11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
REACTIVE DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014607078·SKYTRON 3100 5" SOFTCARE
CSK-TC ELECTRODE
FDA Adverse Event
Malfunction
·COSMAN MEDICAL·Product code GXI·June 6, 2017
BAY AREA HYPERSCIENCES
FDA 510(k)
FDA Class 2
·Anesthesiology
MS-30 LATERAL FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 5, 2024
LIGHTSHEER DUET
FDA Adverse Event
Injury
·LUMENIS, LTD.·Product code GEX·April 26, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 6, 2011
PRISMA CONTROL UNIT
FDA Adverse Event
Other
·GAMBRO DASCO·Product code KDI·July 21, 2008
A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·December 17, 2014
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