12 results
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19ms
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Sources: EU EUDAMED, US FDA
MAGILL FORCEPS, ADULT, 10 + SS 410 OR 420
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Kwik Kleen
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657072144·Kwik Kleen Kerrison 1mm x 200mm x 90 Deg
K-SPRAY, MODEL 085-2715
FDA 510(k)
FDA Class 1
·Dental
CALM CURVE, VERSION 01.00
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
ELECSYS HIV DUO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code MZF·December 17, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 14, 2012
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 4, 2010
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015