14 results
·
18ms
·
Sources: EU EUDAMED, US FDA
LCCS VC-S RF Cannula
FDA 510(k)
FDA Class 2
·Neurology
Bernafon
FDA UDI
Bernafon AG·05711584086278·ZR3 MNR, 2.4G NFM PB MSIL ZERENA 3
Hysteroscopy obturator
FDA UDI
SOPRO-COMEG GmbH·04059082006529·
Hysteroscopy obturator
FDA UDI
SOPRO-COMEG GmbH·04059082032603·
Hysteroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082006536·
Hysteroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082032610·
SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)
FDA 510(k)
FDA Class 1
·General Hospital
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·November 26, 2019
ROTAREXS 8F 110CM (STRAUB MEDICAL)
FDA Adverse Event
Malfunction
·STRAUB MEDICAL AG·Product code MCW·July 4, 2020
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·October 9, 2008
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·June 26, 2013
OMNILINK ELITE PERIPHERAL STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIO·August 4, 2011
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018