57 results
·
23ms
·
Sources: EU EUDAMED, US FDA
ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316
FDA 510(k)
FDA Class 2
·Immunology
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00012961·
PowerPICC
FDA UDI
Bard Access Systems, Inc.·00801741028847·Catheter Placement Kit
CONMED
FDA UDI
Conmed Corporation·10653405051077·CONMED Adult Gastroscope Sheathed Cytology Brus...
GC Fuji II LC®
FDA UDI
Gc America Inc.·D0470001961·GC Fuji II LC® A2, 15 g powder btl
GC Fuji II LC®
FDA UDI
Gc America Inc.·14548161282420·GC Fuji II LC® A2, 15 g powder btl
GentleYAG Delivery System CPO
FDA UDI
Candela Corporation·00817495020655·Delivery System Assembly
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Unimed
FDA UDI
Unimed Medical Supplies, Inc.·06945664895620·Disposable SpO2 Probe/Adhesive/Nellcor/Adult+Ne...
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·March 31, 2023
RADOVAN TISSUE EXPANDER, 700 CC
FDA Adverse Event
MENTOR CORP.·Product code LCJ·December 21, 1993
HIGH PROFILE, 400 CC
FDA Adverse Event
MCGHAN MEDICAL CORP.·Product code FTR·December 21, 1993
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·June 9, 2021
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·June 9, 2021
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·May 18, 2021
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·May 18, 2021
LUMIRADX SARS-COV-2 AG TEST STRIP KIT
FDA Adverse Event
Malfunction
·LUMIRADX UK LTD.·Product code QKP·May 18, 2021
CARDIOSAVE HYBRID, TYPE G PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·July 18, 2024
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·November 13, 2024