Data / Medical devices / Singapore / Merit Medical Singapore Pte. Ltd.
Merit Medical Singapore Pte. Ltd.: FDA-registered device maker in SINGAPORE Central Singapore, Singapore, 11 510(k) clearances
Merit Medical Singapore Pte. Ltd. is registered with the FDA (registration 8020616) in SINGAPORE Central Singapore, Singapore. It lists 12 device types. The FDA files 11 510(k) clearances under its listings, the newest dated January 2, 1998. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8020616
- FEI number
- 3002806476
- Address
- 198 Yishun Ave. 7, SINGAPORE Central Singapore, Singapore, 768926
- Owner or operator
- Merit Medical Systems, Inc. (1721504)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 17, 2017
- Registered through
- 2026
- Brand names listed
- Bath Probe, Cardiac Output Kit, Catheter Connection Cable, Catheter Connection Cables and Cardia Computer, Connecta PE Lines, Critiflo, Critiflo Dome, Critikit Plus In-Line Room/ Ice Injectate and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Actuator, Syringe, Injector Type | DQF | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Continuous Flush | KRA | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Manufacturer | accessdata.fda.gov |
| Computer, Blood-Pressure | DSK | 2 | Manufacturer | accessdata.fda.gov |
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | 2 | Specification developer | accessdata.fda.gov |
| Intravenous Extension Tubing Set | OJA | 2 | Manufacturer | accessdata.fda.gov |
| Probe, Thermodilution | KRB | 2 | Manufacturer | accessdata.fda.gov |
| Stopcock, I.V. Set | FMG | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Blood-Pressure, Extravascular | DRS | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Manufacturer | accessdata.fda.gov |
| Tubing, Fluid Delivery | FPK | 2 | Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 2, 1998 | K974374 | SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV | JKA | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
| August 1, 1994 | K935782 | DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES | DXN | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
| March 25, 1994 | K936182 | CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT | KRB | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
| January 25, 1989 | K885235 | SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. | DSK | Substantially Equivalent | Spectramed, Inc. | accessdata.fda.gov |
| March 22, 1988 | K880740 | MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE | DQF | Substantially Equivalent | Spectramed, Inc. | accessdata.fda.gov |
| April 1, 1987 | K870261 | VIGGO EXACTA PRESSURE MONITORING SYSTEM | FMG | Substantially Equivalent | Ohmeda Medical | accessdata.fda.gov |
| August 18, 1986 | K861092 | MODEL SP1465 CARDIAC OUTPUT COMPUTER | DXG | Substantially Equivalent | Gould, Inc. | accessdata.fda.gov |
| February 26, 1986 | K855145 | MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR | DRS | Substantially Equivalent | Gould, Inc. | accessdata.fda.gov |
| March 16, 1983 | K830523 | CATHETER CONNECTION W/INTEGRAL INJECTATE | DQO | Substantially Equivalent | Gould, Inc. | accessdata.fda.gov |
| May 25, 1982 | K821450 | PRESSURE TUBING-ADULT & PEDIATRIC | DRS | Substantially Equivalent | Gould, Inc. | accessdata.fda.gov |
| October 2, 1979 | K791844 | CRITIFLO & CRITIFLO DOME | KRA | Substantially Equivalent | Gould, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Probe, Thermodilution
- All makers of Computer, Blood-Pressure
- All makers of Transducer, Blood-Pressure, Extravascular
- All makers of Intravenous Extension Tubing Set
- All makers of Catheter, Continuous Flush
- All makers of Stopcock, I.V. Set
Updated January 2, 1998. 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.