13 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HIGHERDOSE Red Light Hat (HG-120K)
FDA 510(k)
FDA Class 2
·Physical Medicine
Artman Instruments
FDA UDI
Wise Linkers, LLC·D1272423631·Dental Examination Mirror Probe Tweezers with S...
NA
FDA UDI
Medos International Sàrl·10886705029242·ADAPTOR WOLF INSTRUMENT UNIVERSAL TIP
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331153433·deschamps ligature carrier, sharp, right, 8" (2...
THERAPY ABLATION CATHETER
FDA Adverse Event
Malfunction
·IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY·Product code OAD·June 25, 2010
HBP7 Settable Hemostatic Bone Putty
FDA 510(k)
FDA Unclassified
·Unknown
NUSTAT, NUSTAT XR
FDA 510(k)
FDA Unclassified
·Unknown
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
COBAS 8000 C 702 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·January 29, 2018
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·November 21, 2008
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 10, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 23, 2013
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014