10 results · 19ms · 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.

ZinRom Nitrile examination gloves

FDA 510(k)
FDA Class 1 ·General Hospital

BELIFU

FDA Adverse Event
Injury ·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020

PLUS CANCELLOUS BONE SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

OASYS SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

PUMP MMT-522NAP PRDGM INS V2.2 PL EN

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code LZG·October 23, 2008

ASR 300 SPIKED CUP SIZE 52

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011

GYNECARE TVT SECUR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code PAH·July 8, 2013

PERITONEAL CATHETER

FDA Adverse Event
Injury ·COVIDIEN MFG SOLUTIONS S.A.·Product code FJS·May 19, 2021

18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017