21 results · 23ms · 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.

BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17

FDA 510(k)
FDA Unclassified ·Unknown

ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

M2376A DEVICELINK SYSTEM, MODEL M2376A

FDA 510(k)
FDA Class 2 ·Cardiovascular

MINICAP TRANSFER SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·April 22, 2013

ARTICUL/EZE BALL 32 +5 BR

FDA Adverse Event
Injury ·JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.·Product code JDI·April 15, 2011

I-FLOW, ON-Q PAINBUSTER. 270 ML, 5ML/HR

FDA Adverse Event
Injury ·I-FLOW·Product code MEB·July 9, 2008

CAPIOX FX OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·May 22, 2025

CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·December 5, 2022

CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·December 16, 2022

CT EXPRES

FDA Adverse Event
Injury ·BRACCO INJENEERING S.A.·Product code IZQ·September 27, 2023

CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·May 24, 2022

CAPIOX FX05 OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·May 19, 2023

CAPIOX FX25 OXYGENATOR

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 11, 2022

CAPIOX FX25 OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 11, 2022

CAPIOX FX25 OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 29, 2022

CAPIOX FX25 OXYGENATOR

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·February 14, 2022

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

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022