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