19 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AMCOM COMMTECH MESSENGER
FDA 510(k)
FDA Class 2
·Cardiovascular
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017705·K-Wire, Double Ended, Trocar Point, Diameter Si...
BioCare Safety Needles
FDA UDI
BIOTRONIX HEALTHCARE INDUSTRIES, INC.·00858835007776·Disposable BioGuard Safety Needles 23G x 1 1/2"
Marker Pin Smooth
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215068615·
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857242234·Tapered Double Ended Driver Size 15
3I CALCIUM SULFATE BONE CEMENT
FDA 510(k)
FDA Class 2
·Dental
LCI OPTION FOR INNOCOR
FDA 510(k)
FDA Class 2
·Anesthesiology
RIVA STAR SILVER DIAMINE FLUORIDE
FDA Adverse Event
Injury
·SDI LIMITED·Product code LBH·February 13, 2019
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·May 19, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·April 1, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·January 16, 2023
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·March 1, 2023
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 7, 2022
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 14, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·June 2, 2011
VANTEX CENTRAL VENOUS CATHETHER WITH OLIGON MATERIAL WITH OR
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code FOZ·August 4, 2008
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·June 14, 2022
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021