9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MapRT
FDA 510(k)
FDA Class 2
·Radiology
ELMED
FDA UDI
ELMED INCORPORATED·00842180175280·ELMED NATHANSON RETRACTOR, 3MM
NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GC TION GINGIVAL PROTECTOR
FDA 510(k)
FDA Class 1
·Dental
PRISM 6 CHANNEL ANALYZER
FDA Adverse Event
Injury
·ABBOTT MANUFACTURING INC·Product code MZA·November 12, 2018
MODIFIED HOLLOW PS TIBIAL INSERT TRIAL #2 - 9MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·November 11, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 12, 2011
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 23, 2013
Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines.
FDA Enforcement
Class II
·Terminated·A M Systems Inc·October 24, 2018