Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 41
- Latest Decision
- 1983-09-12
Clearances · page 143 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K832556 | NEONATAL LUMBAR PUNCTURE TRAY | American Pharmaseal Div. Ahsc | FMI | Class II | 1983-09-12 |
| K831534 | PUMPETTE AS8P-INFUSION PUMP | Travenol Laboratories, S.A. | FRN | Class II | 1983-09-12 |
| K832288 | HEMOGLOBINOMETER | Mallinckrodt Critical Care | KMG | Class II | 1983-09-01 |
| K832102 | STERILE DISPOSABLE NEEDLES | Lee Medical Intl., Inc. | FMI | Class II | 1983-09-01 |
| K832329 | STERILE IV SET 4 SIZES | Abco Dealers, Inc. | FPA | Class II | 1983-08-24 |
| K831733 | TEMPERATURE MODULE 242-100 | Kontron Instruments, Inc. | FLL | Class II | 1983-08-24 |
| K832398 | DYNACOR CONNECTING TUBING | Medline Industries, Inc. | BYY | Class II | 1983-08-24 |
| K831063 | BUTTON INFUSER | Markwell Medical Institute, Inc. | FMI | Class II | 1983-08-24 |
| K831845 | PER-Q-CATH TRAY | Gesco Intl., Inc. | LJS | Class II | 1983-08-24 |
| K831668 | CONTINU-FLO SOLUTION ADMINISTRATION | Travenol Laboratories, S.A. | FPB | Class II | 1983-08-16 |
| K832167 | CORPAK VTR 300 ENTERNAL PUMP | Corpak Co. | FRN | Class II | 1983-08-16 |
| K832135 | A.M.S. TEMP. SCAN 300 | Andon Medical Systems, Inc. | FLL | Class II | 1983-08-16 |
| K832166 | FLO-GARD 8500 MICROINFUSION PUMP | Travenol Laboratories, S.A. | FRN | Class II | 1983-08-16 |
| K830656 | AMBULATORY MARK III INFUSION DEVICE | Windsor Medical, Inc. | FRN | Class II | 1983-08-16 |
| K831897 | BETA I PROGRAMMABLE INFUSION PUMP | Orange Medical Instruments, Inc. | FRN | Class II | 1983-08-12 |
| K831761 | SIMPLICITY PLUS | Critikon Company, LLC | FRN | Class II | 1983-08-12 |
| K832123 | VENIPUNCTURE VALVE | Abbott Laboratories | FPA | Class II | 1983-08-12 |
| K831315 | TRILEX | Tri-Med, Inc. | FPB | Class II | 1983-08-12 |
| K832120 | PROMINJET PUMP | Abbott Laboratories | FRN | Class II | 1983-08-12 |
| K831116 | INVAC W/VARIOUS MODELS | Pmt | GCX | Class II | 1983-08-12 |
| K831350 | IVFLO-HP & IVFIL-HP FILTER | Tri-Med, Inc. | FPB | Class II | 1983-08-12 |
| K832008 | INFUTROL 7000 INFUSION PUMP | Valleylab, Inc. | FRN | Class II | 1983-08-12 |
| K832377 | BIOCUFF INFUSION BAG PRESSOR | Bio-Medical Instruments , Ltd. | KZD | Class I | 1983-08-12 |
| K832042 | LME TEMP. MONITOR | Litton Medical Electronics | FLL | Class II | 1983-08-12 |
| K831964 | CMS 2000 SERIES TPN KITS | Currie Medical Specialties, Inc. | FMC | Class I | 1983-08-11 |
| K830741 | PARAMETRIC STERILITY RELEASE OF AUTO | United Surgical Corp. | GAG | Class II | 1983-08-11 |
| K831935 | ENTERNAL PUMP & ADMIN. SET 430 | Imed Corp. | FRN | Class II | 1983-08-08 |
| K832027 | ARGYLE YANKAVER SUCTION TUBE W/CONTROL | Sherwood Medical Co. | JOL | Class II | 1983-08-08 |
| K832128 | SELF-SEAL STERILIZATION POUCHES | Medical Industries Packaging, Inc. | KCT | Class II | 1983-08-08 |
| K831821 | PNEUMATIC/ELECTRIC/HYDRAULIC BED | G.W. Healthcare, Inc. | FNL | Class II | 1983-08-08 |
| K830541 | INJECTION SEALING CAP 13791 | Quinton, Inc. | FOZ | Class II | 1983-08-08 |
| K830931 | PORTABLE AUTOCLAVES | Arnold & Sons | FLE | Class II | 1983-07-27 |
| K832254 | BAXA ADDISEAL | Baxa Corp., Sub. of Cook Group, Inc. | KPE | Class II | 1983-07-26 |
| K832247 | I.V. BAG ADDISEAL | Baxa Corp., Sub. of Cook Group, Inc. | KPE | Class II | 1983-07-26 |
| K831395 | AVL 0073 MICROSAMPLER | Avl Scientific Corp. | FMI | Class II | 1983-07-26 |
| K831920 | PLASTIC TUBING CONNECTORS | Polymer Technology Corp. | BYY | Class II | 1983-07-19 |
| K831939 | TALL FLOOR STAND TFS-01 | Sorensen Research | GCX | Class II | 1983-07-19 |
| K831799 | PLASTIC DISPOSABLE RAZOR | I M, Inc. | LDQ | 1983-07-18 | |
| K831731 | INFANT EVALUATION CARRIER | E.M. Adams | FPP | Class I | 1983-07-18 |
| K831610 | INTRADISCAL THERAPY NEEDLE | Bd Becton Dickinson Vacutainer Systems Preanalytic | FMI | Class II | 1983-07-12 |
| K831596 | DROP RATE COUNTER #340 | Imed Corp. | FLN | Class II | 1983-07-12 |
| K831564 | ORTHOPEDIC SURGICAL GLOVE | Ansell, Inc. | FMC | Class I | 1983-07-12 |
| K831765 | HERAPIN LOCK FLUSH SOLUTION USE KIT | Smith & Nephew, Mpl Division | FMI | Class II | 1983-07-12 |
| K831718 | ELECTRONIC CLINICAL THERMOMETER | Mitteloy | FLL | Class II | 1983-07-12 |
| K831505 | THORACIC GAUGE #TG-60 -VACUUM REGULATOR | Sorensen Research | KDP | Class II | 1983-07-12 |
| K831722 | AC-22 AUTOCLAVE TAPE | Armak Tape Division | JOJ | Class II | 1983-07-06 |
| K831258 | FLO-GARD 6100 VOLUMETRIC INFUSION PUMP | Travenol Laboratories, S.A. | FRN | Class II | 1983-06-30 |
| K830730 | PORT-A-CATH IMPLANTABLE CATH. SYS | Pharmacia, Inc. | LJT | Class II | 1983-06-30 |
| K830748 | RESUSCITAIRE | Vickers America Medical Corp. | FMT | Class II | 1983-06-22 |
| K830622 | ORTHO WRAP | Fast Wrap Co., Inc. | FQM | Class I | 1983-06-20 |
| K831067 | BREATHING ZONE | Upper Four, Inc. | FRF | Class II | 1983-06-16 |
| K831595 | CASTLE MODEL 3341 & 3441 & 4141 GAS AER | Castle Co. | FLI | Class II | 1983-06-15 |
| K830906 | PULSAMAT MODEL 1050 | Ferring Laboratories, Inc. | FRN | Class II | 1983-06-15 |
| K831588 | INSTRUMENT GUARD CAPSULE | Treace Medical, Inc. | KCT | Class II | 1983-06-15 |
| K831311 | SOLUTION ADMIN. SETS W/FLASHBALL | Travenol Laboratories, S.A. | FPA | Class II | 1983-06-08 |
| K831551 | COMPRESSOGRIP TUBULAR ELASTIC BANDAGE | Fred Sammons, Inc. | FQM | Class I | 1983-06-07 |
| K831203 | Y-TYPE BACKCHECK MICROBORE EXTEN. SET | Abbott Laboratories | FRN | Class II | 1983-06-03 |
| K831425 | MDT CHEMITEST SEE-THRU BAG | Kenpak Converters, Inc. | FRG | Class II | 1983-06-02 |
| K822824 | ADHESIVE TAPE/FIRST-BAND | Leonard Joseph Co. | KGX | Class I | 1983-06-02 |
| K831312 | LOPEZ-HORN CARRIER | Chiron Vision Corp. | KYP | Class I | 1983-05-25 |
| K830592 | DISPOS. TYPE T THERMOCOUPLE TEMP.PROBE | Electromedics, Inc. | FLL | Class II | 1983-05-18 |
| K831028 | TI-1000 TRANSPORT INCUBATOR | Narco Scientific | FPL | Class II | 1983-05-09 |
| K831259 | RESERVOIR 1.5CC #9210 W/25 GAUGE/NEEDLE | Cardiac Pacemakers, Inc. | FRN | Class II | 1983-05-09 |
| K831253 | LANCER HEMOGLOBIN ANALYZER REAGENTS | Sherwood Medical Co. | KMG | Class II | 1983-05-09 |
| K830182 | CUSTOM IV SET | Custom Medical, Inc. | FPA | Class II | 1983-05-09 |
| K831165 | DUSTCOVERS/STERILITY MAINTENANCE COVERS | Medical Industries Packaging, Inc. | KCT | Class II | 1983-05-03 |
| K830453 | IV ADMINISTRATION SETS - MVP INFUSION | Ziehm International, Inc. | FPA | Class II | 1983-04-30 |
| K830697 | VENES HIGH COMPRESSION MEDICAL STOCK- | Futuro Div. Jung Corp. | DWL | Class II | 1983-04-30 |
| K831150 | PANASONIC MODEL HV-5 | Panasonic Co. Div. Matsu Elec. Corp. America | FLL | Class II | 1983-04-28 |
| K823206 | MARTIN PELVIC LIFT | Martin Pelvic Lift Co. | FSA | Class I | 1983-04-28 |
| K831088 | MINI-VOL I.V. SET | Beech Medical, Inc. | FPA | Class II | 1983-04-28 |
| K831087 | MINI-VOL EXTENSION SET | Beech Medical, Inc. | FPA | Class II | 1983-04-28 |
| K831089 | INFUSION PUMP | Beech Medical, Inc. | FLL | Class II | 1983-04-28 |
| K830755 | I.V. SETS WALRUS BRAND VARIOUS CONFIGUR- | Medical Parameters, Inc. | FPA | Class II | 1983-04-28 |
| K830972 | I.V. CATHETER PLACEMENT UNIT POLYURETH | Critikon Company, LLC | FOZ | Class II | 1983-04-27 |
| K823926 | BED-CHECK: II-IFAC | Bed-Check Corp. | KMI | Class I | 1983-04-18 |
| K830836 | Q.C. TESTER | Alltek Filtration, Inc. | LHI | Class II | 1983-04-18 |
| K830868 | COMBISET OR INFUSION SET | Pan-Tek Intl., Inc. | FPA | Class II | 1983-04-14 |
| K830486 | INFUSION PUMP #AS*6H | Baxter Healthcare Corp | FRN | Class II | 1983-04-14 |
| K830809 | GRASE BY DYNAMICS MS 27 SYRINGE DRIVER | Intermedics, Inc. | FRN | Class II | 1983-04-14 |
| K830891 | SPECIALTY SET MODEL IV7A01 | Valleylab, Inc. | FPA | Class II | 1983-04-14 |
| K830452 | PCA PUMP | Abbott Laboratories | FRN | Class II | 1983-04-14 |
| K823899 | INFANT CARE SYSTEM | Narco Scientific | FMI | Class II | 1983-04-14 |
| K830942 | SUCTION CATHETERS | Medovations, Inc. | JOL | Class II | 1983-04-14 |
| K830969 | PERM. REPAIR KIT FOR LEONARD NORTON DUAL | Norton Performance Plastics Corp. | LJS | Class II | 1983-04-14 |
| K831062 | ISOLATION MASK I.C.S. | American Threshold Industries, Inc. | LGM | Class II | 1983-04-13 |
| K830936 | TREONIC IP5 | Vickers America Medical Corp. | FRN | Class II | 1983-04-12 |
| K830165 | BEAR JET 150 VENTILATOR | Bear Medical Systems, Inc. | FLI | Class II | 1983-04-12 |
| K830970 | DOUBLE LUMEN TRANSFER DEVICE | Codan Trading Co. | LHI | Class II | 1983-04-12 |
| K830961 | EASY BREATHER HEADER BAGS | Medical Industries Packaging, Inc. | KCT | Class II | 1983-04-12 |
| K830780 | KOALA C99 I.V. CONTROLLER | Chesebrough-Pond'S U.S.A. Co. | LDR | Class II | 1983-04-08 |
| K830705 | MINI LANCET-BLOOD LANCET | Pharmaquest Corp. | FMA | Class I | 1983-04-08 |
| K823521 | STERILE HD CVP TRAY | Bill Dude Hospital Disposables, Inc. | FMF | Class II | 1983-04-08 |
| K823537 | GLUCOSE REAGENT | Ac Biochemical Laboratories, Inc. | FMF | Class II | 1983-04-06 |
| K830901 | CONNECTOR 5 IN 1, T-CONNECTOR | Medical Specialists IN Packaging | GAZ | Class II | 1983-04-06 |
| K830530 | TEMP TRACE | Progress Mankind Technology | FLL | Class II | 1983-04-06 |
| K830819 | MODIFICATION ELECTRONIC CLINICAL THERMO- | Mon-A-Therm, Inc. | FLL | Class II | 1983-04-06 |
| K830839 | AMER. 400 SERIES TEMP. PROBES-RECTALL | American Pharmaseal Div. Ahsc | FLL | Class II | 1983-04-06 |
| K830353 | ESOPHAGEAL PROBE W/TEMP. INDICATOR | Science Development Corp. | FLL | Class II | 1983-04-06 |
| K830835 | STERILE 5 IN 1 CONNECTORS | Abco Dealers, Inc. | GAZ | Class II | 1983-04-06 |
15,723 clearances in the General Hospital panel. Data: openFDA.