20 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Reusable Monopolar Active Cord
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Echo® Bi-Metric® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868274015·
Echo FX™ Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868260933·
ECHO BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304505964·
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198796·AK3 Ultra Insert Trial Size 5, 18mm
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780419396·Integra® Miltex® House Elevator 6-1/2", Tip 1mm...
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973108191·TRIAL 90-SRK-192518 POLY-MPCS 5X18 LEFT
NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180544167·Decompression Tube, 18 x 100mm
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180544143·Decompression Tube, 18 x 80mm
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180544150·Decompression Tube, 18 x 90mm
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180544129·Decompression Tube, 18 x 60mm
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180544136·Decompression Tube, 18 x 70mm
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180544112·Decompression Tube, 18 x 50mm
LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X320MM X 12
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 19, 2012
HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 5, 2011
MIRS POLYAXIAL SCREW BODY TAN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NKB·June 27, 2013
MEDRAD VERIS
FDA Adverse Event
Malfunction
·BAYER MEDICAL CARE, INC.·Product code MHX·September 26, 2014
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022