17 results
·
41ms
·
Sources: EU EUDAMED, US FDA
TRI-MED INFLATABLE ESOPHAGEAL DILATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LP Low Profile
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746087011·DB BKT LP LR 1ST BIC 018 T-12 A+2 R=0
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158212923·SCISSOR REYNOLDS STRAIGHT FINE 6"
ALPHAPOINTE
FDA registration
ALPHAPOINTE·6 products·🇺🇸 United States
Baby Gorilla®/Gorilla® Plating System
FDA UDI
Paragon 28, Inc.·00889795113689·Ø2.0mm x 15cm Threaded, K-Wire
Obtura Spartan
FDA UDI
Young Innovations, Inc.·00843471100950·EMS Threaded Tip KiS-5E
Obtura Spartan
FDA UDI
OBTURA SPARTAN ENDODONTICS·00816168020466·EMS Threaded Tip KiS-5E
EMBRYON ULTRASOUND NEEDLE GUIDE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·July 5, 2021
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·July 5, 2021
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 1, 2014
INSYNC SENTRY
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NIK·December 17, 2010
BAERVELDT SHUNT
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYF·August 7, 2019
IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·October 31, 2019
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021