15 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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EASYRA CLINICAL CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ComfortGel Blue
FDA UDI
Respironics, Inc.·00606959015401·ComfortGel Blue Nasal Mask with Headgear, Lab, ...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108699913·Bone Tap for Ø3.75mm Implant
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108690705·Titanium Anatomic Straight Concave Abutment Int...
Zimmer
FDA UDI
Provision·B504TQ6070700570·
RADIONICS LUMBOPERITONEAL SHUNT
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO ARTOSCAN M
FDA 510(k)
FDA Class 2
·Radiology
OMNIGUIDE BEAMPATH FIBER AND ADAPTER
FDA Adverse Event
OMNIGUIDE, INC.·Product code GEX·October 19, 2010
VERCISE GEVIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·March 6, 2024
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·April 22, 2013
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIM·April 26, 2011
TALENT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 3, 2008
2.4MM TI LC-DCP® PLATE 6 HOLES/47MM
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·July 17, 2018
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024