14 results
·
31ms
·
Sources: EU EUDAMED, US FDA
CARRIAZO-PENDULAR MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
PELVEX HOMETRAINER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VACUETTE EDTA K2 GEL TUBES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WAVEWRITER ALPHA PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 9, 2023
BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM 24G X 0.75IN.
FDA Adverse Event
Injury
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code FOZ·November 7, 2016
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·April 29, 2013
RESERVOIR 1.8 ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·April 26, 2011
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·July 23, 2008
ANN, BLUNT TIP SCREW, 4X42MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 14, 2022
ANN, BLUNT TIP SCREW, 4X48MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 14, 2022
ANN, PROXIMAL HUMERUS, RIGHT, 11X160MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 14, 2022
ANN, BLUNT TIP SCREW, 4X56MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 14, 2022
ANN, BLUNT TIP SCREW, 4X46MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 14, 2022
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