11 results · 30ms · Sources: EU EUDAMED, US FDA

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White Nitrile Powder Free Patient Examination Glove, Non Sterile

FDA 510(k)
FDA Class 1 ·General Hospital

VEO® Lateral Interbody Fusion System

FDA UDI
Choice Spine, LP·00840996133951·LATERAL,ANGLED RASP WELDMENT,TWO SIDED

BIOCELLECT

FDA 510(k)
FDA Class 2 ·Dental

ELECTRONIC SPHYGMOMANOMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 29, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

FORTIFY ASSURA VR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013

TRINITY

FDA Adverse Event
Injury ·CORIN LTD (UK & FR)·Product code MEH·February 28, 2023

TRINITY

FDA Adverse Event
Injury ·CORIN LTD·Product code LZO·December 13, 2022

ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system 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.·August 5, 2015