Paragon Medical Device Changzhou Co L T D

FDA Filings

This page includes the latest FDA filings for Paragon Medical Device Changzhou Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3007539489
• FEI Number: 3007539489
• Name: Paragon Medical Device (Changzhou) Co., Ltd.
• Owner & Operator: PARAGON MEDICAL, INC.
• Contact Address: 8 Matchett Dr. --; Pierceton IN 46562 US
• US Agent:
  • Mike Gosmeyer
  • Paragon Medical, Inc.
  • 574 5942140 10381
  • mike.gosmeyer@nninc.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3A GDH Industrial Park No. 16 Chuangye Road; Changzhou Jiangsu, 213033 CN
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K182121 | OLO Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	RG SOLERA AWL-TIP TAP SHORT	2018-11-27
PMN K182121 | OLO Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	RG SOLERA AWL-TIP TAP LONG	2018-11-27
PMN K182121 | OLO Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	RG DRILL 3 x 30 SHORT	2018-11-27
PMN K182121 | OLO Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	RG DRILL 3 x 30 LONG	2018-11-27
PMN K182121 | OLO Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	RG BALLAST TAP LONG	2018-11-27
PMN K182121 | OLO Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	RG BALLAST DRILL 4.2 x 70 LONG	2018-11-27
PMN K182121 | OLO Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	RG AWL-TIP TAP LONG	2018-11-27
PMN K182121 | OLO Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	RG 9.5 BALLAST TAP LONG	2018-11-27
PMN K182121 | OLO Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	RG 8.5 BALLAST TAP LONG	2018-11-27
PMN K182121 | OLO Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	RG 11.5 BALLAST TAP LONG	2018-11-27
PMN K182121 | OLO Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	RG 10.5 BALLAST TAP LONG	2018-11-27
PMN K172699 | HSB Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	AGILE NAIL STERILIZATION BOX EXTRACTION EMPTY	2018-11-09
PMN K172699 | HSB Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	AGILE NAIL STERILIZATION BOX EMPTY	2018-11-09
PMN K172183 | OBT Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	STERILIZATION BOX EMPTY	2018-11-09
PMN K172183 | OBT Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	QUAD PLATE PLUS CADDY EMPTY	2018-11-09
PMN K172183 | OBT Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	EXTENDED PLUS LINE CADDY EMPTY	2018-11-09
PMN K172183 | OBT Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	EIGHT PLATE PLUS CADDY EMPTY	2018-11-09
PMN K170650 | OSN Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	TRAUMA TRAY, TL-HEX, EMPTY	2018-11-09
PMN K170650 | KTT Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	TRAUMA TRAY, TL-HEX, EMPTY	2018-11-09
PMN K161466 | HSB Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	EXTRACTION INSTRUMENT TRAY EMPTY	2018-11-09
PMN K161466 | HSB Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	CHIMAERA INSTRUMENT TRAY, EMPTY	2018-11-09
PMN K161466 | HSB Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	CHIMAERA INSTRUMENT TRAY EXTRA EMPTY	2018-11-09
PMN K941048 | LXT Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	TRUELOK TRAUMA CASE, US	2015-12-14
PMN K941048 | LXT Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	TRUELOK TRAUMA - INSTRUMENTS CASE, US	2015-12-14
PMN K141760 | KTT Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	GALAXY WRIST TRAY EMPTY	2015-12-14
PMN K141571 | HSB Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ANKLE HINDFOOT NAILING SYSTEM - INSERTION INSTRUMENTS CASE EMPTY	2015-12-14
PMN K141571 | HSB Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ANKLE HINDFOOT NAILING SYSTEM - EXTRACTION INSTRUMENTS CASE EMPTY	2015-12-14
PMN K141571 | HSB Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ANKLE HINDFOOT NAILING SYSTEM - DRILLS AND REAMERS CASE EMPTY	2015-12-14
LXH Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	Orthopedic Manual Surgical Instrument	2007-12-28
LXH Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	LITe Funnel	2007-12-28
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	WalterLorenz Surgical Assist Arm	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	Tray, Surgical, Instrument	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	PRIMARY DELIVERY SYS	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	NEXGEN FEM RESECT BASE ASSY	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	MIS TKA IM LID	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	LCCK STEM PROV CASE, STR/OFS	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	LCCK STEM PROV BASE, FLUTED	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	LCCK REAMER BASE W/ T-HANDLE	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	LCCK FEM CUTTING INST CASE	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	LCCK FEM AUG & BOX PROV TRAY	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	LCCK BLOCK AUGMENT PROV BASE	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	LCCK ART SURFACE PROV CASE	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	GENERIC STACKABLE LID ASSY	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ELEOS? INSTRUMENTATION TRAY, TRAY LID STANDARD	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ELEOS? INSTRUMENTATION TRAY, TRAY LID SMALL	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ELEOS? INSTRUMENTATION TRAY, TIBIAL RESURFACING TRIALS, TRAY 6	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ELEOS? INSTRUMENTATION TRAY, TIBIAL RESURFACING PREPARATION INSTRUMENTS, TRAY 7	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ELEOS? INSTRUMENTATION TRAY, SEGMENTAL STEM TRIALS, TRAY 3	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ELEOS? INSTRUMENTATION TRAY, RESURFACING STEM TRIALS, TRAY 5	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ELEOS? INSTRUMENTATION TRAY, REAMERS, TRAY 1	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ELEOS? INSTRUMENTATION TRAY, PROXIMAL TIBIA TRIALS, TRAY 11	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ELEOS? INSTRUMENTATION TRAY, PROXIMAL DISTAL FEMORAL SEGMENTAL TRIALS, TRAY 4	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ELEOS? INSTRUMENTATION TRAY, PIN CADDY, KIT TO TRAY 8	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ELEOS? INSTRUMENTATION TRAY, PATELLA INSTRUMENTS, TRAY 10	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ELEOS? INSTRUMENTATION TRAY, MALE-MALE MIDSECTION TRIALS, TRAY 12	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ELEOS? INSTRUMENTATION TRAY, GENERAL RESURFACING INSTRUMENTS, TRAY 8	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ELEOS? INSTRUMENTATION TRAY, FEMORAL RESURFACING INSTRUMENTS, TRAY 9	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ELEOS? INSTRUMENTATION TRAY, AUGMENT PREPARATION AND TRIALING INSTRUMENTS, TRAY 13	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	ELEOS? INSTRUMENTATION TRAY, ASSEMBLY/DISASSEMBLY INSTRUMENTS, TRAY 2	1994-07-27
FSM Paragon Medical Device (Changzhou) Co., Ltd. [PARAGON MEDICAL, INC.]	A.L.P.S. Clavicle Plating System	1994-07-27