16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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