13 results
·
35ms
·
Sources: EU EUDAMED, US FDA
Quadsense (Quadsense and Quadsense Pro)
FDA 510(k)
FDA Class 2
·Neurology
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813053140·NITI ROTARY FILE S45/T04 25MM DARBY
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124436·Modular Offset Stem 15mm x 125mm 4mm
BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·September 17, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014
AUTO ENDO5 ML
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·July 24, 2013
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·April 25, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·January 4, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·February 18, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·July 26, 2019
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024