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Data / Medical devices / United States / Zien Medical Technologies LLC

Zien Medical Technologies LLC: FDA-registered device maker in Salt Lake City, UT, United States, 17 510(k) clearances

Zien Medical Technologies LLC is registered with the FDA (registration 3009756153) in Salt Lake City, UT, United States. It lists 49 device types. The FDA files 17 510(k) clearances under its listings, the newest dated March 24, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Zien Medical Technologies LLC
FDA registration number
3009756153
Address
2490 South 300 West, Salt Lake City, UT, United States, 84115
Owner or operator
Zien Medical Technologies LLC (10047676)
Roles
Contract manufacturer, Manufacturer, Specification developer
First device listed
February 6, 2015
Registered through
2026
Brand names listed
ARX-LP6/ASPIRE RX-LP6 ASPIRATION CATHETER 136CM, ASPIRE Mechanical Thrombectomy Aspirator/Drive Unit/Pump; ASPIRE RX-LP Rapid Exchange Mechanical Thrombectomy System, Accessories, Arthroscopic, Arthroscope, Bone File, CATS Tonometer Prism, CATS-D Tonometer Prism, CATS-L and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Contract manufactureraccessdata.fda.gov
ArthroscopeHRX2Contract manufactureraccessdata.fda.gov
Aspiration Thrombectomy CatheterQEZ2Manufactureraccessdata.fda.gov
Cable, ElectrodeIKD2Contract manufactureraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Manufactureraccessdata.fda.gov
Catheter Introducer KitOFC2Manufactureraccessdata.fda.gov
Catheter, Continuous FlushKRA2Manufactureraccessdata.fda.gov
Catheter, Intravascular Occluding, TemporaryMJN2Manufactureraccessdata.fda.gov
Catheter, PercutaneousDQY2Manufactureraccessdata.fda.gov
Catheter, Percutaneous, Cutting/ScoringPNO2Manufactureraccessdata.fda.gov
Catheter, Peripheral, AtherectomyMCW2Contract manufactureraccessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical UseJQC1Contract manufactureraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Contract manufactureraccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Contract manufacturer, Manufactureraccessdata.fda.gov
Device, Irrigation, Ocular SurgeryKYG1Manufactureraccessdata.fda.gov
Endoscope, FlexibleGCQ2Contract manufactureraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Manufactureraccessdata.fda.gov
FileHTP1Contract manufactureraccessdata.fda.gov
File, Bone, SurgicalEMI1Contract manufactureraccessdata.fda.gov
ForcepsHTD1Contract manufactureraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Contract manufactureraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Manufactureraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufactureraccessdata.fda.gov
Knife, OrthopedicHTS1Contract manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Contract manufactureraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Contract manufactureraccessdata.fda.gov
Laryngoscope, RigidCCW1Manufactureraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Contract manufactureraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Contract manufacturer, Manufactureraccessdata.fda.gov
Percutaneous Introducer KitPXB2Manufactureraccessdata.fda.gov
Platelet And Plasma Separator For Bone Graft HandlingORG2Contract manufactureraccessdata.fda.gov
ProbeHXB1Contract manufactureraccessdata.fda.gov
RongeurHTX1Contract manufactureraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Contract manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufactureraccessdata.fda.gov
Stethoscope, ElectronicDQD2Specification developeraccessdata.fda.gov
Surgical Eye TrayPZG1Manufactureraccessdata.fda.gov
Syringe, PistonFMF2Manufactureraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Contract manufactureraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Contract manufactureraccessdata.fda.gov
TemplateHWT1Contract manufactureraccessdata.fda.gov
Tonometer, ManualHKY2Manufacturer, Specification developeraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Contract manufactureraccessdata.fda.gov
Tray, SurgicalLRP1Contract manufactureraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Manufactureraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Contract manufactureraccessdata.fda.gov
Washer, Bolt NutHTN2Contract manufactureraccessdata.fda.gov
Wire, Guide, CatheterDQX2Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 24, 2025K250013VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)QEZSubstantially EquivalentControl Medical Technology, Inc. / Dba Ventiv Scientificaccessdata.fda.gov
July 2, 2024K240915ZIEN IO Intraosseous Access SystemFMISubstantially EquivalentZien Medical Technologies, Inc.accessdata.fda.gov
June 17, 2024K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterPNOSubstantially EquivalentTransit Scientific, LLCaccessdata.fda.gov
February 9, 2024K234037CATS-L Tonometer™ PrismHKYSubstantially EquivalentCats Tonometer, LLCaccessdata.fda.gov
November 29, 2023K231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)KRASubstantially EquivalentTransit Scientific, LLCaccessdata.fda.gov
September 19, 2022K214060LANDMARK REBOA CatheterMJNSubstantially EquivalentZien Medical Technologies, Inc.accessdata.fda.gov
October 21, 2021K210322XO Cross Support CatheterDQYSubstantially EquivalentTransit Scientific, LLCaccessdata.fda.gov
August 4, 2021K211068PrevisEA DeviceDQDSubstantially EquivalentEntac Medical, Inc.accessdata.fda.gov
June 14, 2021K203850CATS®-D Tonometer PrismHKYSubstantially EquivalentCats Tonometer, LLCaccessdata.fda.gov
May 29, 2020K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterPNOSubstantially EquivalentTransit Scientificaccessdata.fda.gov
May 6, 2020K193420XO Cross Support CatheterDQYSubstantially EquivalentTransit Scientificaccessdata.fda.gov
May 4, 2020K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorQEZSubstantially EquivalentControl Medical Technologyaccessdata.fda.gov
March 9, 2018K173904CATS Tonometer PrismHKYSubstantially EquivalentCats Tonometer, LLCaccessdata.fda.gov
December 10, 2014K141054DISTAL ACCESS TORQUE DEVICEDQXSubstantially EquivalentDistal Access, LLCaccessdata.fda.gov
November 26, 2013K131998ASPIRE RX-LP6 ASPIRATION CATHETERQEZSubstantially EquivalentControl Medical Technology, LLCaccessdata.fda.gov
February 22, 2012K113757ASPIRE MAX ASPIRATION CATHETERQEZSubstantially EquivalentControl Medical Technology, LLCaccessdata.fda.gov
October 4, 2007K072299POWRSYRINGE ASPIRATORFMFSubstantially EquivalentPinyons Medical Technology, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
August 18, 201572038Class IITerminatedPenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from September 2014-July 2015. This led to the decision to recall the product.accessdata.fda.gov

Compare with other makers

Updated March 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.