58 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Soundly Anti Snoring Device
FDA 510(k)
FDA Class 2
·Dental
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00842180135437·3 MM DIA., 30 CM MICRO TIP BIOPOLAR FORCEPS, SP...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306824517·Walther Female Dilator-Catheters 13cm, 30Fr
Vercise™ Cartesia™ X
FDA UDI
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·08714729966333·Directional Lead Kit, 16 Contact, 30cm
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
FDA 510(k)
FDA Class 2
·Neurology
DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS)
FDA 510(k)
FDA Class 2
·Anesthesiology
ONE TOUCH BASIC
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·March 22, 2002
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 29, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 1, 2022
T:SLIM G4 SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code OYC·October 7, 2017
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·July 8, 2018
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·March 15, 2018
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·February 21, 2018
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·April 12, 2019
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·March 15, 2018
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·August 6, 2019
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·November 22, 2019
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·August 23, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Death
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·November 4, 2008
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013