18 results · 25ms · Sources: EU EUDAMED, 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