34 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIMENSION GARANT L, DIMENSION GARANT L QUICK
FDA 510(k)
FDA Class 2
·Dental
PowerPICC
FDA UDI
Bard Access Systems, Inc.·00801741128264·Catheter Placement Kit
PenEvac1
FDA UDI
I.C. MEDICAL, INC.·00817688022763·PenEvac1®, Stainless Steel Blade, 10’ Tube, Uni...
CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REICHERT CT200 CONTACT TONOMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·August 9, 2024
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·January 27, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 2, 2025
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·September 2, 2022
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·July 5, 2023
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·March 21, 2023
CARDIOSAVE HYBRID TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·January 30, 2023
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·January 25, 2023
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·October 11, 2022
CARDIOSAVE RESCUE
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·October 18, 2022
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·December 27, 2016
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·March 12, 2013
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC·Product code CBK·February 1, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC·Product code JAA·February 21, 2008
Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·October 3, 2018