15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
REUNION Sacroiliac Joint Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Richard Wolf GmbH·04055207057377·TEM - COMBINATION-UNIT BNDL
ReVeneer Primer
FDA UDI
Schütz Dental GmbH·ESDG2322111·ReVeneer is an intraoral and extraoral repair s...
Critical Cover
FDA UDI
Alpha Pro Tech, Inc.·10817583023176·Scrub Shirt, AlphaGuard, Dark Blue, Long Sleeve...
FASTTAKE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·September 5, 2002
SKAFFOLD NMX BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
Disposable Medical Surgical Face Masks
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
ACRYSOF TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./ HUNTINGTON·Product code HQL·November 14, 2008
MEDTRONIC
FDA Adverse Event
Injury
·MEDTRONIC·Product code LGW·August 26, 2011
PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·July 8, 2013
OT VERIO FLEX METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 20, 2016
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·December 16, 2019
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·February 21, 2022
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