17 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cardinal HealthTM Poly-Coated Open-Back Protective Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100981·DESMARRES LID RETRACTOR #3
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A182830150·18mm H x 28mm W x 30mm L x 15 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A18283080·18mm H x 28mm W x 30mm L x 8 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A182830120·18mm H x 28mm W x 30mm L x 12 degrees ALIF
MUSTMINI OCCIPITAL SCREW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025
ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
INFX-8000H, INFINIX-I
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DRY·July 8, 2011
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 11, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 17, 2014
Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.
FDA Enforcement
Class II
·Terminated·Intersurgical Inc·January 15, 2020
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026
INTROCAN SAFETY® 3
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025
MUSTMINI OCCIPITAL SCREW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025
MUST MINI OC PRE-BENT TRANSITION ROD 75° Ø3.5/4X 200MM (STE)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKG·April 25, 2024