Koru Medical Systems

FDA Filings

This page includes the latest FDA filings for Koru Medical Systems. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1318360
• FEI Number: 1318360
• Name: REPRO-MED SYSTEMS, INC. dba KORU Medical Systems
• Owner & Operator: KORU Medical Systems
• Contact Address: 24 CARPENTER RD. ; Chester NY 10918 US
• Official Correspondent:
  • Cynthia I Lacatena
  • x-845-6105579-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 24 Carpenter Rd ; CHESTER, NY 10918 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K180843 | FPA REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	HlgH-Flo Super26 Subcutaneous Needle Sets	2019-04-08
PMN K162613 | PKP REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	Intagrated Catch-up Freedom Syringe Driver Infusion System	2017-09-12
PMN K162613 | FRN REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	Intagrated Catch-up Freedom Syringe Driver Infusion System	2017-09-12
PMN K162613 | FPA REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	Intagrated Catch-up Freedom Syringe Driver Infusion System	2017-09-12
PMN K033099 | FPA REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	RMS Soft Catheter	2015-12-18
PMN K122404 | FPA REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	RMS Subcutaneous Safety Needle Set	2014-03-10
PMN K122404 | FPA REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	RMS Subcutaneous Needle Set	2014-03-10
PMN K122404 | FPA REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	RMS HIgH-Flo Subcutaneous Safety Needle Sets	2014-03-10
PMN K122404 | FPA REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	HIgH-Flo Subcutaneous Safety Needle Sets	2014-03-10
PMN K102512 | FPA REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	RMS Subcutaneous Safety Needle Set	2011-12-14
PMN K102512 | FPA REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	RMS Subcutaneous Needle Set	2011-12-14
PMN K102512 | FPA REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	HIgH-Flo Subcutaneous Safety Needle Sets	2011-12-14
PMN K894299 | BSY REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	RES-Q-VAC	2010-12-06
PMN K894299 | BSY REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	Emergency Airway Vacuum System	2010-12-06
PMN K892529 | BSY REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	RES-Q-VAC; Neonate Aspiration System	2010-12-06
PMN K933652 | FRN REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	Freedom Edge	2007-12-20
PMN K933652 | FRN REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	Freedom 60 Syringe Infusion System	2007-12-20
PMN K933652 | FRN REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	FREEDOM60 Syringe Infusion System	2007-12-20
PMN K933652 | FRN REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	FREEDOM60 Precision Flow Rate Tubing	2007-12-20
PMN K853216 | HHK REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	Masterson Endometrial Biopsy Kit	2007-12-20
HIM REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	Gyneco Thermal Cautery Unit	2007-12-20
BSY REPRO-MED SYSTEMS, INC. dba KORU Medical Systems [KORU Medical Systems]	RES-Q-VAC AIRWAY SUCTION SYSTEM	2001-07-12

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020080669992	Taipei,China (Taiwan) -> Los Angeles, California	PEMALE CAP MALE CAP	70 CTN
2020080419066	Taipei,China (Taiwan) -> Los Angeles, California	PLASTIC WARES	273 CTN
2020072838094	Taipei,China (Taiwan) -> Los Angeles, California	PLASTIC WARES	273 CTN
2020072363363	Taipei,China (Taiwan) -> Los Angeles, California	PLASTIC WARES	273 CTN
2020071838460	Taipei,China (Taiwan) -> Los Angeles, California	MALE LUER LOCK FEMALE CAP MALE CAP SLIDE CLAMP	135 CTN
2020041849757	Taipei,China (Taiwan) -> Los Angeles, California	MALE LUER LOCK FEMALE CAP MALE CAP	48 CTN
202004016807	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	HOUSING BOTTON REV HOUSING TOP REV	70 CTN
2020032830295	Taipei,China (Taiwan) -> Los Angeles, California	MALE LUER LOCK FEMALE CAP MALE CAP SLIDE CLAMP	51 CTN