15 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Exablate Prostate System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517298560·CoRoent® XL-XW, 12x26x50mm 10°
Pro Advantage
FDA UDI
NATIONAL DISTRIBUTION & CONTRACTING, INC.·M220P2121505·Pro Advantage Cautery Vasectomy Hi Temp
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112861·CORNEAL TREPHINE BLADE6.0MM
Ti-Fix OLIF Spacer
FDA UDI
Tyber Medical, LLC·M695P32121500·Ti-Fix OLIF Spacer 32 x 12 x 15 (mm) x 0 °
PROFEMUR GLADIATOR HA HIP STEM
FDA 510(k)
FDA Class 3
·Orthopedic
PATTON ENDO-BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 5, 2007
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 28, 2012
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·September 22, 2021
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 29, 2014
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 8, 2011
COULTER® AC*T DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 8, 2013
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025