10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Spectra Soft Tissue Biopsy Needles
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Preat
FDA UDI
Preat Corporation·00842092155158·Equator Abutment for Astra EV 3.6 x 2mm
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383553483·Gutta Percha Points is used to root canal filin...
EASYSUITE SURGICAL LIGHT CONTROL (ESLC)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INSTANT-X, MODELS 1713 & 128
FDA 510(k)
FDA Class 2
·Radiology
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 20, 2025
PERSONA TRABECULAR METAL TIBIAL COMPONENT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JWH·May 24, 2013
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 23, 2011
PUMP MMT-722NAP PRDGM INS V2.2 PL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 27, 2008
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015