8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Secret Pro
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
FDA 510(k)
FDA Class 2
·Radiology
STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IMP,TSV,4.1MM,SBM,10
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·July 10, 2024
V200 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·November 6, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 2, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 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