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Data / Medical devices / United States / Hu-Friedy MFG. Co. LLC

Hu-Friedy MFG. Co. LLC: FDA-registered device maker in Northbrook, IL, United States, 30 510(k) clearances

Hu-Friedy MFG. Co. LLC is registered with the FDA (registration 1416605) in Northbrook, IL, United States. It lists 74 device types. The FDA files 30 510(k) clearances under its listings, the newest dated May 9, 2025. 3 recall events name it as the recalling firm. Registered through 2027. 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 Hu-Friedy MFG. Co. LLC
FDA registration number
1416605
Address
2501 Sanders Rd, Northbrook, IL, United States, 60062
Owner or operator
Hu-Friedy Mfg Co., LLC (1416605)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
December 12, 1977
Registered through
2027
Brand names listed
AMALGAM AND FOIL, AMALGAM CARVERS, AMALGAM PLUGGERS, After Five, After Five Plus, Cartridge Syringe, ConFirm Rapid 20 Biological Indicator, ConFirm Rapid 20 Incubator and more

Devices it lists

DeviceProduct codeClassRoleSource
Agent, Polishing, Abrasive, Oral CavityEJR1Repackager or relabeleraccessdata.fda.gov
AirbrushKOJ2Repackager or relabeleraccessdata.fda.gov
Bar, PreformedEHO1Repackager or relabeleraccessdata.fda.gov
Bath, Incubators/Water, AllJTQ1Repackager or relabeleraccessdata.fda.gov
Blade, ScalpelGES1Repackager or relabeleraccessdata.fda.gov
Bone MillLYS1Manufactureraccessdata.fda.gov
Bur, DentalEJL1Repackager or relabeleraccessdata.fda.gov
Burnisher, OperativeEKJ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Carrier, LigatureGEJ1Manufactureraccessdata.fda.gov
Carver, Dental Amalgam, OperativeEKH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Chisel, Bone, SurgicalEML1Manufactureraccessdata.fda.gov
Clamp, Rubber DamEEF1Manufactureraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Repackager or relabeleraccessdata.fda.gov
Condenser, Amalgam And Foil, OperativeEKG1Manufactureraccessdata.fda.gov
Crown, PreformedELZ1Repackager or relabeleraccessdata.fda.gov
Curette, PeriodonticEMS1Manufactureraccessdata.fda.gov
Curette, Surgical, DentalEMK1Manufactureraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Excavator, Dental, OperativeEKC1Manufactureraccessdata.fda.gov
Explorer, OperativeEKB1Manufactureraccessdata.fda.gov
File, Bone, SurgicalEMI1Manufacturer, Repackager or relabeleraccessdata.fda.gov
File, Margin Finishing, OperativeEKA1Manufactureraccessdata.fda.gov
File, PeriodonticEMR1Manufactureraccessdata.fda.gov
Forceps, Articulation PaperEFK1Specification developeraccessdata.fda.gov
Forceps, Dressing, DentalEFL1Specification developeraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Specification developeraccessdata.fda.gov
Forceps, Rubber Dam ClampEJG1Manufacturer, Specification developeraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Manufacturer, Specification developeraccessdata.fda.gov
Gag, MouthKBN1Repackager or relabeler, Specification developeraccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Manufactureraccessdata.fda.gov
Handle, Instrument, DentalEJB1Manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Manufactureraccessdata.fda.gov
Hemostat, SurgicalEMD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Hoe, PeriodonticEMQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Specification developeraccessdata.fda.gov
Indicator, Biological Sterilization ProcessFRC2Repackager or relabeleraccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Instrument, Cutting, OperativeEKD1Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Manufactureraccessdata.fda.gov
Instrument, Ligature Tucking, OrthodonticECP1Manufactureraccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Manufactureraccessdata.fda.gov
Knife, Margin Finishing, OperativeEJZ1Manufactureraccessdata.fda.gov
Knife, PeriodonticEMO1Manufactureraccessdata.fda.gov
Knife, SurgicalEMF1Manufactureraccessdata.fda.gov
MalletHXL1Manufactureraccessdata.fda.gov
Marker, PeriodonticEMP1Manufactureraccessdata.fda.gov
Mirror, MouthEAX1Manufactureraccessdata.fda.gov
Non-Surgical GownOEA1Repackager or relabeleraccessdata.fda.gov
Osteotome, ManualGFI1Manufacturer, Specification developeraccessdata.fda.gov
Plier, OrthodonticJEX1Contract manufacturer, Manufactureraccessdata.fda.gov
Pliers, OperativeEJY1Manufacturer, Specification developeraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Probe, PeriodonticEIX1Manufactureraccessdata.fda.gov
Pusher, Band, OrthodonticECS1Manufactureraccessdata.fda.gov
Remover, CrownEIS1Manufactureraccessdata.fda.gov
Retractor, All TypesEIG1Manufacturer, Specification developeraccessdata.fda.gov
Scaler, PeriodonticEMN1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Scaler, UltrasonicELC2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Scissors, Collar And CrownEIR1Specification developeraccessdata.fda.gov
Scissors, Surgical Tissue, DentalEGN1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Spatula, Surgical, General & Plastic SurgeryGAF1Manufactureraccessdata.fda.gov
Spreader, Pulp Canal Filling Material, EndodonticEKK1Manufactureraccessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesKCT2Repackager or relabeleraccessdata.fda.gov
Suture, Absorbable, NaturalGAL2Repackager or relabeleraccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, SilkGAP2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolypropyleneGAW2Repackager or relabeleraccessdata.fda.gov
Suture, Surgical, Nonabsorbable, Expanded, PolytetraflouroethyleneNBY2Repackager or relabeleraccessdata.fda.gov
Syringe, CartridgeEJI2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Syringe, Irrigating (Dental)EIB1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufacturer, Specification developeraccessdata.fda.gov
Wire, OrthodonticDZC1Repackager or relabeleraccessdata.fda.gov
Wrap, SterilizationFRG2Repackager or relabeleraccessdata.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
May 9, 2025K251425turbodent touchKOJSubstantially EquivalentMectron S.P.A.accessdata.fda.gov
December 15, 2023K233681ConFirm 20 Minute IncubatorFRCSubstantially EquivalentSTERIS Corporationaccessdata.fda.gov
May 15, 2023K231391Combi TouchELCSubstantially EquivalentMectron S.P.A.accessdata.fda.gov
January 21, 2022K213412VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CMJOJSubstantially EquivalentSteris Corparationaccessdata.fda.gov
August 2, 2019K191741Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization TapeJOJSubstantially EquivalentIntertape Polymer, Inc.accessdata.fda.gov
July 24, 2018K181686CELERITY 20 Steam Biological IndicatorFRCSubstantially EquivalentSTERIS Corporationaccessdata.fda.gov
February 22, 2018K171823U&U Indicator tape and stripJOJSubstantially EquivalentU&U Medical Technology Co, Ltd.accessdata.fda.gov
June 28, 2016K161024Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization TapeJOJSubstantially EquivalentCanadian Technical Tape, Ltd.accessdata.fda.gov
August 20, 2014K140965MULTIPIEZO PRO, MULTIPIEZOELCSubstantially EquivalentMectron S.P.A.accessdata.fda.gov
February 12, 2014K132464PTFE SURGICAL SUTURENBYSubstantially EquivalentOmnia Spaaccessdata.fda.gov
July 5, 2013K123234ERMIS STERILIZATION CONTAINER SYSTEMKCTSubstantially EquivalentErmis Medizintechnikaccessdata.fda.gov
November 6, 2012K120659HU-FRIEDY DENTAL CARTRIDGE SYRINGEEJISubstantially EquivalentHu-Friedy Mfg. Co., LLCaccessdata.fda.gov
March 30, 2010K100401SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEMELCSubstantially EquivalentHu-Friedy Mfg. Co., Inc.accessdata.fda.gov
July 17, 2007K070428MEDICOM SELF-SEALING STERILIZATION POUCHKCTSubstantially EquivalentA.R. Medicom, Inc.accessdata.fda.gov
June 21, 2007K070975SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIESELCSubstantially EquivalentHu-Friedy Mfg. Co., Inc.accessdata.fda.gov
February 1, 2006K053178SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPSELCSubstantially EquivalentHu-Friedy Mfg. Co., Inc.accessdata.fda.gov
October 3, 2005K052516STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137JOJSubstantially EquivalentSteritec Products, Inc.accessdata.fda.gov
October 25, 2002K022706SPSMEDICAL SPORVIEW STEAM BI TEST PACKFRCSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
January 28, 2002K014021SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYEDGAMSubstantially EquivalentSurgical Specialties Corpaccessdata.fda.gov
July 27, 2001K012060MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERTELCSubstantially EquivalentHu-Friedy Mfg. Co., Inc.accessdata.fda.gov
February 12, 1997K965162LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.GAMSubstantially EquivalentLukens Medical Corp.accessdata.fda.gov
October 7, 1995K953919DENTAL ULTRASONIC SCALER INSERTSELCSubstantially EquivalentHu-Friedy Mfg. Co., Inc.accessdata.fda.gov
January 7, 1994K930826SUTURE NONABSORBABLE - SILKGAPSubstantially EquivalentSurgical Specialties, Inc.accessdata.fda.gov
December 24, 1990K904906SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USPGAWSubstantially EquivalentChathamborough Research Group, Inc.accessdata.fda.gov
May 31, 1990K896554GUT SUTURESGALSubstantially Equivalent for Some IndicationsLook, Inc.accessdata.fda.gov
August 7, 1989K890755SEALING TAPE, STERILIZATION INDICATOR; STEAMJOJSubstantially EquivalentSpsmedical Supply Corp.accessdata.fda.gov
March 31, 1988K875193INDISTRIP (STERILIZATION PROCESS INDICATOR)JOJSubstantially EquivalentIndilab, Inc.accessdata.fda.gov
November 8, 1984K844002HU-FRIEDY IMS CASSETTE SYSTEMFSMSubstantially EquivalentHu-Friedy Mfg. Co., Inc.accessdata.fda.gov
June 2, 1983K831425MDT CHEMITEST SEE-THRU BAGFRGSubstantially EquivalentKenpak Converters, Inc.accessdata.fda.gov
February 13, 1980K800123DEXTEX II STERILIZATION WRAPFRGSubstantially EquivalentAhlstrom Dexteraccessdata.fda.gov

Recalls

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

InitiatedEventClassStatusProductReasonSource
January 7, 200530882Not yet classifiedTerminatedDental Explorer #2 D/E, Mfr. Part Code/Product Code, distributed under the Henry Schein label. Classification Name: 21CFR; 510(k) exempt, Class I device, Device Listing # B057701. Product is labeled in part, HENRY SCHEINPotential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification setter of the dental explorers.accessdata.fda.gov
March 29, 200428672Not yet classifiedTerminatedHENRY SCHEIN(R) Explorer #2 D/E. Barcode *+H658101091306*. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter). Investigation conducted by Hu-Friedy Mfg. Co. revealed that the tips of the instruments may have been improperly heat treated and have the potential for unexpected tip fracture.accessdata.fda.gov
April 10, 200325958Not yet classifiedTerminatedNon-Sterile Suture Needles, Reverse Cutting, 1/2 Circle, Stainless Steel; 12 suture needles per glass vial; partcode: SN4; Hu-Friedy Mfg. Co., Inc., 3232 N. Rockwell St., Chicago, IL 60618The suture needles were mislabeled with the wrong size.accessdata.fda.gov

Compare with other makers

Updated May 9, 2025. 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.