15 results · 19ms · Sources: EU EUDAMED, US FDA

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RYTHMIC AND RYTHMIC UV

FDA 510(k)
FDA Class 2 ·Ophthalmic

EndoGator Hybrid

FDA UDI
MEDIVATORS INC.·00724995224172·EndoGator Tubing Hybrid, Pentax is used with EN...

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114018·HYDRO-DISSECT FLAT J 25GA (PK/10)

SCANLAN® Needle Holders

FDA UDI
SCANLAN INTERNATIONAL INC·00846159008692·Jacobson Micro Needle Holder Round Handle

ORTHO SUMMIT SAMPLE HANDLING SYSTEM

FDA Adverse Event
Malfunction ·HAMILTON BONADUZ AG·Product code JTC·July 13, 2000

GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/23MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 22, 2021

ACCUSONIC PLUS, MODEL AP-100

FDA 510(k)
FDA Class 2 ·Physical Medicine

SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

HEARTSTART MRX - EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 26, 2014

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code MDS·February 18, 2011

EVOLUT FX DCS

FDA Adverse Event
Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025

bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024