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

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GammaTile

FDA 510(k)
FDA Class 2 ·Radiology

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306822216·Killian Nasal Speculum, Full Internal Groove, 9...

Cascade IOMAX Intraoperative Monitor

FDA UDI
CADWELL INDUSTRIES, INC.·00840067100653·Cascade IOMAX Cortical Module

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319721292·Buck Ear Curette 6-1/2" (16.3cm), size 5, blunt...

AXIS-SHIELD ANTI-CCP

FDA 510(k)
FDA Class 2 ·Immunology

ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336

FDA 510(k)
FDA Class 2 ·Radiology

ULTRA-THIN SDS BALLOON DILATATION CATHETER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code LIT·October 6, 2008

GYNECARE TVT SECUR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code PAH·June 26, 2013

GENERIC - CELSIUS II BI-DIRECTIONAL TC

FDA Adverse Event
Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DRF·August 4, 2011

Cascade IOMAX Cortical Module, REF: 190296-200

FDA Recall
Open, Classified ·Cadwell Industries Inc·Product code GWF·April 23, 2024

Cascade IOMAX Cortical Module, REF: 190296-200

FDA Recall
Open, Classified ·Cadwell Industries Inc·Product code GWF·May 17, 2024

Cascade IOMAX Cortical Module, REF: 190296-200

FDA Enforcement
Class II ·Ongoing·Cadwell Industries Inc·July 24, 2024

Cascade IOMAX Cortical Module, REF: 190296-200

FDA Enforcement
Class II ·Ongoing·Cadwell Industries Inc·May 29, 2024

HEARTMATE 3 VAD MODULAR CABLE

FDA Adverse Event
Malfunction ·THORATEC CORPORATION·Product code DSQ·April 30, 2021

HEARTMATE 3 VAD MODULAR CABLE

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·February 4, 2019

THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

FDA Adverse Event
Malfunction ·THORATEC CORPORATION·Product code DSQ·December 15, 2023