16 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MERETE LOCKING BONE PLATE SYSTEM III
FDA 510(k)
FDA Class 2
·Orthopedic
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564031273·EYE GOWN PACK
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319720332·Iris Tissue Forceps 4" (10cm), half curved, 1x2...
BD NEEDLE PRECISIONGLIDE 21X1IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·January 16, 2026
BD NEEDLE PRECISIONGLIDE 21X1IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·January 16, 2026
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERDICT-II PROPOXYPHENE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BD NEEDLE PRECISIONGLIDE 21X1IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·January 16, 2026
LINEAR ST
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 19, 2024
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 20, 2013
ACRYSOF
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·August 15, 2008
ACCESS® FREE T4 REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CEC·June 10, 2011
BD NEEDLE PRECISIONGLIDE 21X1IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMI·February 13, 2026
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024