28 results · 25ms · Sources: EU EUDAMED, US FDA

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AnapnoGuard 100 Respiratory Guard System

FDA 510(k)
FDA Class 2 ·Anesthesiology

HHM

FDA UDI
Oticon A/S·05707131285836·H150V2, RITE 312 WL DBL HHM

APEX Revision Knee

FDA UDI
Omni Life Science, Inc.·00841690111665·Modular Stem 15mm x 75mm

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100080·TEMPORAL SPECULUM OPEN WIRE

Tibial Trial Tray Size 2

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215074074·

MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS

FDA 510(k)
FDA Class 2 ·Ophthalmic

SYSLOC MINI V3

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

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

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 8, 2023

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 29, 2023

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 27, 2023

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

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

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·October 15, 2019

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

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

FRESENIUS 2008H

FDA Adverse Event
Death ·FRESENIUS USA·Product code FII·July 25, 2007

FRESENIUS 2008H

FDA Adverse Event
Other ·FRESENIUS USA·Product code FII·August 8, 2007

UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JGS·February 2, 2010

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

FDA Enforcement
Class II ·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·October 7, 2014

LIGACLIP** ENDOSCOPIC CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 6, 2013