New York FDA 510(k) clearances, last 90 days
US companies with an FDA 510(k) clearance and a New York address from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.
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Last 90 days
14 clearances in the last 90 days. The same 90 days a year earlier: 9.
For contract manufacturers and test labs
New York had 14 US 510(k) clearances in the last 90 days and 60 in the last 12 months. The product code with the most clearances in this window is DPW (Flowmeter, Blood, Cardiovascular). Contract manufacturers and test labs that sell to device companies in New York can read the company, the device and the date below, then open the FDA record. Contacts for these companies come with a free month.
Top product codes
| Product code | Device type | Clearances |
|---|---|---|
DPW | Flowmeter, Blood, Cardiovascular | 1 |
DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 |
FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 |
HAW | Neurological Stereotaxic Instrument | 1 |
IYE | Accelerator, Linear, Medical | 1 |
| Decision date | Company | Device | FDA record |
|---|---|---|---|
| Oct 30, 2026 | AngioDynamics, Inc. | AngioVac F1885 | K263076 |
| Oct 27, 2026 | Transonic Systems, Inc. | FlowXL System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors | K261714 |
| Oct 26, 2026 | Medivis, Inc. | NeuroAlign | K261997 |
| Oct 16, 2026 | Bausch + Lomb, Inc. | Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens | K262941 |
| Oct 7, 2026 | Ceiba Healthcare US, Inc. | eClinics | K260075 |
| Sep 11, 2026 | Xtreem Pulse, LLC | PureLift Pro Max | K262861 |
| Sep 11, 2026 | Zbeats, Inc. | ZBPro Diagnostic (Version 2.0) | K261580 |
| Sep 11, 2026 | Microstructure Imaging, Inc. | MICSI-PET | K261305 |
| Sep 4, 2026 | Peerbridge Health, Inc. | Peerbridge COR MDx (Cor MDx) | K253529 |
| Aug 31, 2026 | Radformation, Inc. | EZFluence (RADEZ V2) | K261718 |
| Aug 27, 2026 | Ascensia Diabetes Care | CONTOUR PLUS BLUE Blood Glucose Monitoring System; CONTOUR NEXT GEN Blood Glucose Monitoring System; CONTOUR NEXT ONE Blood Glucose Monitoring System | K260545 |
| Aug 14, 2026 | Radformation, Inc. | AutoContour (RADAC V6) | K262452 |
| Aug 10, 2026 | Spectrum Vascular | Unimpregnated Central Venous Catheter | K260165 |
| Aug 10, 2026 | Siemens Healthcare Diagnostics, Inc. | Atellica IM CA 19-9 II | K253528 |
- Oct 30, 2026AngioDynamics, Inc.
AngioVac F1885
- Oct 27, 2026Transonic Systems, Inc.
FlowXL System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors
- Oct 26, 2026Medivis, Inc.
NeuroAlign
- Oct 16, 2026Bausch + Lomb, Inc.
Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens
- Oct 7, 2026Ceiba Healthcare US, Inc.
eClinics
- Sep 11, 2026Xtreem Pulse, LLC
PureLift Pro Max
- Sep 11, 2026Zbeats, Inc.
ZBPro Diagnostic (Version 2.0)
- Sep 11, 2026Microstructure Imaging, Inc.
MICSI-PET
- Sep 4, 2026Peerbridge Health, Inc.
Peerbridge COR MDx (Cor MDx)
- Aug 31, 2026Radformation, Inc.
EZFluence (RADEZ V2)
- Aug 27, 2026Ascensia Diabetes Care
CONTOUR PLUS BLUE Blood Glucose Monitoring System; CONTOUR NEXT GEN Blood Glucose Monitoring System; CONTOUR NEXT ONE Blood Glucose Monitoring System
- Aug 14, 2026Radformation, Inc.
AutoContour (RADAC V6)
- Aug 10, 2026Spectrum Vascular
Unimpregnated Central Venous Catheter
- Aug 10, 2026Siemens Healthcare Diagnostics, Inc.
Atellica IM CA 19-9 II
Source: FDA public records. The K number is in Whimbrel's corpus, and the company, device, state, product code and review panel are the openFDA 510(k) fields for that K number. FDA data through October 30, 2026. Each K number links to the FDA record. openFDA data are not validated by the FDA for medical decisions. Check the FDA record before you rely on a row. openFDA 510(k) API. FDA 510(k) database.
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