Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007836437

FEI Number

3007836437

Entity Name

HOSMED INC.

City/State/Country

Doral, FL, US

Establishment Address

3403 NW 82nd Avenue, Suite 102E, Doral, FL 33122, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Hosmed Inc (Owner Number: 10037002)

Owner / Operator Contact Address

3403 NW 82nd Avenue, Suite 102E, Doral, FL 33122, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212134

PMA Number

N/A

All Registered Proprietary Names

Cruise PTCA Balloon Catheter Pisa Operation Table Fury 10 Operation Table Fury 5 Operation Table Root 1 Operation Table Vertuo Central Venous Catheter Kit Spider Manifold HOSMED HOSMED VANGUARD 5 STATIONARY ULTRASOUND SYSTEM HOSMED VANGUARD 10 STATIONARY ULTRASOUND SYSTEM HOSMED VANGUARD 1 STATIONARY ULTRASOUND SYSTEM HOSMED 3 POSITION MANUAL HOSPITAL BED NB3M Bipolar Pacing Catheter BSC 12 Patient Monitor BSC 15 Patient Monitor HOSMED PATHFINDER 1 CONSOLE ULTRASOUND SYSTEM HOSMED PATHFINDER 2 CONSOLE ULTRASOUND SYSTEM HOSMED PATHFINDER 4 CONSOLE ULTRASOUND SYSTEM HOSMED PATHFINDER 6 CONSOLE ULTRASOUND SYSTEM Geminis Hemodialysis Kit HOSMED ADVENTURE 10 PORTABLE LAPTOP ULTRASOUND SYSTEM HOSMED ADVENTURE 1 PORTABLE LAPTOP ULTRASOUND SYSTEM HOSMED ADVENTURE 5 PORTABLE LAPTOP ULTRASOUND SYSTEM HOSMED HOSMED HYDRAULIC TRANSPORT STRETCHER NS5H HOSMED MANUAL TRANSPORT STRETCHER NS2M HOSMED AMBULANCE STRETCHER NAS3 HOSMED SCOUT 6 PORTABLE ULTRASOUND SYSTEM HOSMED SCOUT 1 PORTABLE ULTRASOUND SYSTEM HOSMED SCOUT 9 PORTABLE ULTRASOUND SYSTEM HOSMED SCOUT 4 PORTABLE ULTRASOUND SYSTEM Thermodilution Catheter HOSMED HOSMED BEDSIDE CABINET NBC1 HOSMED BEDSIDE CABINET NBC2 HOSMED OVER THE BED TABLE NOB1 HOSMED OVER THE BED TABLE NOB2 HOSMED Dosglide PVC Infusion Gravity Set , 20 drps/ml, 250 cm, DEHP Free, Latex Free, Y Port Dosglide PVC Infusion Pump Set Burette150 ml, 150 cm ,Filter 1.2 micron, DEHP Free, Latex Free, Y Port Dosglide PVC Infusion Pump Set , 20 drps/ml, 150 cm, DEHP Free, Latex Free, Needless Port Dosglide PVC Lightproof Infusion Pump Set, 20 drops/ml, 150 cm, DEHP Free, Latex Free, Needless Port Dosglide PVC Infusion Pump Set Burette150 ml, 250 cm ,Filter 1.2 micron, DEHP Free, Latex Free, Needless Port Dosglide PVC Infusion Pump Set , 20 drps/ml, 250 cm, DEHP Free, Latex Free,Y Port Dosglide PVC Infusion Pump Set Burette150 ml, 150 cm ,Filter 1.2 micron, DEHP Free, Latex Free, Needless Port Dosglide PVC Infusion Gravity Set , 20 drps/ml, 150 cm, DEHP Free, Y Port Dosglide PVC Infusion Pump Set, 20 Drops/ml, 150 cm, Filter 1.2 Micron, DEHP Free, Latex Free, Y Port Dosglide PVC Infusion Gravity Set , 20 drps/ml, 250 cm, DEHP Free, Y Port Dosglide PVC Infusion Gravity Set , 20 drps/ml, 150 cm, DEHP Free, Latex Free, Needless Port Dosglide PVC Infusion Gravity Set , 20 drps/ml, 150 cm, DEHP Free, Latex Free, Y Port Dosglide PVC Lightproof Bag Dosglide PVC Lightproof Infusion Pump Set, 20 drops/ml, 250 cm, DEHP Free, Latex Free, Y Port Dosglide PVC Infusion Pump Set, 20 Drops/ml, 250 cm, Filter 1.2 Micron, DEHP Free, Latex Free, Needles Port Dosglide PVC Infusion Pump Set, 20 Drops/ml, 250 cm, Filter 1.2 Micron, DEHP Free, Latex Free, Y Port Dosglide PVC Lightproof Infusion Pump Set, 20 drops/ml, 150 cm, DEHP Free, Latex Free, Y Port Dosglide PVC Lightproof Infusion Pump Set, 20 drops/ml, 250 cm, DEHP Free, Latex Free, Needless Port Dosglide PVC Infusion Pump Set Burette150 ml, 250 cm ,Filter 1.2 micron, DEHP Free, Latex Free, Y Port Dosglide PVC Infusion Pump Set , 20 drps/ml, 150 cm, DEHP Free, Latex Free, Y Port Dosglide PVC Infusion Gravity Set , 20 drps/ml, 250 cm, DEHP Free, Latex Free, Needless Port Dosglide PVC Infusion Pump Set, 20 Drops/ml, 150 cm, Filter 1.2 Micron, DEHP Free, Latex Free, Needles Port Dosglide PVC Infusion Pump Set , 20 drps/ml, 250 cm, DEHP Free, Latex Free, Needless Port HOSMED Disposable Catheter Starkglide NC PTCA Balloon Dilatation Catheter HOSMED EMERGENCY CART NET1 HOSMED EMERGENCY CART NET2 HOSMED HOSMED HOSMED MULTIPARAMETER PATIENT MONITOR MM10.4i HOSMED MULTIPARAMETER PATIENT MONITOR MM15i HOSMED MULTIPARAMETER PATIENT MONITOR MM12.1i TM4.3i Transport Monitor HOSMED 5 POSITION ELECTRIC HOSPITAL BED NB5E HOSMED 3 POSITION ELECTRIC BED HOSMED ICU HOSPITAL ELECTRIC BED NB5I Starkglide CTO PTCA Balloon Dilatation Catheter Challenger 5200 Mobile X-Ray Equipment Pioneer 5000 Diagnostic X-Ray System Pioneer 2500 Diagnostic X-Ray System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2023-05-10
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2024-02-06
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-07-26
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2022-05-31
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-11-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-11-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-11-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-04-09
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-04-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-04-09
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2013-07-05
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2024-05-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2024-01-22
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-01-22
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-01-22
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-01-22
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2024-01-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-04-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-04-09
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-04-09
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2024-07-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-04-08
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-04-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-04-08
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-04-08
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2013-07-05
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-11-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-11-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-11-23
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2024-05-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-11-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-11-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-11-23
BRY	Cabinet, Table And Tray, Anesthesia	Anesthesiology	Class 1	868.6100	2013-07-05
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-11-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-11-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-11-23
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-05-30
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2014-09-07
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-05-31
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2024-05-21
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2013-07-05
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-11-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-11-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-11-23
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2020-04-15
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2020-03-31
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2020-03-31
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2020-03-31
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2020-03-31
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2020-03-31
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-03-31
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2020-03-31
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-03-31
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-03-31
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2020-03-31
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2020-03-31
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2020-03-31
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2020-03-31
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2020-03-31
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2020-03-31
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2020-03-31
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2020-03-31
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2020-03-31
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2020-03-31
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2020-03-31
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2020-03-31
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2020-03-31
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2013-07-05
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2024-05-21
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2022-05-30
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2022-05-30

Official Correspondent

Fernando Lopez Dona

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hosmed Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K915301	Advance Medical Designs, Inc.	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	1992-12-11
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12
K791040	Shimadzu Corp.	SECTOR SCANNER, SDU-100, COMPUTERIZED	1979-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151
Z-0036-2024	Getinge Usa Sales Inc	1	Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007836437. Last updated year: 2026. Please use registration number 3007836437 when referencing this establishment in official correspondence.