17 results · 20ms · Sources: EU EUDAMED, US FDA

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GlucoSure Link Blood Glucose Monitoring System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SCHWERT

FDA UDI
A. Schweickhardt GmbH & Co. KG·E8962121400·Forceps children's pattern KLEIN upper ...

Ti-Fix OLIF Spacer

FDA UDI
Tyber Medical, LLC·M695P32121400·Ti-Fix OLIF Spacer 32 x 12 x 14 (mm) x 0 °

EXPERIENCE®

FDA UDI
Gc Orthodontics America Inc.·D78821214000101·EXPERIENCE Mini ROTH 022/UR4&5-7T 0A 2D

CADD

FDA UDI
ICU MEDICAL, INC.·10610586034992·

EXPERIENCE®

FDA UDI
Gc Orthodontics America Inc.·D78821214000301·EXPERIENCE Mini XT 022/UR4&5-10T 4A 2D

COM-PATCH

FDA 510(k)
FDA Class 2 ·Neurology

electrocardiograph: SE-1202

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 3, 2021

MENTOR SMOOTH ROUND MODERATE PROFILE

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·September 3, 2019

PRECISION SPECTRA®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 29, 2014

TRANSTAR STRETCHER

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FPO·July 8, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013

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

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

FDA Enforcement
Class II ·Terminated·Philips North America, LLC·March 25, 2020