18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Montage Flowable Settable, Resorbable Bone Paste
FDA 510(k)
FDA Class 2
·Orthopedic
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022724·Dornier 600 µm Single-Use SMA Diode Laser Fiber...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111163197·SKLARLITE SKLRCT IRIS CVD 4.5"
ELMED
FDA UDI
ELMED INCORPORATED·00842180161078·Prism Cervical Curette, 10", Angled 2, Dark Blue.
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
FDA 510(k)
FDA Class 2
·Immunology
CIV-Clear cover
FDA 510(k)
FDA Class 2
·Radiology
DRILL, AO, STERILE 4, 2X340 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 23, 2011
OPTILITE® FREELITE® KAPPA FREE KIT
FDA Adverse Event
Injury
·THE BINDING SITE LIMITED·Product code DFH·March 30, 2026
OPTILITE® FREELITE® KAPPA FREE KIT
FDA Adverse Event
Injury
·THE BINDING SITE LIMITED·Product code DFH·March 31, 2026
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 1, 2011
ARTICULATED ECCENTER EXTRACTOR F/GUIDE B
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWB·July 17, 2013
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·September 16, 2024
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·May 21, 2024
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·October 28, 2025
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·April 17, 2024
CARTO 3
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DQK·October 15, 2025
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