17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MedSource Sharps Dart
FDA 510(k)
FDA Class 2
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699557·GENUMEDI PSS BLUE SIZE III
Oticon
FDA UDI
Oticon A/S·05707131286789·H10V2, MINIRITE 312 WL CBE
JMS HARMONY A.V.FISTULA NEEDLE SET
FDA UDI
JMS SINGAPORE PTE LTD·08888483005482·HARMONY A.V.FISTULA 15GX1" BE 40CM W/CLAMP
FIAB SPA, MODELS F7244, F7233, F7234, F7277
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NATURALASE CO2 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LJT·January 7, 2016
INSULIN INFUSION PUMP
FDA Adverse Event
MEDTRONIC MINIMED·Product code OYC·October 7, 2014
11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·June 6, 2013
SGL TRIG WIRE COLLET 0.7-1.8MM
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 7, 2011
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Malfunction
·COOK VASCULAR INC·Product code LJT·January 3, 2019
VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
FDA Adverse Event
Malfunction
·COOK VASCULAR INC·Product code LJT·January 3, 2019
DISPOSABLE STERILE HIGH TEMPERATURE ELECTROCAUTERY (HTC) F7244
FDA Adverse Event
Injury
·FIAB SPA·Product code GEI·October 12, 2023
VITAL-PORT
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code LJT·May 24, 2016
Allura Xper FD20/15; System Code: 722058;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024