
COOK INCORPORATED·00827002150256·Sof-Flex Loop Suprapubic Catheter Set
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180505069·PLIF/TLIF Endplate Scraper, Straight, 12mm
URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
FDA 510(k)
FDA Class 2
·Orthopedic
AVISTA MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 19, 2024
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013
ACCU-CHEK FLEXLINK PLUS
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FRN·April 13, 2011
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS, AB·Product code LXB·July 25, 2008
CANNULA & CATHETER
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DWF·April 22, 2025
Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015