Repro-Med Systems, Inc.
Repro-Med Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 1985, most recent 2011, with 3 FDA device recalls on record.
Top product codes for Repro-Med Systems, Inc.
FDA recalls by Repro-Med Systems, Inc.
- Z-0051-2020 — 20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are intended for the delivery of medication to the subcutaneous tissue.
- Z-0318-2018 — HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS12609, RMS62612, RMS62606, RMS12406, RMS22412, RMS12412, RMS42606, RMS62609, RMS52612, RMS42612, RMS32609, RMS22609, RMS22606, RMS42609 & RMS32612.
- Z-0317-2018 — Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Repro-Med Systems, Inc.
- K102512 — RMS SUBCUTANEOUS NEEDLE SET
- K981506 — RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV)
- K933652 — FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBING
- K894299 — REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM
- K892529 — REPRO-MED NEONATE ASPIRATION SYSTEM
- K844401 — REPRO-MED SYSTEMS INFUSION DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.