10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment
FDA 510(k)
FDA Class 2
·Dental
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·G586G2423660·deschamps ligature carrier, blunt, left, 8" (20...
MAGIC Infusion Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Puritan OptiTranz Liquid Stuart Collection and Transport System
FDA 510(k)
FDA Class 1
·Microbiology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 2, 2023
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 10, 2011
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 11, 2014
GYNECARE TVT EXACT CONTINENCE SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 23, 2013
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024