FDA Device Registration & Listing · BIRMINGHAM, GB · Registration 3013298431
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | Class 2 | 880.2800 | 2019-05-28 |
| PNR | Enteral Syringes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2023-03-17 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2019-04-25 |
| FMA | Depressor, Tongue, Non-Surgical | General Hospital | Class 1 | 880.6230 | 2023-03-14 |
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2022-11-09 |
| ELZ | Crown, Preformed | Dental | Class 1 | 872.3330 | 2019-01-14 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2019-05-20 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2019-05-20 |
| OHY | Pill Crusher/Cutter | General Hospital | Class 1 | 880.6430 | 2023-03-14 |
| LHI | Set, I.V. Fluid Transfer | General Hospital | Class 2 | 880.5440 | 2023-03-17 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2019-10-09 |
| ITG | Bandage, Cast | Physical Medicine | Class 1 | 890.3025 | 2023-02-10 |
| JOH | Tube Tracheostomy And Tube Cuff | Anesthesiology | Class 2 | 868.5800 | 2021-01-04 |
| LDE | Stethoscope, Manual | Cardiovascular | Class 1 | 870.1875 | 2020-10-21 |
| LWK | Razor, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-10 |
| MVL | Cord, Retraction | Unknown | Class U | N/A | 2019-04-25 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | Class 2 | 880.2800 | 2019-05-28 |
| HLI | Ophthalmoscope, Ac-Powered | Ophthalmic | Class 2 | 886.1570 | 2022-02-16 |
| HLJ | Ophthalmoscope, Battery-Powered | Ophthalmic | Class 2 | 886.1570 | 2022-02-16 |
| BYZ | Trap, Sterile Specimen | General Hospital | Class 2 | 880.6740 | 2023-05-01 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2023-01-05 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | Anesthesiology | Class 1 | 868.5240 | 2021-12-09 |
| HLS | Exophthalmometer | Ophthalmic | Class 1 | 886.1270 | 2020-10-21 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2023-06-21 |
| KOX | Solvent, Adhesive Tape | General, Plastic Surgery | Class 1 | 878.4730 | 2023-01-06 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2022-06-27 |
| DRX | Electrode, Electrocardiograph | Cardiovascular | Class 2 | 870.2360 | 2023-09-21 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2022-06-27 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2023-03-27 |
| DRX | Electrode, Electrocardiograph | Cardiovascular | Class 2 | 870.2360 | 2019-05-28 |
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-03-22 |
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | Class 2 | 862.1345 | 2019-03-06 |
| LFR | Glucose Dehydrogenase, Glucose | Clinical Chemistry | Class 2 | 862.1345 | 2019-03-06 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2023-07-11 |
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | Ophthalmic | Class 1 | 886.1860 | 2020-02-13 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2022-05-23 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2021-12-09 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2022-06-27 |
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | Class 1 | 890.5710 | 2022-06-29 |
| HEB | Tampon, Menstrual, Unscented | Obstetrics/Gynecology | Class 2 | 884.5470 | 2024-08-09 |
| FMH | Container, Specimen, Sterile | Pathology | Class 1 | 864.3250 | 2023-01-06 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4680 | 2022-11-07 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2025-02-20 |
| MDA | Elastomer, Silicone, For Scar Management | General, Plastic Surgery | Class 1 | 878.4025 | 2018-10-17 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2021-12-09 |
| GJS | Test, Time, Prothrombin | Hematology | Class 2 | 864.7750 | 2018-09-10 |
| KMF | Bandage, Liquid | General Hospital | Class 1 | 880.5090 | 2023-03-14 |
| JRS | Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) | Clinical Chemistry | Class 1 | 862.2050 | 2025-09-04 |
| HKM | Retinoscope, Battery-Powered | Ophthalmic | Class 1 | 886.1780 | 2020-10-21 |
| FXP | Cover, Shoe, Operating-Room | General, Plastic Surgery | Class 1 | 878.4040 | 2021-12-09 |
| FMW | Cover, Mattress (Medical Purposes) | General Hospital | Class 1 | 880.6190 | 2022-03-05 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | Class 2 | 870.2300 | 2021-01-11 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2022-06-28 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2023-03-13 |
| EZQ | Pouch, Colostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2024-03-11 |
| ETY | Tester, Auditory Impedance | Ear, Nose, Throat | Class 2 | 874.1090 | 2023-06-21 |
| KYW | Container, Liquid Medication, Graduated | General Hospital | Class 1 | 880.6430 | 2023-05-26 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2023-01-06 |
| KKX | Drape, Surgical, Antimicrobial | General, Plastic Surgery | Class 2 | 878.4370 | 2021-12-09 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2021-12-09 |
| GXY | Electrode, Cutaneous | Neurology | Class 2 | 882.1320 | 2022-11-07 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2018-10-17 |
| BYG | Mask, Oxygen | Anesthesiology | Class 1 | 868.5580 | 2023-03-27 |
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2023-11-16 |
| EXE | Protector, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2018-12-04 |
| EYQ | Garment, Protective, For Incontinence | Gastroenterology, Urology | Class 1 | 876.5920 | 2022-06-27 |
| FER | Anoscope And Accessories | Gastroenterology, Urology | Class 2 | 876.1500 | 2023-06-21 |
| ILS | Adaptor, Hygiene | Physical Medicine | Class 1 | 890.5050 | 2022-06-29 |
| PNG | Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | Gastroenterology, Urology | Class 2 | 876.5630 | 2021-05-31 |
| KKX | Drape, Surgical, Antimicrobial | General, Plastic Surgery | Class 2 | 878.4370 | 2022-08-24 |
| FOD | Device, Occlusion, Umbilical | General Hospital | Class 1 | 880.5950 | 2023-03-14 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2023-05-27 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2023-06-21 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2023-07-11 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2023-07-11 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2023-03-13 |
| MMK | Container, Sharps | General Hospital | Class 2 | 880.5570 | 2023-03-13 |
| FCY | Bulb, Inflation, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2023-08-24 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2019-04-25 |
| FON | Bag, Drainage, With Adhesive, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2019-11-20 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2022-06-27 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2019-10-09 |
| FMR | Device, Transfer, Patient, Manual | General Hospital | Class 1 | 880.6785 | 2022-01-20 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | Unknown | Class U | N/A | 2023-05-01 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2019-05-20 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | General, Plastic Surgery | Class 1 | 878.4450 | 2023-02-10 |
| FOB | Bedpan | General Hospital | Class 1 | 880.6730 | 2023-03-17 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | Class 1 | 880.6025 | 2023-03-13 |
| KMF | Bandage, Liquid | General Hospital | Class 1 | 880.5090 | 2025-11-25 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2023-01-05 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2023-01-04 |
| FOX | Stand, Infusion | General Hospital | Class 1 | 880.6990 | 2022-06-27 |
| GXZ | Electrode, Needle | Neurology | Class 2 | 882.1350 | 2022-11-07 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2021-12-09 |
| BYX | Tubing, Pressure And Accessories | Anesthesiology | Class 1 | 868.5860 | 2023-02-10 |
| DXQ | Blood Pressure Cuff | Cardiovascular | Class 2 | 870.1120 | 2021-06-24 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-01-20 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2022-06-27 |
| NNI | Container, Specimen, Non-Sterile | Pathology | Class 1 | 864.3250 | 2022-11-09 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4680 | 2022-11-07 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2021-12-09 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2020-02-13 |
| BSJ | Mask, Gas, Anesthetic | Anesthesiology | Class 1 | 868.5550 | 2023-01-05 |
| BZA | Connector, Airway (Extension) | Anesthesiology | Class 1 | 868.5810 | 2023-02-10 |
| MMK | Container, Sharps | General Hospital | Class 2 | 880.5570 | 2023-01-06 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | Class 2 | 870.1130 | 2023-03-26 |
| LRO | General Surgery Tray | General, Plastic Surgery | Class 2 | 878.4370 | 2022-08-25 |
| KGZ | Accessories, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2023-03-13 |
| HMP | Pad, Eye | General, Plastic Surgery | Class 1 | 878.4440 | 2023-03-14 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | Anesthesiology | Class 2 | 868.5150 | 2019-12-09 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2019-05-20 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2023-02-11 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2023-02-11 |
| EFS | Unit, Oral Irrigation | Dental | Class 1 | 872.6510 | 2026-04-02 |
| JOH | Tube Tracheostomy And Tube Cuff | Anesthesiology | Class 2 | 868.5800 | 2021-01-04 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2023-02-11 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2023-02-11 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2023-01-05 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-08-16 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2022-08-16 |
| GBX | Catheter, Irrigation | General, Plastic Surgery | Class 1 | 878.4200 | 2023-01-04 |
| FYF | Cap, Surgical | General, Plastic Surgery | Class 1 | 878.4040 | 2023-01-05 |
| GAP | Suture, Nonabsorbable, Silk | General, Plastic Surgery | Class 2 | 878.5030 | 2018-12-12 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2018-12-12 |
| GAL | Suture, Absorbable, Natural | General, Plastic Surgery | Class 2 | 878.4830 | 2018-12-12 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | General, Plastic Surgery | Class 2 | 878.5020 | 2018-12-12 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2018-12-12 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | General, Plastic Surgery | Class 2 | 878.4495 | 2018-12-12 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2018-12-12 |
| PNG | Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling | Gastroenterology, Urology | Class 2 | 876.5630 | 2021-06-01 |
| BXW | Calibrator, Volume, Gas | Anesthesiology | Class 1 | 868.1870 | 2025-11-25 |
| ERA | Otoscope | Ear, Nose, Throat | Class 1 | 874.4770 | 2020-02-13 |
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2023-08-24 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | Anesthesiology | Class 2 | 868.5800 | 2019-12-11 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2023-05-01 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2024-01-31 |
| KMJ | Lubricant, Patient | General Hospital | Class 1 | 880.6375 | 2023-03-18 |
| KMF | Bandage, Liquid | General Hospital | Class 1 | 880.5090 | 2023-01-06 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | Physical Medicine | Class 2 | 890.1385 | 2022-11-07 |
| GXZ | Electrode, Needle | Neurology | Class 2 | 882.1350 | 2022-11-07 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2019-07-01 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2022-12-14 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | Class 1 | 878.4014 | 2022-03-30 |
| GXB | Esthesiometer | Neurology | Class 1 | 882.1500 | 2023-05-01 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2023-02-10 |
| PUI | Drape, Surgical, Exempt | General, Plastic Surgery | Class 2 | 878.4370 | 2023-01-04 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4290 | 2022-06-27 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2023-03-18 |
| MEG | Syringe, Antistick | General Hospital | Class 2 | 880.5860 | 2023-03-18 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2023-03-18 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Clinical Chemistry | Class 1 | 862.1645 | 2019-01-11 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | General, Plastic Surgery | Class 2 | 878.4850 | 2024-05-14 |
| BZG | Spirometer, Diagnostic | Anesthesiology | Class 2 | 868.1840 | 2023-06-21 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | General, Plastic Surgery | Class 2 | 878.4840 | 2018-12-14 |
| BSY | Catheters, Suction, Tracheobronchial | Anesthesiology | Class 1 | 868.6810 | 2023-03-14 |
| CCX | Support, Patient Position | Anesthesiology | Class 1 | 868.6820 | 2023-03-14 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Anesthesiology | Class 2 | 868.1400 | 2023-03-17 |
| LRO | General Surgery Tray | General, Plastic Surgery | Class 2 | 878.4370 | 2023-03-24 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2023-01-08 |
| OEA | Non-Surgical Gown | General, Plastic Surgery | Class 1 | 878.4040 | 2021-12-09 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2018-09-17 |
| BYY | Tube, Aspirating, Flexible, Connecting | General Hospital | Class 2 | 880.6740 | 2023-03-13 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2018-11-13 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2023-06-21 |
| KMK | Device, Intravascular Catheter Securement | General Hospital | Class 1 | 880.5210 | 2021-12-09 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2021-12-09 |
| KXG | Applicator, Absorbent Tipped, Sterile | General Hospital | Class 1 | 880.6025 | 2022-08-25 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2018-10-17 |
| HBA | Neurosurgical Paddie | Neurology | Class 2 | 882.4700 | 2023-01-05 |
| JOK | Scissors, Medical, Disposable | General Hospital | Class 1 | 880.6820 | 2023-03-18 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2022-01-20 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2024-05-01 |
| FRC | Indicator, Biological Sterilization Process | General Hospital | Class 2 | 880.2800 | 2019-04-09 |
| DRX | Electrode, Electrocardiograph | Cardiovascular | Class 2 | 870.2360 | 2026-04-13 |
| FMP | Protector, Skin Pressure | General Hospital | Class 1 | 880.6450 | 2018-10-17 |
| CBH | Device, Fixation, Tracheal Tube | Anesthesiology | Class 1 | 868.5770 | 2023-02-10 |
| JOH | Tube Tracheostomy And Tube Cuff | Anesthesiology | Class 2 | 868.5800 | 2022-12-27 |
| EZR | Cement, Stomal Appliance, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2023-06-21 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2023-09-26 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2023-03-18 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2023-03-18 |
| KPE | Container, I.V. | General Hospital | Class 2 | 880.5025 | 2023-06-21 |
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2023-02-10 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4680 | 2022-11-07 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4760 | 2022-11-07 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2021-12-09 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2019-07-01 |
| MHW | Dressing, Compression | General Hospital | Class 1 | 880.5075 | 2023-03-18 |
| DRX | Electrode, Electrocardiograph | Cardiovascular | Class 2 | 870.2360 | 2023-07-08 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2019-05-20 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2021-12-09 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K203410 | Shantou Wealy Medical Instrument Co.,Ltd | ENFit Disposable Enteral Syringe | 2021-06-28 |
| K831798 | I M, Inc. | DISPOSABLE SCALPELS | 1983-07-19 |
| K221518 | Np Medical | NP Medical nCompass Extension Set with Stabilizing Base | 2022-11-03 |
| K953474 | Medikmark, Inc. | IV START KIT | 1995-10-02 |
| K972493 | Nipro Medical Corp. | NIPRO DISPOSABLE SOLUTION INFUSION SET | 1997-09-18 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0027-2007 | N/A | 2 | 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant. |
| Z-0013-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Z-0014-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Z-0015-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Z-0016-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3007412809 | STERIS Corporation | FRANKLIN PARK, IL, US |
| 2410251 | PROPPER MFG. CO., INC. | Long Island City, NY, US |
| 3009968482 | HU-FRIEDY MFG CO., LLC | Des Plaines, IL, US |
| 1417592 | MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, US |
| 3038191347 | ANQING CLEAN DENTAL INSTRUMENT TECHNOLOGY CO.,LTD | Anqing City Anhui, CN |
3013298431 when referencing this establishment in official correspondence.