25 results · 22ms · Sources: EU EUDAMED, US FDA

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FUBUKI XF-R Neurovascular Long Sheath

FDA 510(k)
FDA Class 2 ·Cardiovascular

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776209230·NEEDLE HDER STRAIGHT TUNG

ELMED

FDA UDI
ELMED INCORPORATED·00842180188150·5 MM DIA., 45 CM, NEEDLE HOLDER STRAIGHT TUNGST...

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668101261·SWISS MODEL BLADE BREAKER

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197172356·Vannas Adventitia Scissor straig...

QuickPlan

FDA 510(k)
FDA Class 2 ·Radiology

NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR

FDA 510(k)
FDA Class 2 ·Neurology

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·October 30, 2024

HEARTSTART MRX-EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 3, 2014

BIVONA CUSTOM TRACHEOSTOMY TUBE

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·August 26, 2011

DLT TS CER HD 12/14 36MM +5.0

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LZO·July 29, 2013

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·July 23, 2025

AIRVO TUBE AND CHAMBER KIT WITH NEBULISER ADAPTOR

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·October 29, 2024

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·April 8, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·April 9, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·February 11, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAF·March 31, 2026