13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Fiber Disks and Blocks (TRINIA)
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814275·GENUMEDI PT SILVER R IV
LEONE SPA
FDA UDI
LEONE SPA·08033707012207·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 24
Segmental Plating System
FDA UDI
ALPHATEC SPINE, INC.·00190376544960·SPS FA Self-Drill Screw, 3.5 x 24 mm
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071147549·14F x 3.5cm MiniSPC Low Profile Suprapubic Cath...
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071150167·14F x 3.5cm MiniSPC Low Profile Suprapubic Cath...
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376695310·PROXIMITY FA SELF-DRILL SCREW, 3.5 x 24mm
ULTRASOUND SCANNER PRO FOCUS, MODEL 2202
FDA 510(k)
FDA Class 2
·Radiology
VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
FDA 510(k)
FDA Class 2
·General Hospital
RSP SHOULDER
FDA Adverse Event
Injury
·ENCORE MEDICAL, L.P.·Product code KWS·October 6, 2014
ADVIA CENTAUR XP TSH3-ULTRA (TSH3-UL) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JLW·June 3, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·June 2, 2011
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021