13 results · 21ms · 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.

TARGETSCAN BIOPSY KIT

FDA 510(k)
FDA Class 2 ·Radiology

O-RING PROSTHETIC ATTACHMENT

FDA 510(k)
FDA Class 2 ·Dental

ILT ADVANCING MECHANISM, MODEL A115AMI

FDA 510(k)
FDA Class 2 ·Cardiovascular

NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·April 15, 2024

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code MEB·August 23, 2021

CE INFUSOR LV 2, 12 PACK

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 14, 2010

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Death ·BAXTER HEALTHCARE·Product code KDJ·April 8, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·March 10, 2011

FLEXTEND IS-1 BI POSITIVE FIX 45CM

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

CE INFUSOR SV 2, 12 PACK

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 10, 2010

Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

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

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018