15 results · 21ms · Sources: EU EUDAMED, US FDA

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'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

GRADIA®

FDA UDI
Gc America Inc.·D0470019781·GRADIA® DIRECT Unitips: 10 tips 0.16 mL B3

GRADIA®

FDA UDI
Gc America Inc.·14548161073608·GRADIA® DIRECT Unitips: 10 tips 0.16 mL B3

D-Series Size 1.5 Posterior LIME Bite Block 3-Pack

FDA UDI
CLIKTECH LLC·00856200001978·D-Series Size 1.5 Posterior LIME Bite Block 3-Pack

BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 20, 2017

ANATOMIC TOTAL KNEE PROSTHESIS

FDA 510(k)
FDA Class 2 ·Orthopedic

SULZER ORTHOPEDICS MS-30 FEMORAL STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

TUFF IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·May 23, 2026

CARDIOSAVE HYBRID, TYPE B PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·April 1, 2026

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·March 13, 2013

COULTER LH 750 ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code LOQ·February 27, 2011

ULTRASOFT LANCING DEV

FDA Adverse Event
Injury ·LIFESCAN, INC.·Product code FMK·February 21, 2008

ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

FDA Enforcement
Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012