20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NeoFuse Ti3D PLIF/TLIF
FDA UDI
XENIX MEDICAL LLC·00818345021655·Ti3D CAGE 24L x 12W x 13H
NeoFuse HA Enhanced PLIF/TLIF
FDA UDI
XENIX MEDICAL LLC·00818345020573·HA CAGE 24L x 12W x 13H
HUDSON RCI
FDA UDI
TELEFLEX INCORPORATED·14026704343987·Comfort Flo Plus Cannula with Chin Strap
HUDSON RCI
FDA UDI
TELEFLEX INCORPORATED·14026704743626·Comfort Flo Plus Cannula with Chin Strap
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377021268·Perfect Fit Effort Belt, Interface Cable, Adult
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377021275·Perfect Fit Effort Belt, Interface Cable, Pedia...
AMERIWATER OZONE DISINFECTION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
3DSCOPE
FDA 510(k)
FDA Class 2
·Radiology
HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-S
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAT·July 26, 2016
HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-S
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAT·July 26, 2016
HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-S
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAT·July 26, 2016
HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-M
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAT·January 6, 2017
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 9, 2011
MITEK EXPRESSEW II FLEXIBLE SUTURE PASSER
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code LXH·July 22, 2013
HUDSON COMFORT FLO PLUS CANNULA W/CHIN STRAP-M
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAT·January 30, 2017
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES - WSO, Omni PET Gantry 15cm Mobile WSO, Omni PET Gantry 21cm - WSO, Omni PET Gantry 21cm Mobile - WSO, OMNI PET Gantry 30cm, Omni PET Gantry 30cm - WSO; System, Tomography, Computed, Emission
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 28, 2026
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014