29 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES RAPID RESORBABLE TACK SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704505900·
LOCATOR F-Tx
FDA UDI
Zest Anchors, LLC·00840481121135·LOCATOR F-Tx Abutment For Wide Platform (WP) In...
SILVERVENT
FDA UDI
Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948003185·SILVERVENT 1 IC + 1 ICU, SIZE 4
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481110641·LOCATOR R-Tx Abutment for Wide Platform (WP) In...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450140147·
Pro-Tec
FDA UDI
Dectro International·00686209052042·Hair-removal electrolysis probe, single-use
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481128813·LOCATOR R-Tx Abutment, Wide Platform (WP) Tri-c...
TLS 5.0
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B0301000502040·Rotating Scraper, QC, IBFD, 11mm
STRYKER NAVIGATION SYSTEM-KNEE MODULE
FDA 510(k)
FDA Class 2
·Neurology
WIN-1 TANGO
FDA 510(k)
FDA Class 2
·Physical Medicine
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 3, 2025
Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013
SUREFLEX LITHOTRIPSY FIBER
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·April 5, 2013
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code KRH·May 21, 2008
PULSE GEN MODEL 103
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·April 1, 2011
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 16, 2024
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 1, 2024
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025