FDA Registration
Active
🇺🇸 United States
MEDICAL ACTION INDUSTRIES, INC. 306
Reg #: 1030451
·
FEI: 1030451
·
Expires 2026
Products
120
Proprietary Names
193
Establishment Types
3
Classifications
120
Registration Details
- Registration Name
- MEDICAL ACTION INDUSTRIES, INC. 306
- Registration Number
- 1030451
- FEI Number
- 1030451
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 25 HEYWOOD RD.
- City
- ARDEN
- State
- NC
- ZIP
- 28704
- Country
- US
Regulatory Submissions
- 510(k) Number
- K971645
Owner / Operator
- Firm Name
- O & M Halyard, Inc.
- Operator Number
- 10039033
- Address
- 1220 Old Alpharetta Rd. Ste 320
- City
- Alpharetta
- State
- GA
- Postal Code
- 30005
- Country
- US
- Correspondent
- Angela L Bunn
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hysterectomy Kit | OJF | Class 2 | Obstetrics/Gynecology | No | 2024-09-03 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2015-08-17 |
| Plastic Surgery And Accessories Kit | FTN | Class 1 | General, Plastic Surgery | No | 2015-08-17 |
| General Purpose Dental Tray | OFX | Class 1 | Dental | No | 2015-08-14 |
| Spinal Epidural Anesthesia Kit | OFT | Class 2 | Anesthesiology | No | 2015-08-14 |
| Wound Dressing Kit | MCY | Class 2 | General Hospital | No | 2015-08-14 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2015-08-14 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2015-08-17 |
| Single Use Instrument Tray | OJV | Class 1 | General, Plastic Surgery | No | 2015-08-14 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2015-08-14 |
| Catheter Care Tray | OHR | Class 2 | Gastroenterology, Urology | No | 2015-08-14 |
| Body Fluids Barrier Kit | OKH | Class 2 | General, Plastic Surgery | No | 2015-08-14 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2015-08-14 |
| Central Venous Catheter Dressing Change Kit | PEZ | Class 2 | General Hospital | No | 2015-08-14 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-07-21 |
| Angiography/Angioplasty Kit | OEQ | Class 2 | Cardiovascular | No | 2024-09-24 |
| Port Introducer Kit | OKE | Class 2 | General Hospital | No | 2016-04-01 |
| Burn Kit Without Drug | OJJ | Class 1 | General, Plastic Surgery | No | 2015-08-14 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2017-05-24 |
| Neurological Tray | OJG | Class 1 | Neurology | No | 2015-08-20 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2015-08-17 |
| Needle, Spinal, Short Term | MIA | Class 2 | Anesthesiology | No | 2016-08-23 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2014-03-06 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2016-03-15 |
| Catheter Introducer Kit | OFD | Class 2 | Cardiovascular | No | 2015-08-14 |
| Body Fluid Clean Up Kit | OKG | Class 2 | General, Plastic Surgery | No | 2015-08-14 |
| Clamp, Circumcision | HFX | Class 2 | Obstetrics/Gynecology | No | 2020-12-04 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2016-11-02 |
| Laparoscopy Kit | FDE | Class 2 | Gastroenterology, Urology | No | 2021-08-19 |
| Orthopedic Tray | OJH | Class 1 | General, Plastic Surgery | No | 2015-08-20 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2015-08-14 |
| Anesthesia Kit | OFQ | Class 2 | Anesthesiology | No | 2024-09-24 |
| Central Venous Catheter Tray | OFF | Class 2 | Cardiovascular | No | 2015-08-14 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2015-08-14 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2015-08-14 |
| D And C Tray | PKF | Class N | Unknown | No | 2024-09-24 |
| Cardiac Catheterization Kit | OES | Class 2 | Cardiovascular | No | 2016-06-22 |
| Urine Collection Kit (Excludes Hiv Testing) | OIE | Class 1 | Pathology | No | 2015-08-14 |
| Gynecological Laparoscopic Kit | OHD | Class 2 | Obstetrics/Gynecology | No | 2024-07-22 |
| Skin Prep Tray | OJU | Class 1 | General, Plastic Surgery | No | 2015-08-14 |
| Decontamination Kit | MAC | Class 1 | General, Plastic Surgery | No | 2015-08-14 |
| Ear, Nose, And Throat Surgical Tray | OGR | Class 1 | Ear, Nose, Throat | No | 2024-09-03 |
| Tray, Start/Stop (Including Contents), Dialysis | FKG | Class 1 | Gastroenterology, Urology | No | 2015-08-14 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2015-12-03 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2015-08-14 |
| Epidural Anesthesia Kit | OGE | Class 2 | Anesthesiology | No | 2024-09-24 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2020-05-01 |
| Labor And Delivery Kit | MLS | Class 2 | Obstetrics/Gynecology | No | 2015-08-14 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2016-08-18 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2016-08-18 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2022-07-27 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2015-08-14 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2015-11-24 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2021-07-22 |
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2015-08-20 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2015-08-17 |
| Blood Specimen Collection Kit (Excludes Hiv Testing) | OFZ | Class 1 | Anesthesiology | No | 2015-08-14 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2016-08-18 |
| Nerve Block Tray | OGJ | Class 2 | Anesthesiology | No | 2015-08-14 |
| Peripheral Catheter Insertion Kit | OWL | Class 2 | General Hospital | No | 2015-08-14 |
| Chemotherapy Spill Clean-Up Kit | PWT | Class 1 | General Hospital | No | 2023-04-21 |
| Breast Pump Kit | OHH | Class 2 | Obstetrics/Gynecology | No | 2024-09-24 |
| Custom Anesthesia Tray | OGD | Class 2 | Anesthesiology | No | 2016-06-22 |
| Cesarean Section Tray | OHM | Class 2 | Obstetrics/Gynecology | No | 2025-09-30 |
| Tracheotomy Care Kit | NXA | Class 2 | Anesthesiology | No | 2015-08-14 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2016-08-23 |
| Tracheostomy Kit | OGW | Class 2 | Anesthesiology | No | 2015-08-14 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2015-08-17 |
| Pelvic Exam Kit | MLT | Class 2 | Obstetrics/Gynecology | No | 2015-08-14 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2016-08-18 |
| Umbilical Catheter Insertion Tray | PXJ | Class 2 | General Hospital | No | 2024-09-24 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2024-07-22 |
| Dialysis Administration Kit | PEV | Class 2 | Gastroenterology, Urology | No | 2017-06-30 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2017-05-24 |
| Endoscope Introducer Kit | NWU | Class 2 | Gastroenterology, Urology | No | 2015-08-14 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2015-08-14 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2015-08-17 |
| Bone Marrow Collection/Transfusion Kit | LWE | Class 2 | Unknown | No | 2015-08-14 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2015-08-17 |
| Arthrogram Tray | OII | Class 2 | Radiology | No | 2024-09-03 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2015-08-14 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2016-08-18 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2016-08-23 |
| Container, Specimen Mailer And Storage, Sterile | KDT | Class 1 | Pathology | No | 2016-03-10 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | Class 2 | Gastroenterology, Urology | No | 2016-08-03 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2015-11-24 |
| Blood And Urine Collection Kit (Excludes Hiv Testing) | OIB | Class 1 | Pathology | No | 2024-09-24 |
| Suture Kit | OVN | Class 2 | General, Plastic Surgery | No | 2015-08-14 |
| I.V. Start Kit | LRS | Class 2 | General Hospital | No | 2015-08-14 |
| Endoscopic Cholangiogram Kit | NWT | Class 2 | Gastroenterology, Urology | No | 2024-09-24 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2016-11-09 |
| Circumcision Tray | OHG | Class 2 | Obstetrics/Gynecology | No | 2015-08-14 |
| Cardiovascular Surgical Instruments Tray | OFA | Class 1 | Cardiovascular | No | 2015-08-14 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2015-08-17 |
| Laryngoscope Kit | OGH | Class 1 | Anesthesiology | No | 2024-09-24 |
| Pen, Marking, Surgical | HRP | Class 1 | Ophthalmic | No | 2015-08-14 |
| Bladder Irrigation Kit | PPA | Class 2 | Gastroenterology, Urology | No | 2018-07-19 |
| Tray, Biopsy, Without Biopsy Instruments | FCH | Class 1 | Gastroenterology, Urology | No | 2024-09-24 |
| Patient Personal Hygiene Kit | NSB | Class 1 | Dental | No | 2015-10-27 |
| Cardiovascular Procedure Kit | OEZ | Class 2 | Cardiovascular | No | 2016-03-17 |
| Sampler, Amniotic Fluid (Amniocentesis Tray) | HIO | Class 1 | Obstetrics/Gynecology | No | 2015-11-24 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2017-03-02 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2015-08-14 |
| Radiology-Diagnostic Kit | OIP | Class 2 | Radiology | No | 2016-06-10 |
| Dressing Change Tray | OXQ | Class 1 | General Hospital | No | 2015-08-14 |
| Eye Tray | OJK | Class 2 | Ophthalmic | No | 2015-08-14 |
| Media, Coupling, Ultrasound | MUI | Class 2 | Radiology | No | 2016-03-30 |
| Pap Smear Kit | OHL | Class 2 | Obstetrics/Gynecology | No | 2017-08-08 |
| Laparoscopic Gastrostomy Kit | PSD | Class 2 | Gastroenterology, Urology | No | 2025-06-18 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2020-06-23 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2016-03-11 |
| Clamp, Umbilical | HFW | Class 2 | Obstetrics/Gynecology | No | 2016-08-18 |
| Myringotomy Procedure Kit | OGS | Class 2 | Ear, Nose, Throat | No | 2018-09-24 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2015-08-14 |
| Phlebotomy Blood Collection Kit | OFM | Class 2 | Cardiovascular | No | 2015-08-14 |
| Counter, Sponge, Surgical | LWH | Class 1 | General Hospital | No | 2015-08-14 |
| Ct Biopsy Tray | OFG | Class 2 | Cardiovascular | No | 2024-09-24 |
| Obstetrical Kit | OKV | Class 2 | Obstetrics/Gynecology | No | 2015-08-20 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2017-07-14 |
| Suture Removal Kit | MCZ | Class 1 | General, Plastic Surgery | No | 2015-08-14 |
Proprietary Names
Hysterectomy kit
Anesthesia Conduction Kit
Plastic Surgery and Accessories Kit
NICU Oral Care Kit
Oral Care Kit
General Purpose Dental Tray
Spinal Epidural Anesthesia Kit
Epidural Kit
Wound Dressing Kit
Decubitus Treatment Kit
Tubing
Surgical Procedure Clamp
Towel Clamp
OJV / Single use instrument tray
Instrument Tray
Foam Instrument Pouch
Needle Counter/Holder
Catheter Care Tray
Universal Precautions Kit
Maximum Barrier Kit
Body Fluid Barrier Kit
Barrier Kit
Sterile Bowl
Basin Kit
CENTRAL LINE DRESSING CHANGE KIT
VAD DRESSING CHANGE KIT
PICC DRESSING CHANGE KIT
CVC DRESSING CHANGE KIT
OR Towel
Surgical Drape
Magnetic Instrument Drape
CARDIOVASCULAR
Port introducer kit
Burn kit without Drug
Forcep
Neurological Tray
Lambswool
Specialist Padding
Skin Protector
Adhesive Felt
Moleskin
Needle, Spinal
SurgiTrack
Instrument Tray Liner
Surgical Tray
Irrigation Syringe
Catheter Introducer Kit
Body Fluid Clean Up Kit
Spill Kit
Biohazard Spill Kit
CLAMP, CIRCUMCISION
Shears
Endoscope cleaning kit
Orthopedic Kit
Tube Gauze
Bandage Roll Gauze
External Gauze Sponge
Fluff Gauze
Gauze
Anesthesia kit
Central Venous Catheter Tray
Bandage Gauze Roll
Elastic Bandage
Disposable Instrument Kit
D and C tray
Cardiac Catheterization Kit
Urine Collection Kit (excludes HIV testing)
Gynecological Laparoscopic Kit
Skin Prep Tray
Chemo Spill Kit
Decontamination Kit
Clean- up Kit
Cyta Kit
Ear, nose, and throat surgical tray
Hemodialysis Kit
Dialysis Administration Kit (Start/Stop)
Dialysis Kit
TRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS
Electrode Kit
Alarm Kit
Tourniquet
Epidural anesthesia kit
Gown Tray
Labor and Delivery Kit
L&D Kit
Extension Set
Stockinette
Single Use Surgical Instruments: Staple Remover, Scalpel, Forceps, Scissor, Needle Holder, Hemostat
Disposable Instrument
Cautery Tip Cleaner
Drape
RSV Kit
ENT Surgery Kit
CONTAINER, SPECIMEN, NON-STERILE
Blood Culture Kit
Blood Specimen Collection Kit (excludes HIV testing)
Venipuncture Kit
Lab Draw Kit
Blood Specimen Collection Kit
EXT Set
Universal Block Kit
Nerve Block Tray
Neurology Procedure Tray
Pain Kit
Port Access Kit
Peripheral Catheter Insertion Kit
PICC Kit
Quick Kit
VAD Access Kit
Chemo Spill
Breast pump kit
Custom Anesthesia Tray
Cesarean section tray
Trach Care Kit
Tracheostomy Care Kit
Needle
ER Trach Kit
Tracheostomy Kit
Trach Kit
Endoscope Accessory and Cleaning Kit
Endo Transport Pad
Endoscope Brushes and Cleaning Accessories
Pelvic Exam Kit
Guide Wire
Umbilical catheter insertion tray
Retractor, Self-Retaining
Dialysis Administration Kit
Stocking
Endoscope Introducer Kit
Endoscopy Kit
General Surgery Tray (Kit)
Hip Pack
Hand Pack
Knee Pack
Toe Nail Kit
General Convenience Kit
General Purpose Kit
Gown Pack
Bone Marrow Collection Kit
Measuring Tape
Lesion Measure
Arthrogram tray
Lap Sponge
Internal X-Ray Gauze
Endoscopic Sponge
Specialty Sponge
Vaginal Sponge
Feeding Tube
Sterile Specimen Container
Urinary Cath Care Kit
Urinary Collection Kit for Foley
Anti Fog Solution
Blood and urine collection kit (excludes HIV testing)
Suture / Laceration Kit
Wound Closure Kit
ED/ER Suture Kit
IV Start Kit
GASTROENTEROLOGY-UROLOGY
Medical absorbent fiber
Circumcision Kit
Cardiovascular Surgical Instruments Tray
Chest Tube Kit
Tape
Laryngoscope kit
Surgeon's Marking Pen
Surgical Marking Pen
Bladder Irrigation Kit
TRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS
Patient Personal Hygiene Kit
Patient Admission Kit
ICU Hygiene Kit
Cardiovascular Procedure Kit
Amniocentesis Kit
IV set
Radiology Diagnostic Kit
Arthrogram Kit
Dressing Change Kit
Eye Kit
Ultrasound Lubricant / Gel
Pap Smear Kit
laparoscopic gastrostomy kit
Uterine Sound
Suture Bag
Sterile Cord Clamp
Myringotomy Procedure Kit
Surgical Light Shield
Light Shield Pack
Phlebotomy Blood Collection Kit
Surgical Sponge Counter
CT biopsy tray
Obstetrical Kit
Label
SUTURE REMOVAL KIT
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device