Randalle Mccoy

FDA Filings

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

FDA Registration(s)
Registration Number9680168
FEI Number1000295034
NameRANDALLE.MCCOY
Owner & OperatorUNITED POLY ENGINEERING PVT. LTD.
Contact AddressD-13/3 OKHLA INDUSTRIAL AREA PHASE II
NEW DELHI IN-DL Delhi 110020 IN
Official Correspondent
  • ASHISH - GROVER
  • 91-11-46438888-x
US Agent
Importing Logistics Registration
ImporterBiomedical Internacional
AddressCalle Espana Cochabamba
Boliva, 416 BOLIVIA, PLURINATIONAL STATE OF
Importer TypeRetailer
SubdivisionBO-C
Importing Logistics Registration
ImporterDuphar
AddressNear Old Commune Nyarugenge Kigali
Rwanda, B.P. 1398 RWANDA
Importer TypeRetailer
SubdivisionRW-01
Importing Logistics Registration
ImporterFine Surgical Instruments Inc.
AddressHempstead New York
Hempstead, NY 11550 UNITED STATES
Importer TypeRetailer
Importing Logistics Registration
ImporterGF Health Products Inc.
Address2935 Northeast Parkway Atlanta
ATL, GA 30360 UNITED STATES
Importer TypeRetailer
Importing Logistics Registration
ImporterJorgensen Laboratories Inc.
Address1450 N.Van Buren Avenue Loveland, Colorado
Loveland, CO 80538 UNITED STATES
Importer TypeEnd User
Importing Logistics Registration
ImporterNairobi Enterprise Limited
AddressKikuyu, 00902 Kenya
Kenya, 1462 KENYA
Importer TypeRetailer
SubdivisionKE-110
Importing Logistics Registration
ImporterSinter S.A
AddressDe La rotonda el periodista 100 mts al sur Managua
Nicaragua, 708 NICARAGUA
Importer TypeRetailer
SubdivisionNI-MN
Importing Logistics Registration
ImporterSklar Instruments Corporation
Address889 South Maltlack Street West Chester PA
West Chester, PA 19382 UNITED STATES
Importer TypeRetailer
Importing Logistics Registration
ImporterSupra Latex Pty (Ltd)
Address5 kestrel Park, Longclam Drive Montague Gardens Capeton
South Africa, 1762 SOUTH AFRICA
Importer TypeRetailer
SubdivisionZA-NOTA
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address10 HIGH CT.
LITTLE FALLS, NJ 07424 US
Establishment TypeManufacture Medical Device



Registration Number8039051
FEI Number5638
NameRANDALLE.MCCOY
Owner & OperatorUNIMED S.A.
Contact AddressGRAND-PRE 10 --
LAUSANNE CH-NOTA CH-1007 CH
Official Correspondent
  • Patrick Schoenholzer
  • 41-21-6242151-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address10 HIGH CT.
LITTLE FALLS, NJ 07424 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number9680889
FEI Number1000388472
NameRANDALLE.MCCOY
Owner & OperatorPARAMOUNT SURGIMED LTD.
Contact Address1 LSC, OKHLA INDUSTRIAL AREA OKHLA MAIN RD., PHASE-II
NEW DELHI IN-DL Delhi 110020 IN
Official Correspondent
  • SHAILY - GROVER
  • 91-11-46436600-03
US Agent
Importing Logistics Registration
ImporterEXEL INT INTERNATIONAL CO.
Address5840 W. CENTINELA AVENUE, LOS ANGELES,
Bradley International, CA 90045 UNITED STATES
Importing Logistics Registration
ImporterEXEL International Co.
Address5840 WEST CENTINELA AVENUE
Los Angeles, CA 90045 UNITED STATES
Importing Logistics Registration
ImporterEXELINT INTERNATIONAL CO
Address5840 WEST CENTINELA AVE.
Bradley International, CA 90045 UNITED STATES
Importing Logistics Registration
ImporterMedline Industries, Inc
AddressOne Medline Place
Mundelein, IL 60060 UNITED STATES
Importer TypeRetailer
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address10 HIGH CT.
LITTLE FALLS, NJ 07424 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
RANDALLE.MCCOY [PARAMOUNT SURGIMED LTD.]
Paramount2019-12-10
RANDALLE.MCCOY [PARAMOUNT SURGIMED LTD.]
Paramount2019-08-21
RANDALLE.MCCOY [UNIMED S.A.]
Sedan Side-Cutting Biopsy Needle2018-09-18
RANDALLE.MCCOY [UNIMED S.A.]
Salcman Twist Drill2018-09-18
RANDALLE.MCCOY [UNIMED S.A.]
Insertion Cannula2018-09-18
RANDALLE.MCCOY [UNIMED S.A.]
Injection Aspiration Needle2018-09-18
RANDALLE.MCCOY [UNIMED S.A.]
Backlund Haematoma Evacuator2018-09-18
RANDALLE.MCCOY [UNIMED S.A.]
Backlund Catheter Insertion Needle2018-09-18
RANDALLE.MCCOY [PARAMOUNT SURGIMED LTD.]
Paramount2018-07-10
RANDALLE.MCCOY [UNIMED S.A.]
MicroFrance XOMED INTEGRA2015-04-14
RANDALLE.MCCOY [PARAMOUNT SURGIMED LTD.]
Paramount2014-01-11
RANDALLE.MCCOY [UNIMED S.A.]
Abrams Pleural Biopsy Needle2013-03-13
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
Stretcher, patient restraint2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
Stand, instrument, ophthalmic, battery powered2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
TABLE, EXAMINATION, MEDICAL, POWERED2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
DEVICE, MEDICAL EXAMINATION, AC POWERED2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
Monitor, Bed Patient2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
ABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
Bed, Patient Rotation, Manual2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
AID, TRANSFER2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
APPARATUS, TRACTION, NON-POWERED2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
CABINET, INSTRUMENT, AC-POWERED, OPHTHALMIC2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
STAND, INSTRUMENT, OPHTHALMIC, NON-POWERED2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
TABLE, OPERATING-ROOM, ELECTRICAL2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
CHAIR, SURGICAL, AC-POWERED2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
STOOL, OPERATING-ROOM2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
CHAIR, SURGICAL, NON-ELECTRICAL2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
ACCESSORIES, OPERATING-ROOM, TABLE2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
TABLE, OPERATING-ROOM, NON-ELECTRICAL2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
TABLE, OPERATING-ROOM, MECHANICAL2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
TABLE, OPERATING-ROOM, PNEUMATIC2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
TABLE, OPERATING-ROOM, MANUAL2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
TABLE, OPERATING-ROOM, AC-POWERED2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
Stretcher, Hand-Carried2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
Bed, Hydraulic, Adjustable Hospital2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
Bed Manual2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
Device, Transfer, Patient, Manual2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
TABLE AND ATTACHMENTS, OPERATING-ROOM2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
CABINET, TABLE AND TRAY, ANESTHESIA2011-04-26
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
Stand Infusion, I.V. Stand, Serum Stand2011-04-11
RANDALLE.MCCOY [UNIMED S.A.]
Brockenbrough Transseptal Needle2011-01-25
RANDALLE.MCCOY [UNIMED S.A.]
UNIMED2007-11-19
RANDALLE.MCCOY [UNIMED S.A.]
2R22007-11-19
RANDALLE.MCCOY [PARAMOUNT SURGIMED LTD.]
Paramount2005-06-09
RANDALLE.MCCOY [PARAMOUNT SURGIMED LTD.]
Paramount2005-06-09
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
DRUM WITH LID2005-02-28
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
DRESSING JAR2005-02-28
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
WASH BASIN2005-02-28
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
MIXING BOWL2005-02-28
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
LOTION BOWL2005-02-28
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
GALLIPOT2005-02-28
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
CUP IODINE2005-02-28
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
BUCKET2005-02-28
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
DOUCHE CAN2004-04-21
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
URINAL MALE2004-04-21
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
URINAL FEMALE2004-04-21
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
SPITTEN MUG2004-03-29
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
TRAY W/COVER(CATHETER)2004-03-29
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
SURGICAL TRAY W/O COVER2004-03-29
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
SURGICAL TRAY W/COVER2004-03-29
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
SURGICAL BO2004-03-29
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
IRRIGATOR2004-03-29
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
TRAY INSTRUMENT2004-03-29
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
BEDPAN ROUND2004-03-29
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
BEDPAN PERFECTION2004-03-29
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
BEDPAN FRACTURE TYPE2004-03-29
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
KIDNEY/EMESIS2004-03-29
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
ASIN2004-03-29
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
, TRAY2004-03-29
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
I.R.S.I. LARYNGOSCOPE BLADES1997-03-18
RANDALLE.MCCOY [UNITED POLY ENGINEERING PVT. LTD.]
HANDLES1997-03-18
RANDALLE.MCCOY [PARAMOUNT SURGIMED LTD.]
Paramount1994-12-30
RANDALLE.MCCOY [PARAMOUNT SURGIMED LTD.]
Paramount1994-12-30
RANDALLE.MCCOY [PARAMOUNT SURGIMED LTD.]
Paramount1994-12-30
RANDALLE.MCCOY [UNIMED S.A.]
UNIMED1986-05-27
RANDALLE.MCCOY [UNIMED S.A.]
2R21986-05-27
RANDALLE.MCCOY [UNIMED S.A.]
UNIMED1986-05-27
RANDALLE.MCCOY [UNIMED S.A.]
SUTURA1986-05-27
RANDALLE.MCCOY [UNIMED S.A.]
SUTRANOX1986-05-27

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