Mark Cooper

FDA Filings

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

FDA Registration(s)

• Registration Number: 3006272282
• FEI Number: 3006272282
• Name: Mark Cooper
• Owner & Operator: HG Medical GmbH
• Contact Address: HG Medical GmbH Gewerbegebiet 16; Raisting DE-BY Bayern 82399 DE
• Official Correspondent:
  • Michael Visino
  • 049-8807-214343-26
• US Agent:
  • Mark Cooper
  • Darco International, Inc.
  • 304 5224883
  • 304 5220037
  • mcooper@darcointernational.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 810 Memorial Blvd ; Huntington, WV 25701 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device

• Registration Number: 3012864176
• FEI Number: 3012864176
• Name: Mark Cooper
• Owner & Operator: Dongguan KIO Electronic Materials Co., Ltd
• Contact Address: The 3rd Industrial District,DiChong, GaoBu Town,; DongGuan, CN-44 Guangdong 523273 CN
• US Agent:
  • Mark Cooper
  • DARCO International, Inc.
  • 304 5224883
  • mcooper@darcointernational.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 810 Memorial Blvd ; Huntington, WV 25701 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K192163 | HWC Mark Cooper [HG Medical GmbH]	Dynamic Nail	2020-02-03
PMN K192163 | HSB Mark Cooper [HG Medical GmbH]	Dynamic Nail	2020-02-03
PMN K193452 | JDR Mark Cooper [HG Medical GmbH]	Dynaforce	2020-01-29
PMN K193452 | HWC Mark Cooper [HG Medical GmbH]	Dynaforce	2020-01-29
PMN K193452 | HRS Mark Cooper [HG Medical GmbH]	Dynaforce	2020-01-29
PMN K190586 | HWC Mark Cooper [HG Medical GmbH]	Mini Monster	2020-01-16
PMN K191782 | HWC Mark Cooper [HG Medical GmbH]	Static Nails	2019-11-04
PMN K191782 | HSB Mark Cooper [HG Medical GmbH]	Static Nails	2019-11-04
PMN K182307 | KTW Mark Cooper [HG Medical GmbH]	Phantom Nail	2019-09-27
PMN K182307 | HWC Mark Cooper [HG Medical GmbH]	Phantom Nail	2019-09-27
ITW Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	Body Armor Sport	2019-08-26
PMN K182898 | MBI Mark Cooper [HG Medical GmbH]	TenoTac Implants	2019-08-05
PMN K183363 | HWC Mark Cooper [HG Medical GmbH]	Snap-Off Screws	2019-06-26
PMN K160300 | HWC Mark Cooper [HG Medical GmbH]	Dynaforce Rizzo	2019-06-26
PMN K160300 | HRS Mark Cooper [HG Medical GmbH]	Dynaforce Rizzo	2019-06-26
PMN K190365 | HWC Mark Cooper [HG Medical GmbH]	Paragon P53-207**	2019-05-15
PMN K190365 | HTN Mark Cooper [HG Medical GmbH]	Paragon P53-207**	2019-05-15
PMN K190365 | HRS Mark Cooper [HG Medical GmbH]	Paragon P53-207**	2019-05-15
PMN K172886 | HWC Mark Cooper [HG Medical GmbH]	Paragon Baby Gorilla Platten	2019-05-15
PMN K172886 | HTN Mark Cooper [HG Medical GmbH]	Paragon Baby Gorilla Platten	2019-05-15
PMN K172886 | HRS Mark Cooper [HG Medical GmbH]	Paragon Baby Gorilla Platten	2019-05-15
PMN K141478 | HWC Mark Cooper [HG Medical GmbH]	Locking Distal Fibula System	2019-04-30
PMN K141478 | HRS Mark Cooper [HG Medical GmbH]	Locking Distal Fibula System	2019-04-30
PMN K173710 | HWC Mark Cooper [HG Medical GmbH]	Dyna Force System	2019-04-04
PMN K173710 | HRS Mark Cooper [HG Medical GmbH]	Dyna Force System	2019-04-04
PMN K172617 | HWC Mark Cooper [HG Medical GmbH]	Compression Screws	2019-04-04
PMN K180024 | HWC Mark Cooper [HG Medical GmbH]	Salvation Nail SMN	2019-03-13
PMN K163044 | HWC Mark Cooper [HG Medical GmbH]	Cortical Screw Full	2019-03-13
PMN K163044 | HRS Mark Cooper [HG Medical GmbH]	Cortical Screw Full	2019-03-13
PMN K163039 | HRS Mark Cooper [HG Medical GmbH]	3Di Plates	2019-03-13
PMN K150073 | HSB Mark Cooper [HG Medical GmbH]	Micronail	2019-03-13
PMN K142121 | HRS Mark Cooper [HG Medical GmbH]	CLC Frac Plate	2019-03-13
PMN K133713 | HWC Mark Cooper [HG Medical GmbH]	Snap Off Screws	2019-03-13
PMN K131093 | HRS Mark Cooper [HG Medical GmbH]	APS Plates	2019-03-13
PMN K120802 | HWC Mark Cooper [HG Medical GmbH]	Low Pro Cort Screw	2019-03-13
PMN K120802 | HRS Mark Cooper [HG Medical GmbH]	Low Pro Cort Screw	2019-03-13
PMN K111432 | HWC Mark Cooper [HG Medical GmbH]	Cleaning Stylet	2019-03-13
PMN K111432 | HRS Mark Cooper [HG Medical GmbH]	Cleaning Stylet	2019-03-13
PMN K110522 | KWP Mark Cooper [HG Medical GmbH]	Valor Screw	2019-03-13
PMN K051017 | KTT Mark Cooper [HG Medical GmbH]	FIxation Pin	2019-03-13
ITQ Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	KNEE IMOBILIZER	2019-02-06
IPY Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	DUAL ADJUSTABLE BACK SUPPORT	2019-02-06
HXX Mark Cooper [HG Medical GmbH]	Medline Screwdriver MPN3000X / MSN3000X	2019-01-31
PMN K181820 | HWC Mark Cooper [HG Medical GmbH]	Mini Plates and Screws	2018-11-02
PMN K181820 | HRS Mark Cooper [HG Medical GmbH]	Mini Plates and Screws	2018-11-02
ILI Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	CRADLE SLING	2018-06-07
ILH Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	WRIST BRACE	2018-06-07
ILH Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	BLACK FOAM WRIST BRACE	2018-06-07
PMN K172786 | HRS Mark Cooper [HG Medical GmbH]	MDS Broad and Narrow Plates	2018-05-18
PMN K163650 | HRS Mark Cooper [HG Medical GmbH]	WMT ANT Platten	2018-05-04
PMN K121425 | HRS Mark Cooper [HG Medical GmbH]	WMT ANT Platten	2018-05-04
PMN K162898 | HWC Mark Cooper [HG Medical GmbH]	MDS Olecranon	2018-05-02
PMN K162898 | HRS Mark Cooper [HG Medical GmbH]	MDS Olecranon	2018-05-02
PMN K141493 | HRS Mark Cooper [HG Medical GmbH]	MDS Proximal Humerus	2018-05-02
PMN K170889 | HWC Mark Cooper [HG Medical GmbH]	Wright-HV Screws	2018-04-26
PMN K173900 | PHX Mark Cooper [HG Medical GmbH]	Arthrex - Peripheral Schrauben	2018-04-24
PMN K153531 | HWC Mark Cooper [HG Medical GmbH]	Treace - Python Plates and Screws	2018-04-20
PMN K153531 | HRS Mark Cooper [HG Medical GmbH]	Treace - Python Plates and Screws	2018-04-20
PMN K153378 | HWC Mark Cooper [HG Medical GmbH]	Paragon - Monster Bite Screws	2018-03-23
PMN K151418 | HWC Mark Cooper [HG Medical GmbH]	Paragon - Monster Screws and Washers	2018-03-23
PMN K151418 | HTN Mark Cooper [HG Medical GmbH]	Paragon - Monster Screws and Washers	2018-03-23
NOC Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	WEDGE NIGHT SPLINT	2018-02-09
NOC Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	TOE ALIGNMENT SPLINT	2018-02-09
NOC Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	GREAT TOE SPLINT	2018-02-09
NOC Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	DORSAL NIGHT SPLINT	2018-02-09
NOC Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	BODY ARMOR WALKER	2018-02-09
NOC Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	BODY ARMOR DORSAL NIGHT SPLINT	2018-02-09
FZF Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	PNEUMATIC NIGHT SPLINT	2018-02-09
FZF Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	Air Traveler Walker	2018-02-09
FMP Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	Promotion Insole	2018-02-09
FMP Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	MULTI PHASE PAD	2018-02-09
IPG Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	Slimline Cast Boot	2017-09-12
IPG Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	Cast Shoe	2017-09-12
IPG Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	Body Armor Cast Shoe	2017-09-12
PMN K170547 | HRS Mark Cooper [HG Medical GmbH]	Arthrex - Mesh Plate	2017-09-08
PMN K170782 | HWC Mark Cooper [HG Medical GmbH]	Medline - SnapOff	2017-08-22
PMN K152306 | HWC Mark Cooper [HG Medical GmbH]	CrossRoads - 3,5 Non-Locking, 3,0 Locking, MotoBand-CP Plates	2017-08-02
PMN K152306 | HRS Mark Cooper [HG Medical GmbH]	CrossRoads - 3,5 Non-Locking, 3,0 Locking, MotoBand-CP Plates	2017-08-02
PMN K170693 | KTW Mark Cooper [HG Medical GmbH]	Lapidus Nail System - Paragon	2017-07-06
PMN K170693 | HWC Mark Cooper [HG Medical GmbH]	Lapidus Nail System - Paragon	2017-07-06
GXB Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	SINGLE USE MONOFILAMENT	2017-04-21
GXB Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	MONOFILAMENT FOOT SCREEN TEST	2017-04-21
GXB Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	MFT	2017-04-21
PMN K143717 | HWC Mark Cooper [HG Medical GmbH]	Treace - Python/Curved/Screws	2017-02-27
PMN K143717 | HRS Mark Cooper [HG Medical GmbH]	Treace - Python/Curved/Screws	2017-02-27
PMN K150456 | HRS Mark Cooper [HG Medical GmbH]	Lapidus Plantar Plate Short - Arthrex	2017-01-25
PMN K162829 | HWC Mark Cooper [HG Medical GmbH]	Medline MPPA / Cancellous / Hock	2016-12-12
PMN K162829 | HRS Mark Cooper [HG Medical GmbH]	Medline MPPA / Cancellous / Hock	2016-12-12
PMN K052614 | HRS Mark Cooper [HG Medical GmbH]	Distal Fibular Plate - Arthrex	2016-11-15
PMN K151732 | HRS Mark Cooper [HG Medical GmbH]	Posteriolateral Plates - Arthrex	2016-11-11
KNP Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	SQUARE TOE MEDICAL SHOE	2016-10-05
KNP Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	SQUARE TOE APB	2016-10-05
KNP Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	ORTHOWEDGE	2016-10-05
KNP Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	DUO SHOE	2016-10-05
KNP Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	CLASSIC POST OP	2016-10-05
KNP Mark Cooper [Dongguan KIO Electronic Materials Co., Ltd]	ALL PURPOSE BOOT	2016-10-05
PMN K913930 | HRS Mark Cooper [HG Medical GmbH]	Rayhack System Wright	2016-06-22
PMN K152072 | HWC Mark Cooper [HG Medical GmbH]	CrossRoads Headed 5.0 / 6.5	2015-10-09
PMN K143039 | HWC Mark Cooper [HG Medical GmbH]	CrossRoads Headed 3.0 / 4.0	2015-10-09
PMN K132217 | HWC Mark Cooper [HG Medical GmbH]	Arthrex Headless Comp. Screw	2015-10-09
PMN K151235 | HWC Mark Cooper [HG Medical GmbH]	Medline MTP Plate System	2015-08-07
PMN K151235 | HRS Mark Cooper [HG Medical GmbH]	Medline MTP Plate System	2015-08-07
PMN K141784 | KTT Mark Cooper [HG Medical GmbH]	GEN II Screws / Plates; 3.5 Cannulated Screws	2015-05-20
PMN K141784 | HWC Mark Cooper [HG Medical GmbH]	GEN II Screws / Plates; 3.5 Cannulated Screws	2015-05-20
PMN K141784 | HRS Mark Cooper [HG Medical GmbH]	GEN II Screws / Plates; 3.5 Cannulated Screws	2015-05-20
PMN K121575 | HSB Mark Cooper [HG Medical GmbH]	Oxford AFN 5.0; End Caps	2015-05-20
PMN K111678 | JDR Mark Cooper [HG Medical GmbH]	EFS LAG Screw; Weil Screw; Nail Plate Screw; GEN I Plates / Screws	2015-05-20
PMN K111678 | HWC Mark Cooper [HG Medical GmbH]	EFS LAG Screw; Weil Screw; Nail Plate Screw; GEN I Plates / Screws	2015-05-20
PMN K111678 | HRS Mark Cooper [HG Medical GmbH]	EFS LAG Screw; Weil Screw; Nail Plate Screw; GEN I Plates / Screws	2015-05-20
PMN K111253 | HWC Mark Cooper [HG Medical GmbH]	Plantar Lapidus Plate - Arthrex	2015-05-20
PMN K111253 | HRS Mark Cooper [HG Medical GmbH]	Plantar Lapidus Plate - Arthrex	2015-05-20
PMN K094037 | HRS Mark Cooper [HG Medical GmbH]	TC Plating System (OrthoPro)	2015-02-02
PMN K140749 | HSN Mark Cooper [HG Medical GmbH]	Pin 3,2 Infinity	2015-01-28
PMN K123954 | HSN Mark Cooper [HG Medical GmbH]	Temp Fix Pin Talar	2015-01-28
PMN K040938 | HRS Mark Cooper [HG Medical GmbH]	MicroNail	2015-01-28
PMN K140741 | HWC Mark Cooper [HG Medical GmbH]	Beam / Bolt Screws	2014-08-08
PMN K140397 | HWC Mark Cooper [HG Medical GmbH]	ParaLock Plating System and Plate Screws	2014-05-05
PMN K140397 | HTN Mark Cooper [HG Medical GmbH]	ParaLock Plating System and Plate Screws	2014-05-05
PMN K140397 | HRS Mark Cooper [HG Medical GmbH]	ParaLock Plating System and Plate Screws	2014-05-05
PMN K131380 | HWC Mark Cooper [HG Medical GmbH]	TWF Plating System Acumed	2014-05-05
PMN K131380 | HRS Mark Cooper [HG Medical GmbH]	TWF Plating System Acumed	2014-05-05
PMN K124027 | HWC Mark Cooper [HG Medical GmbH]	Headed_Headless 3.5/4.0; MonsterBites (P28)	2014-03-21
PMN K124027 | HTN Mark Cooper [HG Medical GmbH]	Headed_Headless 3.5/4.0; MonsterBites (P28)	2014-03-21
PMN K100359 | HWC Mark Cooper [HG Medical GmbH]	Darco Headed Screws	2013-11-04
PMN K130319 | HWC Mark Cooper [HG Medical GmbH]	Smooth or threaded metallic bone fixation fastener, Washer	2013-06-11
PMN K121651 | HRS Mark Cooper [HG Medical GmbH]	ORTHOLOC 3DI Midfoot/Flatfoot System	2012-11-02
PMN K120359 | HRS Mark Cooper [HG Medical GmbH]	ORTHOLOC 3DI HALLUX SYSTEM	2012-11-02
PMN K102429 | HWC Mark Cooper [HG Medical GmbH]	ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW	2011-10-14
PMN K102429 | HRS Mark Cooper [HG Medical GmbH]	ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW	2011-10-14
MDM Mark Cooper [HG Medical GmbH]	Locon - T Quick	2010-03-02
MDM Mark Cooper [HG Medical GmbH]	HTO Freecut Technique Keyhole Guide	2010-03-02
LXH Mark Cooper [HG Medical GmbH]	Screw Gripper	2010-03-02
LXH Mark Cooper [HG Medical GmbH]	Bone Fragment Pick	2010-03-02
LRP Mark Cooper [HG Medical GmbH]	Plate Tray, Instrument Tray, Screw Tray	2010-03-02
HWW Mark Cooper [HG Medical GmbH]	Countersink	2010-03-02
HWR Mark Cooper [HG Medical GmbH]	Driver	2010-03-02
HWR Mark Cooper [HG Medical GmbH]	Drive Star	2010-03-02
HWE Mark Cooper [HG Medical GmbH]	K-Wire	2010-03-02
HWE Mark Cooper [HG Medical GmbH]	Cleaning Stylet	2010-03-02
HWE Mark Cooper [HG Medical GmbH]	AO Quick Connect	2010-03-02
HTJ Mark Cooper [HG Medical GmbH]	Depth Guide	2010-03-02
HTJ Mark Cooper [HG Medical GmbH]	Depth Gage	2010-03-02
HTD Mark Cooper [HG Medical GmbH]	Forceps	2010-03-02
HTD Mark Cooper [HG Medical GmbH]	Bone Reduction Clamp	2010-03-02
FZX Mark Cooper [HG Medical GmbH]	Drill Guide	2010-03-02
GFG Mark Cooper [HG Medical GmbH]	Drill	2010-03-01
GFG Mark Cooper [HG Medical GmbH]	Drill Bit	2010-03-01
PMN K091243 | HWC Mark Cooper [HG Medical GmbH]	Ortholoc Ankle Plating System	2009-10-14
PMN K091243 | HRS Mark Cooper [HG Medical GmbH]	Ortholoc Ankle Plating System	2009-10-14
PMN K090857 | HSB Mark Cooper [HG Medical GmbH]	Valor Ankle Fusion Nail System	2009-10-14
PMN K090692 | HWC Mark Cooper [HG Medical GmbH]	Ortholoc 2.0/2.4 Plate System	2009-10-14
PMN K090692 | HRS Mark Cooper [HG Medical GmbH]	Ortholoc 2.0/2.4 Plate System	2009-10-14
PMN K082320 | HWC Mark Cooper [HG Medical GmbH]	Washer	2009-10-14
PMN K082320 | HWC Mark Cooper [HG Medical GmbH]	Smooth or threaded metallic bone fixation fastener	2009-10-14
PMN K062103 | HWC Mark Cooper [HG Medical GmbH]	DARCO Force Compression Screw	2007-11-01
PMN K061808 | HRS Mark Cooper [HG Medical GmbH]	DARCO Locking Bone Plate System	2007-11-01

Similar & Related FDA Registered Companies

• DARCO INTERNATIONAL, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020050163145	Yantian,China (Mainland) -> Oakland, California	COIN	1 PCS
2020021746419	Bremerhaven,Federal Republic of Germany -> Baltimore, Maryland	CARADO T337 WOHNMOBIL VIN	1 UNT
2019013116582	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	LOUDSPEAKER	5 CTN