41 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FEMVUE CORNUAL BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Eclipse Vent Filter Replacement Pack
FDA UDI
BLEEP, LLC·00850003157184·
DEBAKEY VASCULAR CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896002968·DEBAKEY VASCULAR CLAMP ANGLED JAW CURVED SHANK
VOLKMAN RETRACTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896049338·VOLKMAN RETRACTOR SHARP PRONGS
DEBAKEY VASCULAR CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921006620·DEBAKEY VASCULAR CLAMP ANGLED JAW CURVED SHANK
NITANIUM® SUPER ELASTIC ARCHWIRES
FDA UDI
Ortho Organizers, Inc.·00190707059767·.016 X .022 UPPER NITANIUM® SUPER ELASTIC PRO F...
N/A
FDA UDI
Doppkon GmbH & Co. KG·04262494462160·Probe Plastic Handle
D 3.0mm, WL 310mm
Monoblock Tibial Trial PS Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215042653·
RANDOX FERRITIN
FDA 510(k)
FDA Class 2
·Immunology
MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GMK-REVISION 02.07.0312SCF FIXED TIBIAL INSERT SC SIZE 3/12MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 20, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2024
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·May 8, 2013
ENDEAVOR RESOLUTE RX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·September 19, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·May 17, 2011
LATITUDE ELBOW ANATOMIC HUMERAL SPOOL SZ PETIT+ SIDE GAUCHE
FDA Adverse Event
Injury
·TORNIER INC·Product code JDC·May 7, 2024
Brilliance iCT Computed Tomography X-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 30, 2015
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015
Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016
Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018