36 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CUSTOM PROCEDURE KIT
FDA UDI
MEDIVATORS INC.·40677964003781·CUSTOM PROCEDURE KIT
Precisor EXL
FDA UDI
Conmed Corporation·30653405051873·Precisor EXL Coated Disposable Biopsy Forceps, ...
Access Dental Lab
FDA UDI
Access Dental Lab, LLC·00850007728182·Power toothbrush replacement head refill 2 pack
LIFEPAK® 500 Automated External Defibrillator
FDA UDI
PHYSIO-CONTROL, INC.·00721902174339·LP500AACAAZZZZZLP500EECGIAAAABAZZZZZ
REICHERT CT200 CONTACT TONOMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
WALLSTENT BILIARY ENDOPROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ZPower Rechargeable System for Hearing Aids
FDA UDI
ZPOWER, LLC·00850034007069·ZPower Rechargeable System for Hearing Aids Kit...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 28, 2023
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 12, 2013
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·February 18, 2011
SIGMA STAB GVF INS 2.5 20MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 19, 2008
DEPTH GAUGE FOR MULTILOC HUM NLING SYS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTJ·April 30, 2025
DRILL SLEEVE / Ø 4.2MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·July 29, 2025
CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code HET·March 8, 2022
BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 3, 2014
Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 5, 2014
BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only). BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 12, 2017
BrightView XCT (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
BrightView XCT
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 22, 2017