9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VV330 Continuous ECG Platform, VivaLNK Adhesive Patch
FDA 510(k)
FDA Class 2
·Cardiovascular
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180543702·70mm Cervical Tooth Blade, Wide
SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
TORNIER, PITON FIXATION IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LQC·October 1, 2008
PT ROOM WALL SAVER RECL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FRK·July 29, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 26, 2013
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
FDA Enforcement
Class II
·Ongoing·Cook Vandergrift, Inc.·September 13, 2023
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024