13 results · 35ms · Sources: EU EUDAMED, US FDA

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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