19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE
FDA 510(k)
FDA Class 2
·Cardiovascular
CUSTOM PROCEDURE KIT
FDA UDI
MEDIVATORS INC.·40677964006805·The ENDO CARRY-ON Procedure Kit contains all of...
MediClear™ PreOp
FDA UDI
Covalon Technologies Ltd·00825439016169·Antimicrobial Self-Adherent Silicone Film Drape...
Implant Prosthetics
FDA UDI
Preat Corporation·00842092165744·NobelActive™/Conical-compatible NP Engaging Ver...
Thermoflect
FDA UDI
Encompass Group, L.L.C.·00612899004290·THERMOFLECT GOWN KIT D, 25 EA ...
Implant Prosthetics
FDA UDI
Preat Corporation·00842092126165·NobelActive™/Conical-compatible NP Engaging Ver...
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327505238·Standard Tracker and Pointer Insert Tray
HARDYDISK, NALIDIXIC ACID, 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
CARDIOSAVE HYBRID W/ E/F PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·February 24, 2025
UNK XEN STENT
FDA Adverse Event
Injury
·ALLERGAN (IRVINE)·Product code KYF·July 22, 2022
QUALITY ELECTRODYNAMICS
FDA Adverse Event
Malfunction
·QUALITY ELECTRODYNAMICS, LLC·Product code MOS·August 30, 2019
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013
COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 24, 2011
EMBRACE PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·February 18, 2008
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018