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OBF MODEL 112 VACUUM CUP SYSTEM

FDA 510(k)
FDA Class 2 ·Ophthalmic

OBF MODEL 115 COMPUTER TONOMETER SYSTEM

FDA 510(k)
FDA Class 2 ·Ophthalmic

LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201

FDA 510(k)
FDA Class 2 ·Ophthalmic

CNS-2101 CENTRAL MONITOR

FDA Adverse Event
Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·March 16, 2026

INFUSO.R.

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 24, 2012

CARESTATION 620

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)·Product code BSZ·April 2, 2020

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FRN·January 26, 2006

BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

FDA Adverse Event
Malfunction ·MEDTRONIC EMERGENCY RESPONSE SYSTEMS·Product code MKJ·August 30, 2006

LIFEPAK 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·MEDTRONIC EMERGENCY RESPONSE SYSTEMS·Product code LDD·August 18, 2006

INFUSO.R. PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·May 5, 2003

LIFEPAK CR PLUS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.·Product code MKJ·February 15, 2006

BIRD

FDA Adverse Event
Malfunction ·VIASYS RESPIRATORY CARE INC·Product code BZR·December 1, 2006

ARCTIC SUN STAT

FDA Adverse Event
Malfunction ·MEDIVANCE, INC. ¿ 1725056·Product code DWJ·July 18, 2024

CNS-6201A

FDA Adverse Event
Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·August 8, 2018

COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD·Product code FRN·August 3, 2004

LIFEPAK 20 DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.·Product code LDD·August 30, 2006

LIFEPAK 20 DEFIBRILLATOR / MONITOR

FDA Adverse Event
Malfunction ·MEDTRONIC EMERGENCY RESPONSE SYSTEMS·Product code LDD·August 30, 2006

BIRD

FDA Adverse Event
Malfunction ·VIASYS RESPIRATORY CARE INC·Product code BZR·October 27, 2006

IVENIX INFUSION SYSTEM

FDA Adverse Event
Malfunction ·FRESENIUS KABI USA LLC·Product code FRN·May 20, 2026

IVENIX INFUSION SYSTEM

FDA Adverse Event
Malfunction ·FRESENIUS KABI USA LLC·Product code FRN·May 19, 2026