Medical Device Manufacturer · US , Middletown , NY

Repro-Med Systems, Inc. - FDA 510(k) Cleared Devices

6 submissions · 5 cleared · Since 1985

Recent clearances: RMS SUBCUTANEOUS NEEDLE SET, RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV), FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING

View 6 510(k) Devices ↓

6

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Repro-Med Systems, Inc. General Hospital ✕

3 devices

1-3 of 3

Cleared May 20, 2011

RMS SUBCUTANEOUS NEEDLE SET

General Hospital · 261d

Cleared May 18, 1994

FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING

General Hospital · 294d

Cleared Mar 12, 1985

REPRO-MED SYSTEMS INFUSION DEVICE

General Hospital · 119d