18 results · 27ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

AirSeal iFS System; AirSeal dV Solution

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

MEGATECH SCIENTIFIC FACE MASK

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Astroglide Organix Gel

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

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 15, 2023

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 7, 2022

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 1, 2022

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 20, 2023

RELION MICRO BLOOD GLUCOSE SYSTEM

FDA Adverse Event
Malfunction ·ARKRAY, INC.·Product code CGA·June 10, 2011

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 14, 2022

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 5, 2023

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·January 26, 2021

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 17, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·July 16, 2013

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·April 9, 2020

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·September 6, 2019

PRODIGY AUTOCODE

FDA Adverse Event
Injury ·OK BIOTECH CO., LTD.·Product code NBW·September 20, 2019

ACCOLADE DR SL MRI (Model L311)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025