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