18 results · 20ms · Sources: EU EUDAMED, US FDA

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Discovery NM/CT 670 CZT

FDA 510(k)
FDA Class 2 ·Radiology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526768468·GENUMEDI PSS GREEN II

n.a.

FDA UDI
Karl Storz GmbH & Co. KG·04048551057735·BUCK Ear Curette, sharp, size 2

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100318·ALPHONSO INFANT SPECULUM

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100288·SAUER PREMATURE INFANT SPECULUM 2MM

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100363·COOK EYE SPECULUM #2 SOLID

Prime Medical LLC

FDA UDI
Prime Medical LLC·00850055249295·PrimePadPlus-K15-3422

BRK-1

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL CARDIOVASCULAR DIVISION·Product code DRC·February 1, 2024

ELECSYS DHEA-S CALCHECK 5

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SOLOHEALTH STATION

FDA 510(k)
FDA Class 2 ·Cardiovascular

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., HU·Product code KWP·October 17, 2025

CD HORIZON BALLAST SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019

PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

FDA Adverse Event
Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 8, 2013

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·October 8, 2014

ENDOVIVE SAFETY PEG KITS PULL METHOD

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNT·August 21, 2008

PATIENT INFORMATION CENTER IX

FDA Adverse Event
Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 15, 2023

PATIENT INFORMATION CENTER IX

FDA Adverse Event
Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 9, 2023

ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023