9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
FDA 510(k)
FDA Class 2
·Anesthesiology
OXYBOX SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EVOLVE RADIAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
T25 HEXALOBE DRIVER-MALE
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·April 29, 2013
MAXCEM ELITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·May 10, 2011
GE OEC 9800
FDA Adverse Event
Injury
·GE OEC MEDICAL SYSTEM INC.·Product code JAA·July 25, 2008
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025