16 results · 18ms · Sources: EU EUDAMED, US FDA

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SELECTRON REMOTE ISOTOPE

FDA 510(k)
FDA Class 2 ·Radiology

GYNECARE TVT

FDA UDI
Ethicon Sàrl·10705031062238·Reusable Introducer

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K1100510·Caddie, 5.5mm Screws

AMC

FDA UDI
Advantage Medical Electronics, LLC·00849593001052·6 Lead Reusable NK To Pinch, Shield, 51", AHA

AMC

FDA UDI
Advantage Medical Electronics, LLC·00849593025591·6 Lead Reusable NK To Pinch, Shield, 51", AHA

AMC

FDA UDI
Advantage Medical Electronics, LLC·00849593001021·6 Lead Grouped NK To Snap, AHA, 51"

POLY-TAPES WITH THE FASTLOK FIXATION DEVICE

FDA 510(k)
FDA Class 2 ·Orthopedic

RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT

FDA 510(k)
FDA Class 2 ·Cardiovascular

POLY-TAPE, 20 X 500MM

FDA Adverse Event
Injury ·XIROS·Product code JDR·December 6, 2011

FRESENIUS 2008K

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·April 25, 2014

ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36 CM - 15 MM ACT

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GEI·November 12, 2007

M2A-MAGNUM MOD HD SZ 44MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·October 31, 2012

GALAXY G3 2.5MM X 5CM

FDA Adverse Event
Death ·MEDOS INTERNATIONAL SARL·Product code KRD·October 14, 2020

Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326

FDA Enforcement
Class II ·Ongoing·Stryker Corporation·May 13, 2020

Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282

FDA Enforcement
Class II ·Ongoing·Stryker Corporation·May 13, 2020

Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024