16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ETEST LINEZOLID
FDA 510(k)
FDA Class 2
·Microbiology
USB-Dongle red
FDA UDI
ZIRKONZAHN SRL·D800KT002139·USB-Dongle red for Zirkonzahn Scanner
artVeneer life
FDA UDI
Merz Dental GmbH·D7092002139·artVeneer life lower posteriors, XS, D2
CURE OPEL-L (S)
FDA UDI
MEDITECH SPINE, LLC·B167900021390·
CURE OPEL-L (S)
FDA UDI
MEDITECH SPINE, LLC·B167S1900021390·
PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M
FDA 510(k)
FDA Class 2
·Cardiovascular
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED
FDA 510(k)
FDA Class 1
·General Hospital
ENDOTAK C TRANSVENOUS DEFIBRILLATION LEAD
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS·Product code LWS·January 16, 1997
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·September 14, 2011
2520274-2013-10215
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code MNI·February 11, 2013
ACCU-CHEK FLEXLINK PLUS
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FRN·February 4, 2011
PUMP MMT-515NAP PRDGM INS V2.1 PL EN
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·February 25, 2008
Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
FDA Enforcement
Class I
·Ongoing·Hamilton Medical, Inc.·September 27, 2023
Colonoscope, Model Number CF-H180AL.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 6, 2024
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024