18 results · 39ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR)

FDA 510(k)
FDA Class 1 ·General Hospital

SALUTE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SOMATOM P30 CT SYSTEMS

FDA 510(k)
FDA Class 2 ·Radiology

SYSTEM 98XT, ENGLISH, 110V

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·February 3, 2026

SYSTEM 98XT

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·September 22, 2025

ASSY,ENGLISH,DOMSTC,110V,SYS98

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·December 26, 2025

CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·November 3, 2025

CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·November 18, 2025

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 17, 2013

CONCERTO CRT-D DR

FDA Adverse Event
Death ·MEDTRONIC MED REL, INC.·Product code NIK·April 19, 2011

AXSYM RUBELLA IGG ANTIBODY

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code LFX·June 19, 2008

CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·January 14, 2026

ASSY,ENGLISH,DOMSTC,110V,SYS98

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·September 15, 2025

E-LUMINEXX BILIARY STENT

FDA Adverse Event
Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code FGE·November 17, 2015

E-LUMINEXX BILIARY STENT

FDA Adverse Event
Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code FGE·August 16, 2016

SENSATION 7FR. 34CC IAB

FDA Adverse Event
Death ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 2, 2021

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015