10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040)
FDA 510(k)
FDA Class 1
·General Hospital
SURGISTAR
FDA UDI
SURGISTAR, INC.·00878799004574·
Ambler Surgical
FDA UDI
AMBLER SURGICAL CORP.·10190660200227·Slit knife, 3.5mm wide, angled NexGen blade, fu...
MOORLDLS LASER DOPPLER LINE SCANNER
FDA 510(k)
FDA Class 2
·Cardiovascular
URESIL THORACIC VENT
FDA 510(k)
FDA Class 2
·General Hospital
SYMBIQ SCHANNEL 3.01
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 23, 2014
ADVANTA SST
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORP.·Product code DSY·January 2, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 20, 2010
R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026