30 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE
FDA 510(k)
FDA Class 2
·Cardiovascular
Nobel
FDA UDI
Preat Corporation·00842092101360·NobelBiocare™ Tri-Lobe-compatible WP Snappy Abu...
Silverbolt/Mainframe
FDA UDI
Choice Spine, LP·10885862161451·
Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®
FDA UDI
I.C. MEDICAL, INC.·00817688024026·Non-Telescopic PenEvac® MaxReveal ™ Diamond Cry...
FlowLogic Assert
FDA UDI
SONENDO, INC.·00810209420949·FlowLogic Assert Shaping File .04 Kit, 21mm
MODIFICATION TO CARTO EP NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·September 15, 2024
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·September 15, 2024
OPTETRAK
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 6, 2019
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·March 12, 2013
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LOM·February 24, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·February 19, 2008
MIX2VIAL
FDA Adverse Event
Malfunction
·WEST PHARMA. SERVICES IL, LTD·Product code LHI·February 13, 2026
Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate - 40 mm, Qty: 1.' The labeling for the screw component reads in part: 'REF: 22-**** MAT'L: Titanium per ASTM F-136 LOT W**** Description: Screw-Fixed Tapping 4x10mm QTY: 1. Manta Ray Anterior Cervical Plate (ACP) System is intended for temporary stabilization of the cervical spine C2-C7 due to the following indications: DDD (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture/dislocation); Tumor; Spinal stenosis; Deformity (i. e. scoliosis, kyphosis and/or lordosis); Pseudoarthrosis; and Failed previous fusion.
FDA Recall
Terminated
·Theken Spine Llc·Product code KWQ·July 29, 2010
Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·October 3, 2018
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, 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