34 results · 25ms · Sources: EU EUDAMED, 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