10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
BROACH, FEMORAL, ACTERA, SIZE 00
FDA UDI
Conformis, Inc.·00810933031435·BROACH, FEMORAL, ACTERA FEMORAL BROACH SIZE 00
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481476545·
ENSIL FABRIC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 7, 2025
GLUMA DESENSITIZER
FDA Adverse Event
Injury
·HERAEUS KULZER GMBH·Product code KLE·April 12, 2013
TRABECULAR METAL FEMORAL STEM PRESS-FIT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code LPH·April 26, 2011
STERLING OVER-THE-WIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·July 22, 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