30 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PowerPICC SOLO
FDA UDI
Bard Access Systems, Inc.·00801741091292·Catheter Placement Kit
Usmile
FDA UDI
Guangzhou Stars Pulse Co., Ltd.·00817277021085·Usmile C10 Portable Dental Flosser
Affiniti
FDA UDI
TORNIER, INC.·00846832022595·LATERAL CUT GUIDE - CUT BLOCK
Halyard
FDA UDI
Avanos Medical, Inc.·10680651349160·On-Q Pain Relief System
TEWA
FDA UDI
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282501303·TeWa 5CB-Type 2030 Speed Pak: coated acupunctu...
TEWA
FDA UDI
asia-med GmbH·04251282508623·TeWa 5CB-Type 2030 Speed Pak: coated acupunctu...
Eclipse Pro
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522131387·ECLIPSE PRO,DEFIB CABLE,PX,4 SNAP,MEDIUM,UKCA
Eclipse Pro
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522129711·ECLIPSE PRO,DEFIB CABLE,PX,4 SNAP,MEDIUM
DIGITAL INFLECTION RIGIDOMETER (DIR)
FDA 510(k)
FDA Unclassified
·Unknown
MODIFICATION TO CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
APC PLUS, CLARITY, MINI UNI-TWIN, VICTORY SERIES
FDA Adverse Event
Injury
·3M UNITEK·Product code DYH·May 9, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·June 16, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·March 12, 2013
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·February 18, 2011
UNK DEPUY FEMORAL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSA·February 19, 2008
UTERINE MANIPULATOR TIP L
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code LKF·September 2, 2022
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