12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
FDA 510(k)
FDA Class 2
·Anesthesiology
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5820804840·RONGEUR
Regent
FDA UDI
SPINAL ELEMENTS·00840916115067·Regent ACP 4-Level, 84mm
A&E Medical / Rotating Surgical Punches
FDA UDI
A & E MEDICAL CORPORATION·20841291107122·4.8 Rotating Surgical Punch, Tapered, Non-Steri...
SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
CARESIDE LDH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STAYFUSE
FDA Adverse Event
Other
·NEXA ORTHOPEDICS, INC.·Product code HSB·August 21, 2007
BASIS¿ SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC·Product code KWP·July 19, 2012
5.0MM FLEXIBLE SHAFT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTO·April 26, 2013
SINGLE EXTENSION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 22, 2011
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·July 21, 2008
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