22 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AC POWERED THERMAL CAUTERY UNIT
FDA 510(k)
FDA Class 2
·Ophthalmic
Preclean Kit
FDA UDI
MEDIVATORS INC.·40677964007666·Preclean Plus Kit includes Pentax 4-piece Valve...
TruLock
FDA UDI
Rmo, Inc.·00885797644947·TRULOCK Primer Activated Adhesive Mini Kit (1ea...
Truliant
FDA UDI
Exactech, Inc.·10885862623737·Special Truliant DF FFG Uncaptured Anterior and...
BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY
FDA 510(k)
FDA Class 2
·Radiology
NOVA CORDLESS CURING LIGHT
FDA 510(k)
FDA Class 2
·Dental
BIOTRANS™ Pressure Monitoring Kits
FDA UDI
BIOPTIMAL INTERNATIONAL PTE. LTD.·08888893011592·
BIOTRANS™ Pressure Monitoring Kits
FDA UDI
BIOPTIMAL INTERNATIONAL PTE. LTD.·08886483502680·
BIOTRANS™ Pressure Monitoring Kits
FDA UDI
BIOPTIMAL INTERNATIONAL PTE. LTD.·08888893314020·
BIOTRANS™ Pressure Monitoring Kits
FDA UDI
BIOPTIMAL INTERNATIONAL PTE. LTD.·08888893314037·
BIOTRANS™ Pressure Monitoring Kits
FDA UDI
BIOPTIMAL INTERNATIONAL PTE. LTD.·08886483502703·
BIOTRANS™ Pressure Monitoring Kits
FDA UDI
BIOPTIMAL INTERNATIONAL PTE. LTD.·08886483502697·
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 30, 2024
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 24, 2011
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·February 21, 2008
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·October 14, 2022
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·October 14, 2022
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·October 14, 2022
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013