20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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R-Sensor, R-Sensor
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777662·LUMBAMED BASIC DORSAL STAYS M SILVER IV
CoRoent
FDA UDI
Nuvasive, Inc.·00887517568502·CoRoent Ant TLIF Ti, 10x10x28mm 4°
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777617·LUMBAMED BASIC DORSAL STAY WM SILVER IV
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113226·VITRECTOMY KNIFE 20GA (BX/5)
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112694·BARRON CORNEAL PUNCH 9.5MM
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319742570·Ballenger V-Shaped Chisel 6-1/4" (15.6cm), 8mm ...
SCANLAN®
FDA UDI
SCANLAN INTERNATIONAL INC·00846159018530·Dennis Multi-Purpose Clamp
LIQUIBAND ULTIMA, LUT 003
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
T:SLIM X2 INSULIN PUMP
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·June 6, 2018
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 1, 2023
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 14, 2016
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
GLOVE PROTEGRITY MICRO PF LATEX SURG 8.0
FDA Adverse Event
Other
·CARDINAL HEALTH·Product code KGO·October 1, 2008
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 1, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 1, 2016
STAPLE, IMPLANTABLE
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 30, 2017
SYNVISC
FDA Adverse Event
Injury
·GENZYME CORPORATION(RIDGEFIELD)·Product code MOZ·June 23, 2022
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014