18 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BeamSite
FDA 510(k)
FDA Class 2
·Radiology
Bernafon
FDA UDI
Bernafon AG·05711584114650·CO7 MNR T, 2.4G NFM SABE DEMO CAPTO 7 GPL
Richard-Allan® Needle 1/2 Circle Taper
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00840113216949·Intent to be used with suture material for tiss...
VERIDIAN
FDA UDI
VERIDIAN HEALTHCARE LLC·00845717000437·ProKit Aneroid Sphygmomanometer With Sprague Sc...
BioHorizons
FDA UDI
BIOHORIZONS IMPLANT SYSTEMS, INC·00847236002145·External 6.0mm x 6mm Flared Healing Abutment
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383515047·"An absorbent paper points is an endodontic pap...
BD SYRINGE LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 13, 2018
Spartan Calcar Planer Blade
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215114916·
CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE
FDA 510(k)
FDA Class 2
·Cardiovascular
ACTIVATOR V-E
FDA 510(k)
FDA Unclassified
·Unknown
ESTEEM
FDA Adverse Event
Malfunction
·ENVOY MEDICAL·Product code OAF·January 16, 2015
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·October 24, 2008
OCTRODE 60-CM LENGTH PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 11, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
AXIUM PRIME BRPL 3D
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·November 1, 2022
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
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021