13 results
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23ms
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Sources: EU EUDAMED, US FDA
GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606866·GETINGE / SHAMPAINE 4900/5100B, 5100E 4.25" SOF...
Cordera hip system
FDA UDI
Conformis, Inc.·00810933031312·Cordera Stem Acetate 110 percent Magnification ...
UNKNOWN SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015
RANDOX FERRITIN
FDA 510(k)
FDA Class 2
·Immunology
MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·August 17, 2022
ROI-C MONOBLOCK TRIAL 14X17MM H7MM (YELLOW)
FDA Adverse Event
Injury
·LDR MEDICAL·Product code ODP·April 9, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·May 6, 2011
ANALYTICAL P MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 22, 2008
145-DEG PE 46MM HUM LINER +2.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·September 17, 2024
COPELAND THN SHL COCR/HA HUMS3
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWS·August 28, 2025
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