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Data / Medical devices / United States / Freudenberg Medical, LLC

Freudenberg Medical, LLC: FDA-registered device maker in Carpinteria, CA, United States, 14 510(k) clearances

Freudenberg Medical, LLC is registered with the FDA (registration 2025182) in Carpinteria, CA, United States. It lists 17 device types. The FDA files 14 510(k) clearances under its listings, the newest dated December 18, 2024. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Freudenberg Medical, LLC
FDA registration number
2025182
Address
1110 Mark Ave, Carpinteria, CA, United States, 93013
Owner or operator
Freudenberg Medical, LLC (2025182)
Roles
Contract manufacturer, Manufacturer, Specification developer
First device listed
July 24, 1998
Registered through
2026
Brand names listed
Blom-Singer Cleaning Brush, Blom-Singer Duckbill Voice Prosthesis, StageOne Knee Cement Spacer Mold, StageOne Knee Femoral Cement Spacer Mold, M/L 60mm, A/P 43mm, StageOne Knee Femoral Cement Spacer Mold, M/L 65mm, A/P 48mm, StageOne Knee Femoral Cement Spacer Mold, M/L 70mm, A/P 52mm, StageOne Knee Femoral Cement Spacer Mold, M/L 75mm, A/P 57mm, StageOne Knee Tibial Cement Spacer Mold, M/L 65mm, A/P 39mm and more

Devices it lists

DeviceProduct codeClassRoleSource
Applicator, Absorbent Tipped, Non-SterileKXF1Specification developeraccessdata.fda.gov
Bone Cement, AntibioticMBB2Contract manufactureraccessdata.fda.gov
Brush, Cleaning, Tracheal TubeEPE1Manufactureraccessdata.fda.gov
Button, Nasal SeptalLFBUManufactureraccessdata.fda.gov
Catheter, NasopharyngealENW1Manufactureraccessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)BYD1Contract manufacturer, Manufactureraccessdata.fda.gov
Dilator, TrachealKCG1Manufactureraccessdata.fda.gov
Gauge, MeasuringJYJ1Manufacturer, Specification developeraccessdata.fda.gov
Implant, Absorbable, (Scleral Buckling Methods)HQJ2Contract manufactureraccessdata.fda.gov
Instrument, Ent Manual SurgicalLRC1Manufactureraccessdata.fda.gov
Kit, Surgical Instrument, DisposableKDD1Contract manufactureraccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Contract manufactureraccessdata.fda.gov
Prosthesis, Laryngeal (Taub)EWL2Manufactureraccessdata.fda.gov
Snare, NasalKBE1Specification developeraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Specification developeraccessdata.fda.gov
Tray, Surgical, EntMMO1Manufactureraccessdata.fda.gov
Tube, LaryngectomyKAC1Manufactureraccessdata.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
December 18, 2024K240763FirstFit Surgical KitEWLSubstantially EquivalentFreudenberg Medical, LLCaccessdata.fda.gov
December 17, 2013K130736BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESISLRCSubstantially EquivalentHelix Medical, LLCaccessdata.fda.gov
September 17, 2013K131745BLOM-SINGER SEPTAL PERFORATION PROSTHESISLFBSubstantially EquivalentHelix Medical, LLCaccessdata.fda.gov
March 3, 2010K093258BLOM-SINGER INDWELLING TEP OCCLUDEREWLSubstantially EquivalentHelix Medical, LLCaccessdata.fda.gov
September 4, 2008K082206BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIESEWLSubstantially EquivalentHelix Medical, LLCaccessdata.fda.gov
June 25, 1999K991587BLOM-SINGER INDWELLING 2000 VOICE PROSTHESISEWLSubstantially EquivalentHelix Medical, Inc.accessdata.fda.gov
December 2, 1994K945288INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICEEWLSubstantially EquivalentHelix Medical, Inc.accessdata.fda.gov
April 15, 1994K932120BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHESEWLSubstantially EquivalentHelix Medical, Inc.accessdata.fda.gov
December 15, 1993K932163BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPETEWLSubstantially EquivalentHelix Medical, Inc.accessdata.fda.gov
May 17, 1993K930105BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.EWLSubstantially EquivalentHelix Medical, Inc.accessdata.fda.gov
September 10, 1992K920090BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SETEWLSubstantially EquivalentHelix Medical, Inc.accessdata.fda.gov
February 28, 1991K904729BLOM-SINGER SHOWER GUARDEWLSubstantially EquivalentHelix Medical, Inc.accessdata.fda.gov
July 22, 1985K851082V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TESENWSubstantially EquivalentAmerican V. Muelleraccessdata.fda.gov
March 25, 1980K800563BLOM-SINGER DUCKBILL VOICE PROSTHESISEWLSubstantially EquivalentBivona Medical Technologiesaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
June 17, 202699299Class IIOngoingBlom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEFIncorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.accessdata.fda.gov
October 1, 201366423Class IIITerminatedBlom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging. The ATSV II Valve product cannot be used as intended without the product body.accessdata.fda.gov
March 8, 201262970Class IIITerminatedBLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoHelix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.accessdata.fda.gov

Compare with other makers

Updated August 6, 2026. 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.