Skip to the page
Get started – free

Data / Medical devices / United States / Hosmed Inc.

Hosmed Inc.: FDA-registered device maker in Doral, FL, United States, 25 510(k) clearances

Hosmed Inc. is registered with the FDA (registration 3007836437) in Doral, FL, United States. It lists 46 device types. The FDA files 25 510(k) clearances under its listings, the newest dated January 7, 2022. 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 Hosmed Inc.
FDA registration number
3007836437
Address
3403 NW 82nd Avenue Suite 102E, Doral, FL, United States, 33122
Owner or operator
Hosmed Inc (10037002)
Roles
Manufacturer, Repackager or relabeler
First device listed
July 5, 2013
Registered through
2026
Brand names listed
BSC 12 Patient Monitor, BSC 15 Patient Monitor, Bipolar Pacing Catheter, Capri Table Top Pulse Oximeter, Challenger 5200 Mobile X-Ray Equipment, Cruise PTCA Balloon Catheter, Disposable Catheter, Dosglide PVC Infusion Gravity Set , 20 drps/ml, 150 cm, DEHP Free, Latex Free, Needless Port and more

Devices it lists

DeviceProduct codeClassRoleSource
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL2Repackager or relabeleraccessdata.fda.gov
Alarm, Blood-PressureDSJ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)NHO2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)CBQ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)CBS2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)NHQ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)CBR2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-PhaseCCL2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)NHP2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bed, Ac-Powered Adjustable HospitalFNL2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bed, ManualFNJ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Blood Pressure CuffDXQ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cabinet, Table And Tray, AnesthesiaBRY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Camera, Cine, Endoscopic, Without AudioFWL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter, Hemodialysis, Non-ImplantedMPB2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter, Intravascular, DiagnosticDQO2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Catheters, Transluminal Coronary Angioplasty, PercutaneousLOX2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Computer, Blood-PressureDSK2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-FunctionDXG2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Detector And Alarm, ArrhythmiaDSI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
ElectrocardiographDPS2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Electrode, CutaneousGXY2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Index-Generating Electroencephalograph SoftwareOLW2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Lamp, SurgicalFTD2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Mask, ScavengingKHA1Repackager or relabeleraccessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Monitor, St Segment With AlarmMLD2Manufacturer, Repackager or relabeleraccessdata.fda.gov
OximeterDQA2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Plethysmograph, ImpedanceDSB2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Set, Administration, IntravascularFPA2Repackager or relabeleraccessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)MQB2Repackager or relabeleraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Stretcher, WheeledFPO2Manufacturer, Repackager or relabeleraccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Manufacturer, Repackager or relabeleraccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Manufacturer, Repackager or relabeleraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Manufacturer, Repackager or relabeleraccessdata.fda.gov
System, X-Ray, MobileIZL2Repackager or relabeleraccessdata.fda.gov
Table And Attachments, Operating-RoomBWN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Table, Operating-Room, Ac-PoweredFQO1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Transducer, Blood-Pressure, ExtravascularDRS2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Manufacturer, Repackager or relabeleraccessdata.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
January 7, 2022K211349Selebrek PTCA Balloon Dilatation CatheterLOXSubstantially EquivalentKossel Medtech (Suzhou) Co., Ltd.accessdata.fda.gov
August 25, 2021K212134Diagnostic X-ray System/PLX5200AIZLSubstantially EquivalentNanjing Perlove Medical Equipment Co., Ltd.accessdata.fda.gov
July 23, 2021K202060Disposable IV catheterFOZSubstantially EquivalentShinva Ande Healthcare Apparatus Co., Ltd.accessdata.fda.gov
July 2, 2021K211393Selethru(TM) NC PTCA Balloon Dilatation CatheterLOXSubstantially EquivalentKossel Medtech (Suzhou) Co., Ltd.accessdata.fda.gov
December 31, 2019K192343Patient MonitorDQASubstantially EquivalentShenzhen Creative Industry Co., Ltd.accessdata.fda.gov
December 13, 2019K191106C50 and C80 Multi-parameter Patient MonitorMHXSubstantially EquivalentShenzhen Comen Medical Instruments Co.,Ltdaccessdata.fda.gov
August 17, 2018K180974CBit Series Digital Color Doppler Ultrasound SystemIYNSubstantially EquivalentCHISON Medical Technologies Co., Ltd.accessdata.fda.gov
June 6, 2017K170374SonoBook Series Diagnostic Ultrasound SystemIYNSubstantially EquivalentChison Medical Imaging Co., Ltd.accessdata.fda.gov
May 31, 2017K162601Infusion Set for Single UseFPASubstantially EquivalentShinva Ande Healthcare Apparatus Co., Ltd.accessdata.fda.gov
September 14, 2016K162172EBit Series Diagnostic Ultrasound SystemIYNSubstantially EquivalentChison Medical Imaging Co., Ltd.accessdata.fda.gov
July 28, 2015K150861QBit Series Diagnostic Ultrasound SystemIYNSubstantially EquivalentChison Medical Imaging Co., Ltd.accessdata.fda.gov
June 2, 2014K140364CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBEIYNSubstantially EquivalentChison Medical Imaging Co., Ltd.accessdata.fda.gov
March 5, 2014K131900CONTEC ELECTROCARDIOGRAPHDPSSubstantially EquivalentContec Medical System Co., Ltd.accessdata.fda.gov
August 13, 2013K123473HOPER PTCA BALLOON CATHETERLOXSubstantially EquivalentLepu Medical Technology (Beijing) Co., Ltd.accessdata.fda.gov
August 1, 2013K131305CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBEIYNSubstantially EquivalentChison Medical Imaging Co., Ltd.accessdata.fda.gov
August 2, 2012K121867SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMSIYNSubstantially EquivalentChison Medical Imaging Co., Ltd.accessdata.fda.gov
June 14, 2012K120801CHISON DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially EquivalentChison Medical Imaging Co., Ltd.accessdata.fda.gov
May 1, 2012K113833VITAL SIGNS MONITORMWISubstantially EquivalentGuangdong Biolight Meditech Co., Ltd.accessdata.fda.gov
February 3, 2012K113359CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBEIYNSubstantially EquivalentChison Medical Imaging Co., Ltd.accessdata.fda.gov
November 18, 2011K102833DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETSMPBSubstantially EquivalentFoshan Nanhai Bai HE Medical Technology Co., Ltd.accessdata.fda.gov
July 1, 2010K101669THERMODILUTION CATHETERDQOSubstantially EquivalentBiosensors Intl. Pte. , Ltd.accessdata.fda.gov
May 17, 2010K100203HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300MDQASubstantially EquivalentBeijing Choice Electronic Technololgy Co., Ltd.accessdata.fda.gov
October 28, 2009K092245ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100DXQSubstantially EquivalentHonsun (Nantong) Co., Ltd.accessdata.fda.gov
July 31, 2007K070451ABLE CENTRAL VENOUS CATHETERFOZSubstantially EquivalentFoshan Nanhai Bai HE Medical Technology Co., Ltd.accessdata.fda.gov
February 5, 1999K983372BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BPDRSSubstantially EquivalentSunscope Intl., Inc.accessdata.fda.gov

Compare with other makers

Updated January 7, 2022. 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.