24 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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ABC CERVICAL PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Sledgehammer
FDA UDI
Keystone Industries·H66810004861·SC 5 lb Pwd & 1 Qt Liq Kit, Orig
Affiniti
FDA UDI
TORNIER, INC.·00846832021178·BROACH
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167700004860·
Ultra Vac
FDA UDI
I.C. MEDICAL, INC.·00817688020349·
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167S1700004860·
DATEX-OHMEDA INOVENT DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TUBING SET
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·October 10, 2024
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·March 12, 2013
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 24, 2011
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Injury
·MEDTRONIC SPINE LLC·Product code NDN·February 20, 2008
BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE
FDA Adverse Event
Malfunction
·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026
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
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012
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
BrightView SPECT, Model Number 882480
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 31, 2019