Simpex Medical Inc

FDA Filings

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

Simpex Medical Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Richard Gorski

FDA Registration(s)

• Registration Number: 3025266
• FEI Number: 1000126034
• Name: SIMPEX MEDICAL, INC.
• Owner & Operator: SIMPEX MEDICAL, INC.
• Contact Address: 2780 Disney Place --; Fort Mill SC 29707 US
• Official Correspondent:
  • RICHARD - GORSKI
  • x-800-8519753-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1974 Carolina Place Drive Suite 216-A; Fort Mill, SC 29708 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
GUDID B068DB25051 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-250-5	2019-10-28
GUDID B068DB250101 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-250-10	2019-10-28
GUDID B068DB23651 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-236-5	2019-10-28
GUDID B068DB235101 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-236-10	2019-10-28
GUDID B068DB18751 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-187-5	2019-10-28
GUDID B068DB187101 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-187-10	2019-10-28
GUDID B068DB17751 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-177-5	2019-10-28
GUDID B068DB177101 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-177-10	2019-10-28
GUDID B068DB17151 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-171-5	2019-10-28
GUDID B068DB171101 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-171-10	2019-10-28
GUDID B068DB15651 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-156-5	2019-10-28
GUDID B068DB156101 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-156-10	2019-10-28
GUDID B068DB14051 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-140-5	2019-10-28
GUDID B068DB12581 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-125-8	2019-10-28
GUDID B068DB12551 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-125-5	2019-10-28
GUDID B068DB12541 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-125-4	2019-10-28
GUDID B068DB1253251 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-125-325	2019-10-28
GUDID B068DB125101 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-125-10	2019-10-28
GUDID B068DB10951 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-109-5	2019-10-28
GUDID B068DB109121 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-109-12	2019-10-28
GUDID B068DB09851 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-098-5	2019-10-28
GUDID B068DB09351 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-093-5	2019-10-28
GUDID B068DB07851 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-078-5	2019-10-28
GUDID B068DB07051 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-070-5	2019-10-28
GUDID B068DB06251 SIMPEX MEDICAL, INC.	Simpex Drill Bit DB-062-5	2019-10-28
GUDID B068KD06212S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-062-12S	2018-07-06
GUDID B068KD062121 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-062-12	2018-07-06
GUDID B068KD0549S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-054-9S	2018-07-06
GUDID B068KD05491 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-054-9	2018-07-06
GUDID B068KD0546S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-054-6S	2018-07-06
GUDID B068KD05461 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-054-6	2018-07-06
GUDID B068KD0545S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-054-5S	2018-07-06
GUDID B068KD05451 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-054-5	2018-07-06
GUDID B068KD0544S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-054-4S	2018-07-06
GUDID B068KD05441 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-054-4	2018-07-06
GUDID B068KD05412S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-054-12S	2018-07-06
GUDID B068KD054121 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-054-12	2018-07-06
GUDID B068KD0459S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-045-9S	2018-07-06
GUDID B068KD04591 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-045-9	2018-07-06
GUDID B068KD0456S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-045-6S	2018-07-06
GUDID B068KD04561 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-045-6	2018-07-06
GUDID B068KD0455S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-045-5S	2018-07-06
GUDID B068KD04551 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-045-5	2018-07-06
GUDID B068KD0454S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-045-4S	2018-07-06
GUDID B068KD04541 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-045-4	2018-07-06
GUDID B068KD04512S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-045-12S	2018-07-06
GUDID B068KD045121 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-045-12	2018-07-06
GUDID B068KD0359S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-035-9S	2018-07-06
GUDID B068KD03591 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-035-9	2018-07-06
GUDID B068KD0356S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-035-6S	2018-07-06
GUDID B068KD03561 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-035-6	2018-07-06
GUDID B068KD0355S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-035-5S	2018-07-06
GUDID B068KD03551 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-035-5	2018-07-06
GUDID B068KD0354S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-035-4S	2018-07-06
GUDID B068KD03541 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-035-4	2018-07-06
GUDID B068KD03512S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-035-12S	2018-07-06
GUDID B068KD035121 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-035-12	2018-07-06
GUDID B068KD0289S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-028-9S	2018-07-06
GUDID B068KD02891 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-028-9	2018-07-06
GUDID B068KD0286S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-028-6S	2018-07-06
GUDID B068KD02861 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-028-6	2018-07-06
GUDID B068KD0285S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-028-5S	2018-07-06
GUDID B068KD02851 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-028-5	2018-07-06
GUDID B068KD0284S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-028-4S	2018-07-06
GUDID B068KD02841 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-028-4	2018-07-06
GUDID B068KD02812S1 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-028-12S	2018-07-06
GUDID B068KD028121 SIMPEX MEDICAL, INC.	Simpex Kirschner Wire KD-028-12	2018-07-06
GUDID B068D187S1 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-187-S	2018-07-06
GUDID B068D18712S1 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-187-12S	2018-07-06
GUDID B068D187121 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-187-12	2018-07-06
GUDID B068D1871 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-187	2018-07-06
GUDID B068D177S1 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-177-S	2018-07-06
GUDID B068D17712S1 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-177-12S	2018-07-06
GUDID B068D177121 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-177-12	2018-07-06
GUDID B068D1771 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-177	2018-07-06
GUDID B068D156S1 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-156-S	2018-07-06
GUDID B068D15612S1 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-156-12S	2018-07-06
GUDID B068D156121 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-156-12	2018-07-06
GUDID B068D1561 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-156	2018-07-06
GUDID B068D140S1 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-140-S	2018-07-06
GUDID B068D14012S1 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-140-12S	2018-07-06
GUDID B068D140121 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-140-12	2018-07-06
GUDID B068D1401 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-140	2018-07-06
GUDID B068D125S1 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-125-S	2018-07-06
GUDID B068D12512S1 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-125-12S	2018-07-06
GUDID B068D125121 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-125-12	2018-07-06
GUDID B068D1251 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-125	2018-07-06
GUDID B068D109S1 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-109-S	2018-07-06
GUDID B068D10912S1 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-109-12S	2018-07-06
GUDID B068D109121 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-109-12	2018-07-06
GUDID B068D1091 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-109	2018-07-06
GUDID B068D093S1 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-093-S	2018-07-06
GUDID B068D09312S1 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-093-12S	2018-07-06
GUDID B068D093121 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-093-12	2018-07-06
GUDID B068D0931 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-093	2018-07-06
GUDID B068D078S1 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-078-S	2018-07-06
GUDID B068D07812S1 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-078-12S	2018-07-06
GUDID B068D078121 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-078-12	2018-07-06
GUDID B068D0781 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin D-078	2018-07-06
GUDID B068B125121 SIMPEX MEDICAL, INC.	Simpex Steinmann Pin B-125-12	2018-07-06
HTW SIMPEX MEDICAL, INC.	Drill Bit	2011-12-16
HTW SIMPEX MEDICAL, INC.	Drill Bit Round Shank	2011-12-16
HYA SIMPEX MEDICAL, INC.	Wire Twisting Forceps	2010-12-13
HYA SIMPEX MEDICAL, INC.	Wire Pulling Forceps	2010-12-13
HXZ SIMPEX MEDICAL, INC.	Side Kirschner Wire Cutter	2010-12-13
HXZ SIMPEX MEDICAL, INC.	Pin Cutter (Medium)	2010-12-13
HXZ SIMPEX MEDICAL, INC.	Pin Cutter (Large)	2010-12-13
HXZ SIMPEX MEDICAL, INC.	K-Wire Side Cutter	2010-12-13
HXZ SIMPEX MEDICAL, INC.	Front and Side Wire Cutter	2010-12-13
HXZ SIMPEX MEDICAL, INC.	Front and Side Flush Wire Cutter	2010-12-13
HXZ SIMPEX MEDICAL, INC.	Double Action Wire Cutter	2010-12-13
HXZ SIMPEX MEDICAL, INC.	Double Action Pin and Wire Cutter	2010-12-13
HXZ SIMPEX MEDICAL, INC.	Diamond Pin and Wire Cutter	2010-12-13
HXZ SIMPEX MEDICAL, INC.	Delicate Wire Cutter	2010-12-13
HXZ SIMPEX MEDICAL, INC.	Cannulated Cutter for Orthopedic Pins and Wires	2010-12-13
HXS SIMPEX MEDICAL, INC.	Pin Puller	2010-12-13
HXS SIMPEX MEDICAL, INC.	Needle Nose Pliers	2010-12-13
HXS SIMPEX MEDICAL, INC.	Needle Nose Locking Pliers - Medium	2010-12-13
HXS SIMPEX MEDICAL, INC.	Needle Nose Locking Pliers - Large	2010-12-13
HXS SIMPEX MEDICAL, INC.	Long Jaw Needle Nose Pliers	2010-12-13
HXS SIMPEX MEDICAL, INC.	Locking Pliers	2010-12-13
HXS SIMPEX MEDICAL, INC.	Flat Nose Pliers	2010-12-13
HXS SIMPEX MEDICAL, INC.	Flat Nose Pliers and Cutter	2010-12-13
HXS SIMPEX MEDICAL, INC.	Flat Nose K-Wire Pliers	2010-12-13
HXS SIMPEX MEDICAL, INC.	Double Action Wire Extraction Pliers	2010-12-13
PMN K911505 | HTY SIMPEX MEDICAL, INC.	Kirschner Wire	2008-01-03
PMN K911505 | HTY SIMPEX MEDICAL, INC.	K-Wire	2008-01-03
PMN K911452 | HTY SIMPEX MEDICAL, INC.	Steinmann Pin	2008-01-03