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Data / Medical devices / Sweden / Molnlycke Health Care AB

Molnlycke Health Care AB: FDA-registered device maker in Molndal Vastra Gotaland, Sweden, 29 510(k) clearances

Molnlycke Health Care AB is registered with the FDA (registration 3007048057) in Molndal Vastra Gotaland, Sweden. It lists 20 device types. The FDA files 29 510(k) clearances under its listings, the newest dated July 1, 2021. Registered through 2026. FDA data exported November 3, 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 Molnlycke Health Care AB
FDA registration number
3007048057
Address
Entreprenorsstraket 21, Molndal Vastra Gotaland, Sweden, SE-431 53
Owner or operator
MOLNLYCKE HEALTH CARE US LLC (8030877)
Roles
Complaint file establishment, Foreign private label distributor, Specification developer
First device listed
July 24, 1996
Registered through
2026
Brand names listed
ALLDRESS, Avance Solo NPWT System, BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS), Barrier Medical Face Mask, Barrier N95 Particulate Respirator, Barrier Nurse's Cap, Barrier Surgical Cap, Barrier Surgical Hood and more

Devices it lists

DeviceProduct codeClassRoleSource
Bandage, ElasticFQM1Specification developeraccessdata.fda.gov
Cap, SurgicalFYF1Specification developeraccessdata.fda.gov
Device, Transfer, Patient, ManualFMR1Specification developeraccessdata.fda.gov
Dressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicMGQUSpecification developeraccessdata.fda.gov
Dressing, Wound, DrugFROUSpecification developeraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Specification developeraccessdata.fda.gov
Dressing, Wound, OcclusiveNAD1Specification developeraccessdata.fda.gov
Elastomer, Silicone, For Scar ManagementMDA1Specification developeraccessdata.fda.gov
Latex Patient Examination GloveLYY1Specification developeraccessdata.fda.gov
Lift, Patient, Ac-PoweredFNG2Specification developeraccessdata.fda.gov
Lift, Patient, Non-Ac-PoweredFSA1Specification developeraccessdata.fda.gov
Mask, SurgicalFXX2Specification developeraccessdata.fda.gov
Mattress, Flotation Therapy, Non-PoweredIKY1Specification developeraccessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction PumpOMP2Specification developeraccessdata.fda.gov
Protector, Skin PressureFMP1Specification developeraccessdata.fda.gov
Radiation Attenuating Medical GloveOPH1Foreign private label distributoraccessdata.fda.gov
Respirator, SurgicalMSH2Specification developeraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Complaint file establishment, Specification developeraccessdata.fda.gov
Surgeon'S GlovesKGO1Foreign private label distributor, Specification developeraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Specification developeraccessdata.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
July 1, 2021K203369Avance Solo Negative Pressure Wound Therapy (NPWT) SystemOMPSubstantially EquivalentMolnlycke Health Care Us, LLCaccessdata.fda.gov
May 24, 2019K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveKGOSubstantially EquivalentMolnlycke Health Care Us, LLCaccessdata.fda.gov
August 25, 2016K160379Exufiber Ag+FROSubstantially EquivalentMolnlycke Health Care Us, LLCaccessdata.fda.gov
August 31, 2015K150146Biogel PI Micro Indicator UndergloveKGOSubstantially EquivalentMolnlycke Health Care Us, LLCaccessdata.fda.gov
September 4, 2014K141719BIOGEL PL MICRO SURGICAL GLOVEKGOSubstantially EquivalentMolnlycke Health Care Us, LLCaccessdata.fda.gov
February 12, 2014K130040MEPITEL AGFROSubstantially EquivalentMolnlycke Health Careaccessdata.fda.gov
April 5, 2013K123892MEPILEX TRANSFER AGFROSubstantially EquivalentMolnlycke Health Careaccessdata.fda.gov
September 20, 2011K112257BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVEKGOSubstantially EquivalentMolnlycke Health Care Us, LLCaccessdata.fda.gov
November 19, 2010K102923BARRIER N95 PARTICULATE RESPIRATORMSHSubstantially EquivalentMolnlycke Health Careaccessdata.fda.gov
September 15, 2010K100029MEPILEX BORDER AG DRESSINGFROSubstantially EquivalentMolnlycke Health Careaccessdata.fda.gov
August 26, 2008K081180SKINSENSE POLYISOPRENE UNDERGLOVEKGOSubstantially EquivalentMolnlycke Health Care Us, LLCaccessdata.fda.gov
September 11, 2007K071700BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENTKGOSubstantially EquivalentMolnlycke Health Care Us, LLCaccessdata.fda.gov
September 11, 2007K071465BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENTKGOSubstantially EquivalentMolnlycke Health Care Us, LLCaccessdata.fda.gov
September 10, 2007K071565BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENTKGOSubstantially EquivalentMolnlycke Health Care Us, LLCaccessdata.fda.gov
September 10, 2007K071414BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGOSubstantially EquivalentMolnlycke Health Care Us, LLCaccessdata.fda.gov
July 13, 2007K071354MEPILEX AG DRESSINGFROSubstantially EquivalentMonlycke Health Careaccessdata.fda.gov
April 10, 2006K053441BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVEKGOSubstantially EquivalentRegent Medical Americas, LLCaccessdata.fda.gov
March 10, 2006K053102BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVEKGOSubstantially EquivalentRegent Medical Americas, LLCaccessdata.fda.gov
March 7, 2006K053442BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGOSubstantially EquivalentRegent Medical Americas, LLCaccessdata.fda.gov
February 1, 2006K053443BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVEKGOSubstantially EquivalentRegent Medical Americas, LLCaccessdata.fda.gov
August 12, 2005K050899BIOGEL LATEX STERILE POWDER-FREE GLOVEKGOSubstantially EquivalentRegent Medical Americas, LLCaccessdata.fda.gov
March 16, 2005K050184BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVEKGOSubstantially EquivalentRegent Medical Americas, LLCaccessdata.fda.gov
August 14, 2000K000421BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVEKGOSubstantially EquivalentSsl Americas, Inc. (Regent Medical)accessdata.fda.gov
February 22, 1999K984368NORMLGEL 0.9% ISOTONIC SALINE GELMGQSubstantially EquivalentMolnlycke Health Care, Inc.accessdata.fda.gov
October 29, 1997K971514REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVELYYSubstantially EquivalentLondon International Group, Inc.accessdata.fda.gov
March 28, 1994K934194BARRIER LASER PLUS FACE MASKFXXSubstantially EquivalentJohnson & Johnson Medical, Inc.accessdata.fda.gov
February 10, 1994K920108BARRIER EXTRA PROTECTION PLUS FACE MASKFXXSubstantially EquivalentJohnson & Johnson Medical, Inc.accessdata.fda.gov
April 29, 1991K910557BARRIER* EXTRA PROTECTION PLUS FACE MASKFXXSubstantially EquivalentJohnson & Johnson Medical, Inc.accessdata.fda.gov
March 21, 1988K875107HEALTH CARE EYE PROTECTIONHOYSubstantially EquivalentSurgikos, Inc.accessdata.fda.gov

Compare with other makers

Updated July 1, 2021. 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.