Data / Medical devices / United States / Novamed-Usa
Novamed-Usa: FDA-registered device maker in Elmsford, NY, United States, 6 510(k) clearances
Novamed-Usa is registered with the FDA (registration 2432320) in Elmsford, NY, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 9, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2432320
- FEI number
- 1000521377
- Address
- 4 Westchester PLZ Ste 137, Elmsford, NY, United States, 10523
- Owner or operator
- NovaMedUSA, Inc (10030147)
- Roles
- Complaint file establishment
- First device listed
- August 19, 2009
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory Equipment, Cardiopulmonary Bypass | KRI | 1 | Complaint file establishment | accessdata.fda.gov |
| Catheter, Retention Type, Balloon | EZL | 2 | Complaint file establishment | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Complaint file establishment | accessdata.fda.gov |
| Stethoscope, Esophageal, With Electrical Conductors | BZT | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Thermal Regulating | DWJ | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| February 9, 2007 | K063477 | NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET | CCW | Substantially Equivalent | Novamed, LLC | accessdata.fda.gov |
| December 8, 2006 | K061902 | COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 | DWJ | Substantially Equivalent | Inditherm Medical | accessdata.fda.gov |
| September 5, 2006 | K062020 | LIFESOUND ESOPHAGEAL STETHOSCOPE | BZT | Substantially Equivalent | Novamed, LLC | accessdata.fda.gov |
| April 27, 2006 | K051419 | INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1 | DWJ | Substantially Equivalent | Inditherm Medical | accessdata.fda.gov |
| September 23, 2002 | K022287 | 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS | EZL | Substantially Equivalent | 3t Medical Systems, LLC | accessdata.fda.gov |
| May 3, 2002 | K020365 | 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE | KRI | Substantially Equivalent | 3t Medical Systems, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of System, Thermal Regulating
- All makers of Stethoscope, Esophageal, With Electrical Conductors
- All makers of Catheter, Retention Type, Balloon
- All makers of Accessory Equipment, Cardiopulmonary Bypass
- All makers of Laryngoscope, Rigid
Updated February 9, 2007. 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.