39 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SALVIN DENTAL SPECIALTIES FIXATION SCREW
FDA 510(k)
FDA Class 2
·Dental
Enamelite
FDA UDI
Keystone Industries·H66851001821·AEROpaque Spray Opaque Shade A1
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317356239·
DEBAKEY VASCULAR FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896081239·DEBAKEY VASCULAR FORCEPS
Tasso-M20
FDA UDI
Tasso Inc.·00860006434540·The Tasso-M20 is used to collect, store, and tr...
VCF PERSONAL LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HARDYDISK TOBRAMYCIN, 10MCG
FDA 510(k)
FDA Class 2
·Microbiology
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 29, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·September 18, 2014
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 16, 2011
SURSHIELD PUR SAFETY I.V. CATHETER
FDA Adverse Event
Injury
·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017
EVOLUT FX PLUS VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025
LMC TIBIAL LINER #5 H14 RIGHT
FDA Adverse Event
Malfunction
·LIMACORPORATE S.P.A.·Product code HRY·July 22, 2022
SOMATOM Confidence -Computed tomography systems Model 10590100
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022
SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 21, 2019
SOMATOM Confidence with software syngo.CT VB20 Model #10590100
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021
CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.
FDA Enforcement
Class II
·Terminated·CSA Medical·January 14, 2015
Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014
HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024