24 results · 23ms · 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.

OPTIBAND LC

FDA 510(k)
FDA Class 2 ·Dental

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032407·Baltic Denture System BDLoad ↓ Lw6 PLSEum4DFl B...

ICU Medical

FDA UDI
ICU MEDICAL, INC.·00840619060008·TriOx™ SvO2 PA Catheter P7110-EH, 7.5F, 110cm, ...

ICU Medical

FDA UDI
ICU MEDICAL, INC.·00840619085957·Opticath Catheter P7110-EH, 7.5F, 110 cm, Hepar...

Octane Straight

FDA UDI
Choice Spine, LP·10885862237781·

Octane Straight PC

FDA UDI
Choice Spine, LP·10885862278210·

PACEART TX3 CARDIAC EVENT RECORDER

FDA 510(k)
FDA Class 2 ·Cardiovascular

EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SMART MONITOR 2 PS

FDA Adverse Event
Malfunction ·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 6, 2025

NATURALYTE

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 1, 2013

PULSE GEN MODEL 102

FDA Adverse Event
Injury ·CYBERONICS, INC.·Product code LYJ·March 28, 2011

LIFEPAK 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·April 17, 2008

ARCHITECT ANTI-TPO

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·September 11, 2025

ALINITY I ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·December 10, 2025

SMART MONITOR 2 PS

FDA Adverse Event
Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013

ALINITY I ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·December 10, 2025

ALINITY I ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·September 16, 2025

ARCHITECT ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JZO·May 23, 2025

ALINITY I ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·March 17, 2025