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

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Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

K152468

FDA UDI
Shenzhen Vistar Medical Supplies Co.,Ltd.·96973521874184·Reusable NIBP cuff,Thigh,single tube, HP connector

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 18, 2023

ZOLL PROPAQ MD

FDA 510(k)
FDA Class 2 ·Cardiovascular

THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BINAXNOW COVID-19 TEST

FDA Adverse Event
Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 6, 2022

BINAXNOW COVID-19 ANTIGEN SELF-TEST

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 5, 2022

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 22, 2025

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·October 22, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 27, 2013

UNKNOWN DEPUY ASR HIP

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 15, 2011

RHYTHMIA HDX

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025

Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017

Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014