15 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
KMC KYPHOPLASTY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
7930 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136021713·7930-40 MED/SM M/F MASK w/2730
Stablecut®
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024494169·
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642105148·PS3 Screw 7.5mm x 40mm
Stablecut®
FDA UDI
SYNVASIVE TECHNOLOGY, INC.·00846795011254·
Medetz Surgical Instruments
FDA UDI
Medetz Surgical Instruments LLC·G2231137420·Bunge Evisceration Spoon, small, OL 135mm (5 1/...
ONESTEP ADULT MULTI-FUNCTION ELECTRODE
FDA 510(k)
FDA Class 3
·Cardiovascular
ACCELL EVO3 (FORMERLY ACCELL A2I)
FDA 510(k)
FDA Class 2
·Orthopedic
PELVILACE TO BIOURETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·May 10, 2013
VIPER MIS CANNULATED X-TAB SCREW
FDA Adverse Event
Injury
·DEPUY SYNTHES SPINE·Product code NKB·September 24, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 2, 2011
TFNA HELICAL BLADE L80 TAN
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HSB·July 18, 2017
AFX
FDA Adverse Event
Injury
·ENDOLOGIX, INC.·Product code MIH·November 16, 2015
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 6, 2023
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025