21 results · 38ms · Sources: EU EUDAMED, US FDA

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Astroglide Organix Gel

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777631·LUMBAMED BASIC DORSAL STAYS M SILVER I

PROFYLE

FDA UDI
Stryker GmbH·04546540256041·Drill Guide, L, Eccentric

Accent Buccal Tube

FDA UDI
ORMCO CORPORATION·00889989054293·ORTHOS ACCENT 15DBL UFM -10X22X21 RT

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319706008·Molt (Dingman) Periosteal Elevator #9 - D/E Blu...

TOUCH&BOND-PLUS

FDA 510(k)
FDA Class 2 ·Dental

GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·October 31, 2019

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 12, 2022

T:SLIM X2 INSULIN PUMP

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code LZG·July 30, 2020

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 1, 2024

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·April 18, 2019

COMPOSITCP 30 INTERFERENCE SCREW 9MM X 25MM

FDA Adverse Event
Malfunction ·BIOMET SPORTS MEDICINE, INC.·Product code HWC·August 11, 2011

HOMECHOICE

FDA Adverse Event
Death ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 24, 2014

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 1, 2013

LINER FOR METAL BACK GLENOID STANDARD

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code KWS·November 23, 2020

OT ULTRAMINI METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·June 5, 2012

SPECTRA OPTIA

FDA Adverse Event
Malfunction ·TERUMO BCT·Product code GKT·September 9, 2020

BD INSYTE AUTOGUARD-N STRAIGHT, 24G X 0.56"

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 12, 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