29 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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DIMENSION PENTA L
FDA 510(k)
FDA Class 2
·Dental
Preat
FDA UDI
Preat Corporation·00842092183816·ASC NobelBiocare? Tri-Lobe-compatible RP X 9mm ...
PowerPICC
FDA UDI
Bard Access Systems, Inc.·00801741120855·Catheter Placement Kit
Non-Telescopic PenEvac
FDA UDI
I.C. MEDICAL, INC.·00817688022923·Non-Telescopic PenEvac®, Megadyne E-Z Clean Bla...
BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CRANIAL DRILL
FDA 510(k)
FDA Class 2
·Neurology
OLYMPUS SONOSURG TROCAR XT3900 SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
BD INTEGRA¿ SYRINGE, RETRACTING NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code MEG·December 18, 2017
ROTAFLOW CENTRIFUGAL PUMP SYSTEM
FDA Adverse Event
Death
·MAQUET CARDIOPULMONARY AG·Product code DTQ·October 11, 2016
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·March 12, 2013
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP·Product code FPA·February 2, 2011
9600+
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·February 21, 2008
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
5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, 5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·October 28, 2015
5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm 5.0mm Unit Rod 370mm 5.0mm Unit Rod 390mm 5.0mm Unit Rod 410mm 5.0mm Unit Rod 430mm 5.0mm Unit Rod 450mm pedicle screw spinal system; Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·August 21, 2013
BrightView SPECT (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 SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013
BrightView, Gamma Camera System, Product Code 882480.
FDA Enforcement
Class II
·Ongoing·Philips North America·January 17, 2024
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016
882480: BrightView designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 22, 2017