Yolanda Smith

FDA Filings

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

FDA Registration(s)
Registration Number3004579179
FEI Number3004579179
NameYolanda Smith
Owner & OperatorPRIME MEDICAL, INC.
Contact Address395 MADO-RO, MADO-MYEON --
HWASEONG-SHI KR-41 Gyeonggido 445-861 KR
Official Correspondent
  • Hugh Jeong Chang
  • 82-31-3558374-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1468 Harwell Ave
Crofton, MD 21114 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

Registration Number3013514596
FEI Number3013514596
NameYolanda Smith
Owner & OperatorPosdion Co., Ltd
Contact Address452 Yangcheon-ro Room 905, b-dong, Awish-Yedain Building
Gangseo-gu KR-11 Seoul Teugbyeolsi 07574 KR
Official Correspondent
  • Yolanda R Smith
  • 82-2-36642874-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1468 Harwell Ave
Crofton, MD 21114 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

Registration Number3006517653
FEI Number3006517653
NameYolanda Smith
Owner & OperatorCOTTON HIGH TECH S.L.
Contact AddressCtra Navas a Prats de Llussanes, Km 1.5
Gaia ES-B Barcelona ES 08679 ES
Official Correspondent
  • Elena Gomez-Callejon
  • 034-93-8391628-x
US Agent
Importing Logistics Registration
ImporterMERCOLA.COM HEALTH RESOURCES LLC
Address3200 West Higgins Road
Hoffman Est, IL 60169 UNITED STATES
Importer TypeRetailer
Importing Logistics Registration
ImporterPURPLE MOON, LLC d/b/a ORCHIDEA
Address1016 West Jackson Blvd
Chicago, IL 60607 UNITED STATES
Email Addressjeannie@gallucilaw.com
Phone1 312 8782718
Importer TypeDISTRIBUTOR
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1468 Harwell Ave
Crofton, MD 21114 US
Establishment TypeManufacture Medical Device

Registration Number3003595936
FEI Number3003595936
NameYolanda Smith
Owner & OperatorMEDMIRA LABORATORIES, INC.
Contact Address155 CHAIN LAKE DR. SUITE 1
HALIFAX CA-NS Nova Scotia B3S 1B3 CA
Official Correspondent
  • Hermes Chan
  • 1-902-4501588-x
US Agent
Importing Logistics Registration
ImporterMontgomery (NEDC), NY DC
Address500 Neelytown Road
Montgomery, NY 12549 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1468 Harwell Avenue
Crofton, MD 21114 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Yolanda Smith [PRIME MEDICAL, INC.]
Prime Tulle2019-02-04
Yolanda Smith [PRIME MEDICAL, INC.]
Parrafin Gauze Dressing2019-02-04
Yolanda Smith [PRIME MEDICAL, INC.]
Prime Sling2019-02-04
Yolanda Smith [PRIME MEDICAL, INC.]
Prime Collar and Cuff2019-02-04
Yolanda Smith [PRIME MEDICAL, INC.]
PrimeCrepe2019-02-04
Yolanda Smith [PRIME MEDICAL, INC.]
PrimeCOB2019-02-04
Yolanda Smith [PRIME MEDICAL, INC.]
Elstic Securing Bandage2019-02-04
Yolanda Smith [PRIME MEDICAL, INC.]
Elastic Adhesive Bandage2019-02-04
Yolanda Smith [COTTON HIGH TECH S.L.]
Menstrual Cup2017-04-19
Yolanda Smith [Posdion Co., Ltd]
Rextar X2017-02-14
Yolanda Smith [COTTON HIGH TECH S.L.]
Organic Cotton Digital (non-applicator) Tampons Super in Bulk2016-01-21
Yolanda Smith [COTTON HIGH TECH S.L.]
Organic Cotton Digital (non-applicator) Tampons Super Plus in Bulk2016-01-21
Yolanda Smith [COTTON HIGH TECH S.L.]
Organic Cotton Digital (non-applicator) Tampons Regular in Bulk2016-01-21
Yolanda Smith [COTTON HIGH TECH S.L.]
COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS2016-01-21
Yolanda Smith [COTTON HIGH TECH S.L.]
COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS2016-01-21
Yolanda Smith [COTTON HIGH TECH S.L.]
Breast Pads2010-11-12
Yolanda Smith [COTTON HIGH TECH S.L.]
Organic Tampons2009-12-09
Yolanda Smith [COTTON HIGH TECH S.L.]
Organic Cotton Cardboard Applicator Tampons Super in Bulk2009-12-09
Yolanda Smith [COTTON HIGH TECH S.L.]
Organic Cotton Cardboard Applicator Tampons Super Plus in Bulk2009-12-09
Yolanda Smith [COTTON HIGH TECH S.L.]
Organic Cotton Carboard Applicator Tampons Regular in Bulk2009-12-09
Yolanda Smith [COTTON HIGH TECH S.L.]
ORGAT04-ORGAN(Y)C Applicator Tampons Super Plus, bx 14 pcs2009-12-09
Yolanda Smith [COTTON HIGH TECH S.L.]
ORGAT02-ORGAN(Y)C Applicator Tampons Super, bx 14 pcs2009-12-09
Yolanda Smith [COTTON HIGH TECH S.L.]
ORGAT02 -ORGAN(Y)C Applicator Tampons Regular2009-12-09
Yolanda Smith [COTTON HIGH TECH S.L.]
ORGANYC2009-12-09
Yolanda Smith [COTTON HIGH TECH S.L.]
MAXIM Organic Cotton Cardboard Applicator Tampons Super 16ct2009-12-09
Yolanda Smith [COTTON HIGH TECH S.L.]
MAXIM Organic Cotton Cardboard Applicator Tampons Regular 162009-12-09
Yolanda Smith [MEDMIRA LABORATORIES, INC.]
Reveal G4 Rapid HIV-1 Antibody Test2007-12-05
Yolanda Smith [COTTON HIGH TECH S.L.]
PURISTICS2007-10-03
Yolanda Smith [COTTON HIGH TECH S.L.]
Organic Cotton Ultrathin Pantyliners2007-10-03
Yolanda Smith [COTTON HIGH TECH S.L.]
Organic Cotton Ultrathin Pantyliners wrapped individually in Bulk2007-10-03
Yolanda Smith [COTTON HIGH TECH S.L.]
Organic Cotton Ultrathin NIGHT Pads with wings2007-10-03
Yolanda Smith [COTTON HIGH TECH S.L.]
Organic Cotton Ultrathin DAY Pads with wings - wrapped individually - in Bulk2007-10-03
Yolanda Smith [COTTON HIGH TECH S.L.]
Organic Cotton Adaptable Flex Pantyliners HONEST 30u2007-10-03
Yolanda Smith [COTTON HIGH TECH S.L.]
MAXIM2007-10-03
Yolanda Smith [COTTON HIGH TECH S.L.]
MAXIM Ultra Thin, WInged, Unscented, daytime pads2007-10-03
Yolanda Smith [COTTON HIGH TECH S.L.]
MAXIM Ultra Thin, Contour, Unscented, Pantiliners2007-10-03
Yolanda Smith [COTTON HIGH TECH S.L.]
MAXIM Ultra Thin WInged, Unscentedm Overnight Pads2007-10-03
Yolanda Smith [COTTON HIGH TECH S.L.]
MAXIM Straight Unscented, Maternity Pads, Super2007-10-03
Yolanda Smith [COTTON HIGH TECH S.L.]
MAXIM Organic Classic Contour, Unscented Pantiliners2007-10-03
Yolanda Smith [COTTON HIGH TECH S.L.]
MAXIM Natural Cotton Classic Contour Sanitary Pads 16u2007-10-03
Yolanda Smith [COTTON HIGH TECH S.L.]
MAXIM Classic Contour, Unscented Regular Pads2007-10-03
Yolanda Smith [PRIME MEDICAL, INC.]
PrimePor2005-09-20
Yolanda Smith [PRIME MEDICAL, INC.]
PrimeSplint2004-05-28
Yolanda Smith [PRIME MEDICAL, INC.]
PrimeSoft2004-05-28
Yolanda Smith [PRIME MEDICAL, INC.]
PrimePad2004-05-28
Yolanda Smith [PRIME MEDICAL, INC.]
PrimePOP2004-05-28
Yolanda Smith [PRIME MEDICAL, INC.]
PrimeNet2004-05-28
Yolanda Smith [PRIME MEDICAL, INC.]
PrimeCast2004-05-28
Yolanda Smith [MEDMIRA LABORATORIES, INC.]
MedMira H. pylori Test2003-03-21

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U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2018103170476Port Bustamante,Jamaica -> San Juan, Puerto RicoX USED SUZUKI SWIFT MOTOR CAR VIN: ZD11S-404 212 COLOUR: SILVER YEAR OF MANUFACTURE: 20081 UNT
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