20 results · 22ms · Sources: EU EUDAMED, 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