15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UNKNOWN SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015
COMPREHENSIVE REVERSE SHOULDER
FDA 510(k)
FDA Class 2
·Orthopedic
COPELAND THN SHL COCR/HA HUMS3
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWS·August 28, 2025
Conformis Hip System
FDA UDI
Conformis, Inc.·00810933031060·CUP IMPACTOR, LONG THREAD
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606743·GETINGE / SHAMPAINE 1501 RADI-OP 3.25" SOFTCARE...
SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
PLEURX PLEURAL CATHETER AND DRAINAGE KITS
FDA 510(k)
FDA Class 2
·Cardiovascular
ORTHOBLAST
FDA Adverse Event
Injury
·INTEGRA LIFE SCIENCES·Product code MBP·September 27, 2013
BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·October 13, 2022
BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·November 9, 2022
LCP-PLT 4.5/5 R 7HO L180 TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·April 26, 2013
FREESTYLE BREAST PUMP
FDA Adverse Event
Injury
·MEDELA AG·Product code HGX·April 25, 2011
LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code MAF·July 22, 2008
Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014