Data / Medical devices / India / Heuer International (A division of GST Corporation Limited)
Heuer International (A division of GST Corporation Limited): FDA-registered device maker in NOIDA Uttar Pradesh, India, 1 510(k) clearance
Heuer International (A division of GST Corporation Limited) is registered with the FDA (registration 3005273623) in NOIDA Uttar Pradesh, India. It lists 226 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 30, 1984. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005273623
- Address
- 142 A/52, Noida Special Economic Zone, Noida Phase-2, NOIDA Uttar Pradesh, India, 201305
- Owner or operator
- GST CORPORATION LIMITED (9075660)
- Roles
- Foreign private label distributor, Manufacturer, Repackager or relabeler
- First device listed
- July 27, 2005
- Registered through
- 2026
- Brand names listed
- GSTC, Gold Cross, HEUER, Heuer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories To Examination Light | PEQ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Accessories, Catheter | KGZ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Accessories, Traction | ILZ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Airway, Nasopharyngeal | BTQ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Airway, Oropharyngeal, Anesthesiology | CAE | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Amniotome | HGE | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Analyzer, Chemistry, Centrifugal, For Clinical Use | JJG | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Apparatus, Traction, Non-Powered | HST | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Assembly, Tube Housing, X-Ray, Diagnostic | ITY | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bag, Ice | KYR | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bag, Reservoir | BTC | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bag, Urinary, Ileostomy | EXH | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bag, Urine Collecting, Ureterostomy | EXG | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Balance, Analytical | JQO | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Band Or Belt, Pelvic Support | ISR | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bandage, Cast | ITG | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bandage, Liquid, Skin Protectant | NEC | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Belt, Pelvic, Traction | HSQ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bender | HXW | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Binder, Elastic | KMO | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bottle, Blow | BYO | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bottle, Hot/Cold Water | FPF | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Brace, Drill | HXY | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure | PWA | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Broach | HTQ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Burr, Orthopedic | HTT | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Caliper | KTZ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cannula, Injection | FGY | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Balloon Type | GBA | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Cholangiography | GBZ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Infusion | JCY | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Multiple Lumen | GBP | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Nasal, Oxygen | BZB | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Nasopharyngeal | ENW | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Rectal For Continent Ileostomy | KPH | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Centrifuge, Microsedimentation | GHK | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Chart, Visual Acuity | HOX | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Chisel, Bone, Surgical | EML | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clamp | HXD | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clamp And Cutter, Umbilical | NBZ | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Cannula | FKC | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Umbilical | HFW | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clip, Nose | BXJ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Collector, Urine, Pediatric, For Indwelling Catheter | FFH | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Component, Cast | LGF | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Component, External, Limb, Ankle/Foot | ISH | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Component, Traction, Non-Invasive | KQZ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cover, Mattress (Medical Purposes) | FMW | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Coverslips, Microscope Slide | KES | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cpr Aid Device Without Feedback | PMK | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cream, Gloving, Surgeon'S | KGQ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cushion, Flotation | KIC | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Device, Fixation, Tracheal Tube | CBH | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Device, General Purpose, Microbiology, Diagnostic | LIB | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Device, Incontinence, Urosheath Type, Sterile | EXJ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Device, Rebreathing | BYW | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Disinfector, Medical Devices | MEC | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Douche Apparatus, Vaginal, Therapeutic | HED | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Enema Kit | FCE | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Extractor | HWB | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| File | HTP | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Finger Cot | LZB | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Fluorometer, For Clinical Use | KHO | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Biopsy, Gynecological | HFB | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gag, Mouth | KBN | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauge, Gas Pressure, Cylinder/Pipeline | BXH | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Guide, Drill, Ligament | LXI | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Head Halter, Traction | IRS | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Hemocytometer | GHO | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Holder, Film, X-Ray | EGZ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Impactor | HWA | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Cast Application/Removal, Manual | LGG | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Joint, Hip, External Brace | ITS | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Joint, Hip, External Limb Component | ISL | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Knife, Orthopedic | HTS | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Laryngoscope, Non-Rigid | CAL | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Laryngostroboscope | EQL | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Magnifier, Hand-Held, Low-Vision | HJF | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mask, Oxygen, Low Concentration, Venturi | BYF | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Micro Pipette | JRC | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Microscope, Fluorescence/U.V. | IBK | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Microscope, Operating, Non-Electric, Ophthalmic | HRB | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Microscope, Surgical, General & Plastic Surgery | FSO | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mirror, Headband, Ophthalmic | HKF | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Biopsy, Cardiovascular | DWO | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Catheter | GCB | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Cerclage, Gynecological | HDH | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Neurosurgical Suture | HAS | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Suturing, Disposable | GAB | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Suturing, Reusable | GDL | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Abdominal | KTD | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Foot Drop | OHI | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Limb, For Back Pain | PMV | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Lumbo-Sacral | IPY | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Rib Fracture, Soft | IPX | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Thoracic | IPT | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Truncal/Orthosis, Limb | MRI | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Otoscope | ERA | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Percussor | GWZ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Ph Meter | JQY | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pipette, Diluting | GGY | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Portable Liquid Oxygen Unit Stand | PCM | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Positioner, Socket | KIL | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Probe | HXB | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pump, Nebulizer, Electrically Powered | JPW | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pusher, Socket | HXO | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Reamer | HTO | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retractor | GAD | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retractor, Vaginal | HDL | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Saw, Manual And Accessories | GDR | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scale, Patient | FRW | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scalpel, One-Piece | GDX | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Medical, Disposable | JOK | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Orthopedic, Surgical | HRR | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Surgical Tissue, Dental | EGN | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Umbilical | HDJ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Slides, Microscope | KEW | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Speculum, Non-Illuminated | FXE | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Speculum, Rectal | FFQ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Speculum, Vaginal, Metal | HDF | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Speculum, Vaginal, Nonmetal | HIB | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Splint, Clavicle | IQJ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Splint, Traction | HSP | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Staple Driver | HXJ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stapler, Surgical | GAG | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stethoscope, Esophageal | BZW | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stethoscope, Fetal | HGN | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stirrup, External Brace Component | ITC | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stocking, Elastic | ILG | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stripper, Surgical | HRT | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Stylet, Tracheal Tube | BSR | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Support, Arm | IOY | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Support, Breathing Tube | JAY | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Support, Hernia | EXN | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Balloon Inflation, Exempt | PTM | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Ent | KCP | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| System, Abortion, Vacuum | HHI | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | EYZ | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | PYO | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Thermometer, Clinical Mercury | FLK | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tourniquet, Gastro-Urology | EYR | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tracheotome | LJW | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Trocar | DRC | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Trocar, Tracheal | KCI | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tubing, Noninvasive | GAZ | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Twister, Wire | HXS | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Unit, Suction Operatory | EBR | 1 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Wire, Guide, Catheter, Exempt | PTL | 2 | Foreign private label distributor, Manufacturer, Repackager or relabeler | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 30, 1984 | K840383 | MENSTRUAL ASPIRATION KIT | HHI | Substantially Equivalent | Intl. Medical Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Support, Arm
- All makers of Stethoscope, Fetal
- All makers of Syringe, Balloon Inflation, Exempt
- All makers of Component, Traction, Non-Invasive
- All makers of Unit, Suction Operatory
- All makers of Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Updated April 30, 1984. 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.