Halyard Health
Alpharetta, GA, US
Halyard Health appears in FDA device records in Alpharetta, GA. FDA records list 96 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 147 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
6 namesFDA records resolved to Halyard Health carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Avanos Medical, Inc.registration, 510(k), enforcement report, recall
- Corpak Med Systemsrecall
- Corpak Medsystems510(k), enforcement report, recall
- I-Flow, LLC510(k), enforcement report, recall
- Neomed, Inc.registration, 510(k), enforcement report, recall
- VIASYS Med Systemsrecall
510(k) clearance history
Showing 50 of 96FDA records hold 96 510(k) clearances for Halyard Health between 1978 and 2025. The busiest year on record is 1999, with 10. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 2 |
| 1979 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 2 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 6 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 10 |
| 2000 | 1 |
| 2002 | 7 |
| 2004 | 1 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 5 |
| 2009 | 5 |
| 2010 | 3 |
| 2012 | 3 |
| 2013 | 1 |
| 2014 | 4 |
| 2015 | 5 |
| 2016 | 6 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 2 |
| 2022 | 1 |
| 2024 | 3 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243572 | Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La | IRP | Substantially Equivalent | |
| K241185 | CORGRIP* SR NG/NI Tube Retention System | KNT | Substantially Equivalent | |
| K242057 | COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) | GXD | Substantially Equivalent | |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950) | KNT | Substantially Equivalent | |
| K220588 | Avanos* CORTRAK* 2 Enteral Access System (EAS) | KNT | Substantially Equivalent | |
| K203066 | COOLIEF Cooled Radiofrequency Kit Advanced | GXI | Substantially Equivalent | |
| K192491 | Coolief Radiofrequency Generator (CRG) System | GXD | Substantially Equivalent | |
| K191340 | CORTRAK* 2 Equilateral Enteral Access System | KNT | Substantially Equivalent | |
| K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) | PNR | Substantially Equivalent | |
| K181360 | ON-Q* Pump with Bolus | MEB | Substantially Equivalent | |
| K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | |
| K173955 | Mic-Key* SF Over-the-Wire Stoma Measuring Device | KNT | Unknown | |
| K162930 | Aero Chrome* Select Breathable Performance Surgical Gowns | FYA | Substantially Equivalent | |
| K163461 | Coolief* Cooled RF Probe | GXI | Substantially Equivalent | |
| K163236 | COOLIEF Cooled Radiofrequency Kit | GXI | Substantially Equivalent | |
| K161232 | ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit | BSO | Substantially Equivalent | |
| K160709 | HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves | LZC | Substantially Equivalent | |
| K161039 | NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) | PNR | Substantially Equivalent | |
| K153255 | Aero Chrome* Breathable Performance Surgical Gown | FYA | Substantially Equivalent | |
| K153708 | Halyard Black-Orange Powder-Free Nitrile Exam Glove | LZA | Substantially Equivalent | |
| K152857 | NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps | PNR | Substantially Equivalent | |
| K150113 | Fusion Black Powder-Free Nitrile Exam Glove | LZA | Substantially Equivalent | |
| K143344 | NeoMed NeoConnect Enteral Syringes with ENFit Connector | PNR | Substantially Equivalent | |
| K143287 | Fluidshield* Surgical Mask with Expanded Chamber | FXX | Substantially Equivalent | |
| K143095 | MiniStim MS-IVB Peripheral Nerve Stimulator | BXN | Substantially Equivalent | |
| K141712 | KIMGUARD ONE STEP STERILIZATION WRAP | FRG | Substantially Equivalent | |
| K142012 | FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS | PIF | Substantially Equivalent | |
| K133599 | CORGRIP | KNT | Substantially Equivalent | |
| K131249 | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES | MEB | Substantially Equivalent | |
| K131532 | ELECTROMAGNETIC TRANSMITTING STYLET | KNT | Substantially Equivalent | |
| K122373 | NEOMED ORAL/ENTERAL SYRINGE | FMF | Substantially Equivalent | |
| K120182 | NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES | KNT | Substantially Equivalent | |
| K113351 | CORTRAK ENTERAL ACCESS DEVICE | KNT | Substantially Equivalent | |
| K100288 | NEOMED ENTERAL ONLY EXTENSION SET | KNT | Substantially Equivalent | |
| K100365 | FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV | KNT | Substantially Equivalent | |
| K092908 | NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO | FMF | Substantially Equivalent | |
| K091637 | CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 | KNT | Substantially Equivalent | |
| K083776 | CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S | FPD | Substantially Equivalent | |
| K083791 | CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S | FPD | Substantially Equivalent | |
| K083786 | CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB | FPD | Substantially Equivalent | |
| K083121 | NEO MAPCATH SENSOR STYLET | OMF | Substantially Equivalent | |
| K083210 | CORFLO ANTI IV ENTERAL FEEDING TUBE | FPD | Substantially Equivalent | |
| K082238 | NEOMED POLYURETHANE FEEDING TUBE | FPD | Substantially Equivalent | |
| K081515 | NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 | FOS | Substantially Equivalent | |
| K073596 | NEOMED SINGLE LUMEN UMBILICAL CATHETER | FOS | Substantially Equivalent | |
| K072881 | NEOMED Enteral FEEDING TUBE | FPD | Substantially Equivalent | |
| K072997 | NEOMED URINARY CATHETER | EZD | Substantially Equivalent | |
| K063530 | ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP | MEB | Substantially Equivalent | |
| K063234 | ON-Q INTRODUCERS | BSO | Substantially Equivalent | |
| K051401 | ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER | BSO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011270181 | 3011270181 | Avanos Medical, Inc. | 5405 Windward Parkway, Alpharetta, GA 30004 US | 2026 | and 51 more, listed in full below |
| 3012865799 | 3012865799 | NEOMED CO., LTD. | 20, Jangnim-ro 196beon-gil, Saha-gu Busan 49475 KR | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CAZAnesthesia Conduction Kit
- CACApparatus, Autotransfusion
- HAMApparatus, Electrosurgical
- FQMBandage, Elastic
- KMEBedding, Disposable, Medical
- KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
- JOLCatheter And Tip, Suction
- BSOCatheter, Conduction, Anesthetic
- EZDCatheter, Straight
- FOSCatheter, Umbilical Artery
- GBMCatheter, Urethral
- BSYCatheters, Suction, Tracheobronchial
- HXDClamp
- FFNClamp, Non-Electrical
- HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)
- BYDCondenser, Heat And Moisture (Artificial Nose)
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- FDXEndoscopic Cytology Brush
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- FFDEvacuator, Bladder, Manually Operated
- KGEForceps, Biopsy, Electric
- GXDGenerator, Lesion, Radiofrequency
- FMEGown, Examination
- FYAGown, Surgical
- IRSHead Halter, Traction
- ITWJoint, Ankle, External Brace
- GCJLaparoscope, General & Plastic Surgery
- FXXMask, Surgical
- IRPMassager, Powered Inflatable Tube
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- IQKOrthosis, Cervical
- IQIOrthosis, Limb Brace
- IQEOrthosis, Lumbar
- IMDPack, Hot Or Cold, Disposable
- ILOPack, Hot Or Cold, Water Circulating
- HMPPad, Eye
- BYIPercussor, Powered-Electric
- GXIProbe, Radiofrequency Lesion
- EXEProtector, Ostomy
- FRNPump, Infusion
- FPASet, Administration, Intravascular
- ILISling, Arm
- FDISnare, Flexible
- IQJSplint, Clavicle
- BXNStimulator, Nerve, Battery-Powered
- ILGStocking, Elastic
- IOYSupport, Arm
- FMFSyringe, Piston
- BWNTable And Attachments, Operating-Room
- KGXTape And Bandage, Adhesive
- FTYTape, Measuring, Rulers And Calipers
- EFWToothbrush, Manual
- FPDTube, Feeding
- KGCTube, Gastro-Enterostomy
- BSSTube, Nasogastric
- BTRTube, Tracheal (W/Wo Connector)
- ILCUtensil, Eating
- BTMVentilator, Emergency, Manual (Resuscitator)
- FRGWrap, Sterilization
Recall records
Showing 25 of 147| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2352-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2351-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2350-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2349-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2348-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2347-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Product Description: Feeding Tube Kit Component: No | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2346-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2345-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2344-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2343-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2342-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2341-2026 | Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2340-2026 | Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2339-2026 | Product Name: CORFLO* Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6312 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2338-2026 | Product Name: CORFLO* Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-5320 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2337-2026 | Product Name: CORFLO* Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-4320 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2336-2026 | Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2335-2026 | Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2334-2026 | Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-2333-2026 | Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Class II | Open, Classified | |
| Z-1528-2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A | Lack of sterility assurance for closed suction catheter systems | Class I | Open, Classified | |
| Z-1527-2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE Component: N/A | Lack of sterility assurance for closed suction catheter systems | Class I | Open, Classified | |
| Z-1526-2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A | Lack of sterility assurance for closed suction catheter systems | Class I | Open, Classified | |
| Z-1525-2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N/A | Lack of sterility assurance for closed suction catheter systems | Class I | Open, Classified | |
| Z-1524-2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Component: N/A | Lack of sterility assurance for closed suction catheter systems | Class I | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain