FDA Registration Active 🇺🇸 United States

O&M Halyard, Inc.

Reg #: 3014421917 · FEI: 3014421917 · Expires 2026
Products
124
Proprietary Names
240
Establishment Types
5
Classifications
124

Registration Details

Registration Name
O&M Halyard, Inc.
Registration Number
3014421917
FEI Number
3014421917
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
1220 Old Alpharetta Rd Ste 320
City
Alpharetta
State
GA
ZIP
30005
Country
US

Regulatory Submissions

510(k) Number
K171873

Owner / Operator

Firm Name
O&M Halyard, Inc.
Operator Number
10057479
Address
1220 Old Alpharetta Rd, Suite 320
City
Alpharetta
State
GA
Postal Code
30005
Country
US
Correspondent
Angela Bunn

Products

Device Name Product Code
Medical Glove, Specialty LZC
Polymer Patient Examination Glove LZA
Wrap, Sterilization FRG
Wheelchair, Mechanical IOR
Crutch IPR
Mask, Surgical FXX
Saline, Vascular Access Flush NGT
Component, External, Limb, Ankle/Foot ISH
Airway, Oropharyngeal, Anesthesiology CAE
Gown, Surgical FYA
Gastrointestinal Tubes With Enteral Specific Connectors PIF
Tubes, Gastrointestinal (And Accessories) KNT
Fentanyl And Other Opioid Protection Glove QDO
Surgeon'S Gloves KGO
Stirrup, External Brace Component ITC
Vinyl Patient Examination Glove LYZ
Gown, Isolation, Surgical FYC
Splint, Hand, And Components ILH
Clamp, Umbilical HFW
Tube, Aspirating, Flexible, Connecting BYY
Cover, Limb IPM
Syringe, Piston FMF
Needle, Hypodermic, Single Lumen FMI
Drape, Surgical, Antimicrobial KKX
Stretcher, Patient Restraint NZD
Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
Bandage, Elastic FQM
Connector, Catheter GCD
Syringe, Irrigating (Non Dental) KYZ
Device, Intravascular Catheter Securement KMK
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Chamber, Patient Isolation LGM
Electrode, Electrocardiograph DRX
Coverslips, Microscope Slide KES
Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
Respirator, Surgical MSH
Lubricant, Patient KMJ
Pack, Hot Or Cold, Disposable IMD
Tissue Adhesive For The Topical Approximation Of Skin MPN
Latex Patient Examination Glove LYY
Stethoscope, Manual LDE
Stand, Infusion FOX
Tips And Pads, Cane, Crutch And Walker INP
Solvent, Adhesive Tape KOX
Pill Crusher/Cutter OHY
Gauze / Sponge,Nonresorbable For External Use NAB
Catheter, Straight EZD
Band Or Belt, Pelvic Support ISR
Speculum, Vaginal, Nonmetal HIB
Dressing, Wound, Occlusive NAD
Tourniquet, Nonpneumatic GAX
Monitor, Bed Patient KMI
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
Walker, Mechanical ITJ
Electrosurgical, Cutting & Coagulation & Accessories GEI
Trap, Sterile Specimen BYZ
Support, Patient Position CCX
Tray, Surgical, Instrument FSM
System, Thermal Regulating DWJ
Cap, Surgical FYF
Container, Specimen, Non-Sterile NNI
Blood Pressure Cuff DXQ
Gown, Examination FME
Dressing, Wound, Drug FRO
Attachment, Commode, Wheelchair INB
Appliance, Colostomy, Disposable EZS
Pediatric/Child Facemask OXZ
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
Catheters, Suction, Tracheobronchial BSY
Toothbrush, Manual EFW
Container, Specimen, Sterile FMH
Warmer, Irrigation Solution LHC
Indicator, Biological Sterilization Process FRC
Instrument, Surgical, Disposable KDC
Surgical Table Cushion LWG
Catheter, Infusion JCY
Garment, Protective, For Incontinence EYQ
Drape, Adhesive, Aerosol KGT
Container, Specimen Mailer And Storage, Non-Sterile NNK
Non-Surgical Gown OEA
Dressing, Wound, Hydrophilic NAC
Indicator, Physical/Chemical Sterilization Process JOJ
Gauze/Sponge, Internal, X-Ray Detectable GDY
Cover, Shoe, Operating-Room FXP
Suit, Surgical FXO
Bag, Polymeric Mesh, Pacemaker DSW
Percutaneous Replacement Gastrostomy Tube Kit PSH
Bag, Stomal GDS
Container, Liquid Medication, Graduated KYW
Collector, Urine, (And Accessories) For Indwelling Catheter KNX
Bandage, Liquid, Skin Protectant NEC
Sling, Arm ILI
Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
Tape And Bandage, Adhesive KGX
Kit, Surgical Instrument, Disposable KDD
Accessory, Surgical Apparel LYU
Filter, Bacterial, Breathing-Circuit CAH
Cane IPS
Tube, Feeding FPD
Scissors, Umbilical HDJ
Infant Heel Warmer (Chemical Heat Pack) MPO
Recorder, Paper Chart DSF
Holder, Ureteral Catheter EYJ
Curette, Ear JYG
Bag, Ice KYR
Nebulizer (Direct Patient Interface) CAF
Fiber, Medical, Absorbent FRL
Pack, Hot Or Cold, Reusable IME
Device, Paste-On For Incontinence, Sterile EXI
Infusor, Pressure, For I.V. Bags KZD
Catheter And Tip, Suction JOL
Table And Attachments, Operating-Room BWN
Transducer, Ultrasonic, Diagnostic ITX
Aid, Transfer IKX
Basin, Emesis FNY
Shoe And Shoe Cover, Conductive BWP
Continuous Measurement Thermometer FLL
Drape, Surgical, Exempt PUI
Slides, Microscope KEW
General Surgery Tray LRO
System, Blood Collection, Vacuum-Assisted, Manual KST
Bed, Ac-Powered Adjustable Hospital FNL
Bedding, Disposable, Medical KME
Counter, Sponge, Surgical LWH

Proprietary Names

SKYBREEZE* Powder-Free Nitrile Exam Gloves HALYARD® SEQUENTIAL Sterilization Wrap HALYARD® ONE-STEP® Sterilization Wrap HALYARD® QUICK CHECK® Sterilization Wrap HALYARD® SMART-FOLD® Sterilization Wrap YK9000 SERIES MANUAL WHEELCHAIR POLYMER PATIENT EXAM GLOVE CRUTCH Sterling Nitrile Powder-Free Exam Gloves HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops, WrapAround Visor HALYARD Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining HALYARD Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with Visor HALYARD Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor HALYARD Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor HALYARD Fluidshield * 3 Surgical Mask with SO SOFT* Lining HALYARD Fluidshield* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, WrapAround Visor AMSafe(R) Pre-Filled Normal Saline Flush Syringe POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED Personal Stirrup Strap with Slip Ring AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Blue, WrapAround Visor HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Blue PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves Polyisoprene/Neoprene Hybrid Sterile Surgical Glove HALYARD* AQUASOFT ZERO* Nitrile Exam Gloves STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE STERILIZATION WRAP SURGICAL GOWN SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE Tri-Layer AAMI 3 Isolation Gowns SPLINT, HAND AND COMPONENTS Vinyl patient examination glove Obstetric-gynecologic specialized manual instrument (Clamp, Umbilical) TUBE, ASPIRATING, FLEXIBLE, CONNECTING Curaplex® TritonGrip VL™ Nitrile Exam Gloves BASICS* Blue Powder-Free Nitrile Exam Gloves Disposable Powder Free Nitrile Examination Glove, White Color, Tested for Use with Chemotherapy Drugs, Disposable Powder Cover, Limb Needle, hypodermic, single lumen Syringe, piston SURGICAL DRAPE Surgical Packs PATIENT RESTRAINT Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove BANDAGE, ELASTIC POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE FLEXAPRENE GREEN POWDER-FREE EXAM GLOVES SYRINGE, IRRIGATING (NON DENTAL) VINYL PATIENT EXAMINATION GLOVE-POWDER FREE Latex Powder-Free Sterile Surgical Gloves Tested for use with Chemothera STERILIZATION WRAP AND ACCESSORIES Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested With Chemotherapy Drugs Halyard Purple Nitrile* Powder-Free Exam Gloves Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fenta Aero Chrome Select White Powder-Free Nitrile PPE Exam Gloves NITRILE POWDER FREE EXAMINATION GLOVES FLUID CONTROL* Floor Suction Mat Halyard Surgical N95 Respirator Cup Type Small Size Halyard Surgical N95 Respirator Cup Type Regular Size STERILE LUBRICATING JELLY SMART-FOLD Sterilization Wrap HALYARD GOWN Aero Chrome Breathable Performance Surgical Gown DISPOSABLE HOT / COLD PACK FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask LiquiBand Exceed POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF STETHOSCOPE, MANUAL Tips and pads, cane, crutch and walker solvent, adhesive tape Neoprene Micro Powder-Free Sterile Surgical Gloves Procedure Mask Surgical Mask Gauze / sponge,nonresorbable for external use POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE Fetal Monitor Security Strap with Buttonhole Attachment HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED NON-STERILE DISPOSABLE VAGINAL SPECULUM Polyisoprene Powder-Free Sterile Surgical Gloves Dressing, wound, occlusive HALYARD* Non-Bordered Silicone Foam Dressing TOURNIQUET, NONPNEUMATIC Tray, catheterization, sterile urethral, with or without catheter (kit) Walker, mechanical POLYMER PATIENT EXAMINATION GLOVE HALYARD* PUREZERO* Black Nitrile Examination Gloves Foam Patient Positioning TRAY, SURGICAL, INSTRUMENT ASTM Fluid-Rated Procedure Mask HALYARD* STERLING Nitrile Powder-Free Exam Gloves NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS MediChoice THERMAL REGULATING SYSTEM Latex Micro Powder-Free Sterile Surgical Gloves HALYARD* Level 1 Procedure Mask (48388) HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867) Regard® Polyisoprene Powder-Free Sterile Surgical Gloves SURGICAL MASK FLUIDSHIELD* 2 Expanded Chamber Surgical Mask with SO SOFT* Lining, High Clarity WrapAround Visor FLUIDSHIELD* 2 Expanded Chamber Surgical Mask with SO SOFT* Lining SURGICAL CAP Specimen transport and storage container (Container, Specimen, Non-Sterile) Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) EXAMINATION GOWN Evolution AAMI 4 Surgical Gown Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs Impervious Stockinette HALYARD* Xeroform Dressing Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gast HALYARD* Conforming Skin Barrier Ring HALYARD* Skin Barrier Arc One Half Circle HALYARD* Skin Barrier Ostomy Powder Halyard Lavender Nitrile Powder-Free Exam Gloves Regard® Latex Powder-Free Sterile Surgical Gloves FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805) FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802) FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803) Scatter Radiation Drape PEDIATRIC / CHILD FACEMASK POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE EYE SHIELD K160709 CATHETERS, SUCTION, TRACHEOBRONCHIAL Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114) Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116) 62115 HALYARD* FLUIDSHIELD* Level 2 Procedure Mask Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115) CONTAINER, SPECIMEN, STERILE Anti-Fog Surgical Mask FLUID WARMER Sterilization Monitoring Products INSTRUMENT, SURGICAL, DISPOSABLE Halyard Pink Underguard Nitrile Powder-Free Exam Glove HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim SURGICAL TABLE CUSHION Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs TUBE-CONTROL PLUS with Hydrogel HALYARD* Disposable Underpad Sterilization Pouch Heat Seal-Flat Pack Tape Strips HALYARD* SMART-FOLD* Sterilization Wrap (H650) HALYARD* SMART-FOLD* Sterilization Wrap (H450) K823078 FLUIDSHIELD* 2 Procedure Mask with SO SOFT* Earloops FLUIDSHIELD* 2 Fog-Free Procedure Mask with SO SOFT* Earloops, Blue, WrapAround Visor FLUIDSHIELD* 2 Fog-Free Surgical Mask, Blue with Orange Print FLUIDSHIELD* 2 Fog-Free Surgical Mask, Blue with Orange Print, WrapAround Visor FLUIDSHIELD* 2 Procedure Mask with SO SOFT* Earloops, Blue Fluidshield* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Orange AERO BLUE SURGICAL GOWN HALYARD* Gelling Fiber (CMC) Dressing HALYARD* Alginate Dressing GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE OPERATING ROOM SHOE COVER Halyard ONE-STEP Sterilization Wrap PATIENT EXAMINATION GLOVE, SPECIALTY Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) SURGICAL SUIT PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim Telemetry Unit Pouch HALYARD* Lubricating Deodorant Clear Unscented SkyBreeze Zero Nitrile Powder-Free Exam Glove container, liquid medication, graduated HALYARD* STERLING SG* Nitrile Powder-Free Exam Gloves ASTM Fluid-Rated Fog-Free Procedure Mask Bandage, liquid, skin protectant SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE HALYARD* Black Powder-Free Nitrile Exam Gloves Standard Cone Mask sling, arm HALYARD* Regional Anesthesia Pain Management Drape GOWN, DRAPE PACKS SURGICAL DRAPE HALYARD Medical adhesive tape and adhesive bandage (Tape and Bandage, Adhesive) Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves SAFESKIN NITRILE EXAM GLOVE Halyard STERLING* Powder-Free Nitrile Exam Gloves HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) PUREZERO Ultra Violet Nitrile Exam Glove Skybreeze Powder-Free Nitrile Exam Glove Kit, surgical instrument, disposable HALYARD PROCEDURE GOWN ANESTHESIA BREATHING CIRCUIT Gauze/sponge, internal, x-ray detectable TRI-LAYER AAMI3 OVER-THE-HEAD ISOLATION GOWN CANE Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color) Fusion Black Powder-Free Nitrile Exam Glove Nebulizer (direct patient interface) Safe Secure Sterilization Pouches And Rolls HALYARD* Absorbent Table Cover ONE-STEP Sterilization Wrap, QUICK CHECK Sterilization Wrap CATHETER AND TIP, SUCTION STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED OPERATING ROOM TABLE AND ATTACHMENTS VALUESELECT* Film-Reinforced Surgical Gown with Towels VALUESELECT* Standard Surgical Gown with Towels Probe Cover AID, TRANSFER FLUIDSHIELD* 3 Fog-Free Surgical Mask with So Soft* Lining FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops FLUIDSHIELD* 3 Fog-Free Procedure Mask with So Soft* Lining HALYARD* Drawcord Bag, Clear FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868) FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) SHOE AND SHOE COVER Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested For Use With Chemotherapy Drugs And And Fenta Surgical Drape Equipment Covers Surgical Drapes and/or accessories Back Table Covers Halyard Gown Surgical Drapes and/or accessories (Stockinette Drapes) Equipment Drapes Sterisystem Dry-Base Instrument Tray ISOLATION SURGICAL GOWN HALYARD BASICS SURGICAL GOWN General Surgery Tray SURGICAL ISOLATION GOWN Polyisoprene Micro Powder-Free Sterile Surgical Gloves DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869) Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) Aero Blue Performance Surgical Gowns Halyard Anti-Fog Level 1 Tie Mask and Halyard Anti-Fog Level 3 Tie Mask EXAMINATION GLOVE, SPECIALTY DISPOSABLE MEDICAL BEDDING HALYARD ULTRA SURGICAL GOWN Counter, sponge, surgical SKYBREEZE LDP* Powder-Free Nitrile Exam Gloves Halyard Purple Nitrile Max Powder-Free Exam Gloves DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL

Establishment Types

Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Remanufacture Medical Device