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Data / Medical devices / South Korea / Hi Medical Co., Ltd.

Hi Medical Co., Ltd.: FDA-registered device maker in Seoul, South Korea, 32 510(k) clearances

Hi Medical Co., Ltd. is registered with the FDA (registration 3012502601) in Seoul, South Korea. It lists 39 device types. The FDA files 32 510(k) clearances under its listings, the newest dated September 22, 2023. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Hi Medical Co., Ltd.
FDA registration number
3012502601
Address
B-2005, 583, Yangcheon-Ro, Gangseo-Gu, Seoul, South Korea, 07547
Owner or operator
HI MEDICAL CO., LTD. (10052106)
Roles
Exporter to the US
First device listed
June 22, 2016
Registered through
2026
Brand names listed
3M, 3M ESPE, 3M Nexcare, BD, BD Microtainer MAP Microtube for Automated Process, BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, Convatec, Denstply and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Exporter to the USaccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Exporter to the USaccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Exporter to the USaccessdata.fda.gov
Applicator, ResinKXR1Exporter to the USaccessdata.fda.gov
Automated External Defibrillators (Non-Wearable)MKJ3Exporter to the USaccessdata.fda.gov
Bone CementLOD2Exporter to the USaccessdata.fda.gov
Cement, DentalEMA2Exporter to the USaccessdata.fda.gov
Cement, Stomal Appliance, OstomyEZR1Exporter to the USaccessdata.fda.gov
Crown, PreformedELZ1Exporter to the USaccessdata.fda.gov
Dressing, Wound And Burn, OcclusiveMGPUExporter to the USaccessdata.fda.gov
Dressing, Wound, DrugFROUExporter to the USaccessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or BiologicNAE1Exporter to the USaccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Exporter to the USaccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Exporter to the USaccessdata.fda.gov
Holder, Film, X-RayEGZ1Exporter to the USaccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Exporter to the USaccessdata.fda.gov
Irrigator, OstomyEXD2Exporter to the USaccessdata.fda.gov
Liner, Cavity, Calcium HydroxideEJK2Exporter to the USaccessdata.fda.gov
Mask, SurgicalFXX2Exporter to the USaccessdata.fda.gov
Material, ImpressionELW2Exporter to the USaccessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)BSP2Exporter to the USaccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Exporter to the USaccessdata.fda.gov
Protector, OstomyEXE1Exporter to the USaccessdata.fda.gov
Protector, Skin PressureFMP1Exporter to the USaccessdata.fda.gov
Scaler, PeriodonticEMN1Exporter to the USaccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Exporter to the USaccessdata.fda.gov
Suture, Absorbable, NaturalGAL2Exporter to the USaccessdata.fda.gov
Suture, Absorbable, SyntheticGAN2Exporter to the USaccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Exporter to the USaccessdata.fda.gov
Suture, Nonabsorbable, SilkGAP2Exporter to the USaccessdata.fda.gov
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGAQ2Exporter to the USaccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyamideGAR2Exporter to the USaccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Exporter to the USaccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolypropyleneGAW2Exporter to the USaccessdata.fda.gov
Suture, Surgical, Absorbable, PolydioxanoneNEW2Exporter to the USaccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Tube Tracheostomy And Tube CuffJOH2Exporter to the USaccessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 22, 2023K232978DX. Bond V Dental Bonding AdhesiveKLESubstantially EquivalentSino-Dentex Co., Ltd.accessdata.fda.gov
September 2, 2020K193405Simplant Digital GuideNDPSubstantially EquivalentDentsply Sironaaccessdata.fda.gov
January 21, 2016K152926AQUACEL Ag Surgical SP DressingFROSubstantially EquivalentConvatec Limitedaccessdata.fda.gov
February 24, 2015K142296Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner CannulaJOHSubstantially EquivalentCovidienaccessdata.fda.gov
May 5, 2011K111185RELYX LUTING PLUS AUTOMIXEMASubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
April 28, 2011K110105BD PEN NEEDLEFMISubstantially EquivalentBecton, Dickinson and Company (BD)accessdata.fda.gov
September 8, 2010K101249STERIGAGE MODEL 1243RA, 1243RB, 1243REJOJSubstantially Equivalent3M Companyaccessdata.fda.gov
April 8, 2010K094007UNICEMEMASubstantially Equivalent3M Espe AG Dental Productsaccessdata.fda.gov
January 21, 2010K093972BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706JKASubstantially EquivalentBecton, Dickinson & COaccessdata.fda.gov
October 9, 2009K091758BD SPINAL NEEDLE 27GBSPSubstantially EquivalentBecton Dickson & Co.accessdata.fda.gov
July 14, 2006K061037PDS PLUS ANTIBACTERIAL SUTURENEWSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
April 24, 2006K060684ADPER PROMPT, ADPER PROMPT L-POPKLESubstantially Equivalent3M Espe AG Dental Productsaccessdata.fda.gov
March 30, 2005K050106NOVOFINE AUTOCOVER 30G X 8MMFMISubstantially EquivalentNovo Nordisk, Inc.accessdata.fda.gov
May 14, 2004K041071BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381JKASubstantially EquivalentBecton, Dickinson & COaccessdata.fda.gov
September 23, 2003K030902PALACOS RLODSubstantially EquivalentHeraeus Kulzer GmbH & Co. KGaccessdata.fda.gov
November 8, 2002K020715PHILIPS M5066A AND M5068AMKJSubstantially Equivalent - Subject to Tracking Reg.Philips Medical Systemsaccessdata.fda.gov
July 17, 2000K001730GC FUJICEMEMASubstantially EquivalentGC America, Inc.accessdata.fda.gov
April 5, 2000K000629FLEXTIMEELWSubstantially EquivalentHeraeus Kulzer, Inc.accessdata.fda.gov
September 8, 1999K992897IMPREGUM PENTAELWSubstantially EquivalentEspe Dental AGaccessdata.fda.gov
May 28, 1999K991088VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLEJKASubstantially EquivalentBecton Dickinson Vacutainer Systemsaccessdata.fda.gov
November 17, 1997K973262KETAC-FIL APLICAP PLUSEMASubstantially EquivalentEspe GmbH & Co. Kg.accessdata.fda.gov
November 12, 1997K9730363M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRESMGPSubstantially Equivalent for Some Indications3M Healthcareaccessdata.fda.gov
December 18, 1996K964072MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYEDGANSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
May 1, 1996K9553823M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95FXXSubstantially Equivalent3M Companyaccessdata.fda.gov
January 9, 1995K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQSubstantially EquivalentETHICON, Inc.accessdata.fda.gov
July 23, 1992K922721VLC DYCAL IIEJKSubstantially EquivalentDentsply Intl.accessdata.fda.gov
March 6, 1991K904233CONVATEC ABSORBENT BANDAGEEXESubstantially EquivalentConvatec, A Division of E.R. Squibb & Sonsaccessdata.fda.gov
September 28, 1989K895353OPSITE I.V. 3000KGXSubstantially EquivalentSmith & Nephew United, Inc.accessdata.fda.gov
October 31, 1988K881422COE PAK AUTO MIX, REGULAR OR HARD SETEMASubstantially EquivalentCoe Laboratories, Inc.accessdata.fda.gov
August 26, 1983K832299VISI-FLOW IRRIGATOREXDSubstantially EquivalentConvatec, A Division of E.R. Squibb & Sonsaccessdata.fda.gov
February 9, 1983K8132653M STERI-STRIP ANTIMICROBIAL SKIN CLOSKGXSubstantially Equivalent3M Companyaccessdata.fda.gov
March 18, 1980K800485VINYL POLYSILOXANE IMPRESSION MATERIALELWSubstantially Equivalent3M Companyaccessdata.fda.gov

Compare with other makers

Updated September 22, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.