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