48 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NOVABONE-BIOGLASS BONE GRAFT PARTICULATE
FDA 510(k)
FDA Class 2
·Dental
PowerPICC
FDA UDI
Bard Access Systems, Inc.·00801741028830·Catheter Placement Kit
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964002050·Custom Procedure Kit
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014602837·Schure Strap Brand Rolls, 3"W
1.6 Ah NiCd Battery
FDA UDI
PHYSIO-CONTROL, INC.·00883873980774·LIFEPAK NICD BATTERY ASSY 1.6 AH
SureSmile®
FDA UDI
ORAMETRIX, INC.·00856379007191·Arch wire 16x16 NITI
LIFEPAK CR Plus and LIFEPAK Express defibrillators
FDA UDI
PHYSIO-CONTROL, INC.·00883873820513·PACKAGE,LPCR PLUS,AUTO,ENGLISH,AHA2005, FDA
LIFEPAK® CR Plus and LIFEPAK Express defibrillators
FDA UDI
PHYSIO-CONTROL, INC.·00885074440156·PACKAGE,LPCR PLUS,AUTO,ENGLISH,AHA2005
INSET 30
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·March 30, 2026
MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149
FDA 510(k)
FDA Class 2
·Anesthesiology
AUTOSOFT 30
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V·Product code FPA·April 22, 2025
SJM TAILOR ANNULOPLASTY RING, MODEL TARN
FDA 510(k)
FDA Class 2
·Cardiovascular
SUNI MAX
FDA 510(k)
FDA Class 1
·Dental
IMPLANT: HA 8MM INTEGRAL 3.2
FDA Adverse Event
Injury
·CALCITEK·Product code DZE·October 17, 1996
BIOTRANS™ Pressure Monitoring Kits
FDA UDI
BIOPTIMAL INTERNATIONAL PTE. LTD.·08888893305448·
Quantum
FDA UDI
SPECTRUM MEDICAL LIMITED·05060434423733·Quantum Flow Sensor - ID1/8" x Wall 1/16" (OD1/...
BIOTRANS™ Pressure Monitoring Kits
FDA UDI
BIOPTIMAL INTERNATIONAL PTE. LTD.·08886483501959·
CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 27, 2024
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·May 11, 2021
CS100
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·August 4, 2014