14 results · 27ms · Sources: EU EUDAMED, US FDA

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Epi-Stop Nasal Gel/epistaxis pack

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780382607·Integra® Jarit® Dean Rongeur, 5-3/4", 5mm Bite,...

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113943·B-H IRRIGATING CAN 19GA FLAT ANGLED 8MM

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036035303·

Restore

FDA UDI
KEYSTONE DENTAL, INC.·D768L23014200K0·Temp Abutment

Restore

FDA UDI
KEYSTONE DENTAL, INC.·D768L23014201K0·Temp Abutment

THERMACOOL TC SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

FLIXENE IFG VASCULAR GRAFT

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 17, 2008

UNKNOWN DEPUY ASR HEAD

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·September 1, 2011

BRYAN® CERVICAL DISC SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code MJO·July 16, 2013

Agilent Resolution ctDx FIRST Sample Collection Kit, 500032

FDA Enforcement
Class III ·Ongoing·AGILENT TECHNOLOGIES INC./US·April 19, 2023

UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

FDA Enforcement
Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014