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