17 results · 22ms · Sources: EU EUDAMED, 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