Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 42
- Latest Decision
- 1978-02-28
Clearances · page 155 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K780230 | BED BOARD | Biomet, Inc. | FPS | Class I | 1978-02-28 |
| K780232 | RESTRAINT, PROTECTIVE | Biomet, Inc. | FMQ | Class I | 1978-02-21 |
| K780105 | NEEDLE CONNECTING SET, BLUNT | Abbott Laboratories | FOZ | Class II | 1978-02-21 |
| K780231 | BANDAGE, ELASTIC | Biomet, Inc. | FQM | Class I | 1978-02-21 |
| K780034 | AUTOCLAVE POUCHES&ROLLS/STEAM&GAS | E.M. Adams | FRG | Class II | 1978-02-21 |
| K780181 | GLOVES, FLOOR | Tillotson Rubber Co., Inc. | FML | Class I | 1978-02-21 |
| K780033 | MATTRESSES, CONDUCTIVE & COVERS | Chase Mfg. Co. | FMW | Class I | 1978-02-21 |
| K772403 | CUT-DOWN BUILT-UP TOILET SEAT | Fred Sammons, Inc. | LDQ | 1978-02-21 | |
| K780130 | BURETTE INTRAVENOUS ADMIN. SETS. | Y | FPA | Class II | 1978-02-21 |
| K780106 | PARENTERAL INFUSION CONTROLLER, ELEC. | National Patent Development Corp. | FLN | Class II | 1978-02-21 |
| K780171 | ELBOW PROTECTOR | Stat Medical Corp. | FMP | Class I | 1978-02-06 |
| K780145 | BLOOD FILTER, MICROEMBOLI-ATS-F10 | Sorensen Research | CAK | Class II | 1978-02-02 |
| K772354 | I.V. CATHETER | Ndm Corp. | FOZ | Class II | 1978-01-31 |
| K780086 | INFUSION APPARATUS, POWERED | Ohio Medical Products | FRN | Class II | 1978-01-30 |
| K772358 | ETHYLENE OXIDE STERILI. INDICATOR | Bio-Medical Sciences, Inc. | JOJ | Class II | 1978-01-30 |
| K772262 | TRAPEZE BAR KNOCKED DOWN | Med Fusion Systems, Inc. | FNJ | Class I | 1978-01-26 |
| K772336 | GLOVE & LATEX FINGER COTS | Jamar Health Products | FMC | Class I | 1978-01-26 |
| K772365 | THERMOMETER SHEATHS | Medline Industries, Inc. | FLK | Class II | 1978-01-26 |
| K772261 | TRAPEZE FLOOR BASE | Med Fusion Systems, Inc. | FNJ | Class I | 1978-01-26 |
| K772312 | FILTERSET W/Y-INJECTION SITE, 0.2 | Abbott Laboratories | FPB | Class II | 1978-01-26 |
| K772338 | SYRINGE, BLOOD, SAMPLING, ARTERIAL | C.R. Bard, Inc. | FMF | Class II | 1978-01-26 |
| K772419 | HEEL OR ELBOW PROTECTOR | Fred Sammons, Inc. | FMP | Class I | 1978-01-26 |
| K772260 | TELESCOPING BEDRAILS | Med Fusion Systems, Inc. | FNJ | Class I | 1978-01-26 |
| K771983 | SCALP VEIN SET | Berman, Pcp & Consultants, Inc. | FPA | Class II | 1978-01-05 |
| K772008 | SCALP VEIN SETS | Suru Chemicals & Pharmaceuticals, Ltd. | FPA | Class II | 1978-01-03 |
| K771972 | 5UM FILTERSET WITH Y-INJECTION SITE | Abbott Laboratories | FPB | Class II | 1978-01-03 |
| K772060 | PROTECT IV GARD | Omnicon Medical Corp. | FMP | Class I | 1977-12-20 |
| K772227 | CATH KIT, SUPERPUBIC | American Hospital Supply Corp. | KXF | Class I | 1977-12-20 |
| K771737 | SUCTION CANISTER | Bemis Health Care | GCX | Class II | 1977-12-20 |
| K772233 | THERMOMETER RECAL ADAPTER | Info-Chem | FQZ | Class I | 1977-12-20 |
| K772217 | TEMPERATURE MONITOR | Hudson Oxygen Therapy Sales Co. | FLL | Class II | 1977-12-13 |
| K771935 | DIGITAL THERMOMETER | Medical Networks | FLL | Class II | 1977-12-08 |
| K771300 | INTRAVENOUS INFUSION PUMP | Stewart-Naumann Laboratories | FRN | Class II | 1977-12-08 |
| K771911 | PLASTIC STOPCOCK W/ EXTENSION TUBE | Medon Corp. | FMG | Class II | 1977-12-08 |
| K772094 | LIFECARE I.V. PUMP - MODEL III | Abbott Laboratories | FRN | Class II | 1977-12-08 |
| K772129 | MEDI-JECTOR | Derata Corp. | KZE | Class II | 1977-12-08 |
| K772135 | BIOLOGICAL/CHEMICAL INDICATOR | Amsco Co. | JOJ | Class II | 1977-12-08 |
| K771022 | CATHETER, UMBILICAR ARTERY | Axiom Medical, Inc. | FOS | Class II | 1977-11-29 |
| K771996 | TELETHERMOMETER MODEL T T-100 | Electromedics, Inc. | FLL | Class II | 1977-11-22 |
| K771995 | ELECTROTHERM MODELS TC-100 & M-99 | Electromedics, Inc. | FLL | Class II | 1977-11-22 |
| K772036 | IN-LINE BURETTE SET | Abbott Laboratories | FPA | Class II | 1977-11-16 |
| K772062 | NEONATAL FLOTATION SYSTEM | Medpro, Inc. | IKY | Class I | 1977-11-15 |
| K771998 | TEMP-A-LERT MODEL TA-986 | Electromedics, Inc. | FLL | Class II | 1977-11-15 |
| K771913 | HEEL/ELBOW PROTECTOR | Alba-Waldensian, Inc. | FMP | Class I | 1977-11-15 |
| K771997 | TELETHERMOMETER MODEL T T-400 | Electromedics, Inc. | FLL | Class II | 1977-11-15 |
| K771619 | PROXIMATE DISP. SKIN STAPLER | ETHICON, Inc. | GAG | Class II | 1977-11-15 |
| K771999 | ELECTROTHERM MODELS F&C18,14,78, F84 | Electromedics, Inc. | FLL | Class II | 1977-11-15 |
| K772119 | TIME WATCH | Akzona, Inc. | FPK | Class II | 1977-11-14 |
| K772020 | CLOTH ADHESIVE TAPE | Johnson & Johnson Professionals, Inc. | FPX | Class I | 1977-11-02 |
| K771994 | ELECTROTHERM MODEL HT-1 | Electromedics, Inc. | FLL | Class II | 1977-11-02 |
| K771980 | FEVER TESTER | American Thermometer Company, Inc. | KPD | Class II | 1977-11-02 |
| K771891 | CATHETER, UMBILICAL, VICRA | Travenol Laboratories, S.A. | FOS | Class II | 1977-11-02 |
| K771124 | INSTRUMENT TRAY PAD | Devon Industries, Inc. | KCT | Class II | 1977-10-28 |
| K771123 | SURGICAL INSTRUMENT PROTECTOR | Devon Industries, Inc. | KCT | Class II | 1977-10-28 |
| K771536 | AIR VENT FILTER NEEDLE, 0.45 | Jelco Laboratories | FPB | Class II | 1977-10-25 |
| K771025 | PHOTOTHERAPY/PROCEDURE LAMP | Cavitron Corp. | LBI | Class II | 1977-10-25 |
| K771888 | SYRINGE, DISPOSABLE | Orthopedic Equipment Co., Inc. | FMF | Class II | 1977-10-21 |
| K771824 | MEDPRO FLOTATION SYSTEM | Medpro, Inc. | IKY | Class I | 1977-10-19 |
| K771177 | SURGICAL STAPLING INSTRU., AUTO, SUTURE | United States Surgical, A Division of Tyco Healthc | GAG | Class II | 1977-10-18 |
| K771667 | BLOOD GAS TRAY #4024 | Concord Laboratories, Inc. | FMI | Class II | 1977-10-13 |
| K771381 | IV CATHETER HUB | Jelco Laboratories | FOZ | Class II | 1977-10-13 |
| K771846 | SUOGIPEEL PACKAGING SYSTEM | Surgicot, Inc. | FRG | Class II | 1977-10-13 |
| K771862 | TRANSFUSION BLOOD FILTER | Medical, Inc. | FPB | Class II | 1977-10-13 |
| K771712 | CATHETER DRESSING CHANCE SET | Shield Laboratories, Inc. | FRL | Class I | 1977-10-13 |
| K771758 | ELASTOMULL GAUZE BANDAGE | Beiersdorf, Inc. | FQM | Class I | 1977-10-13 |
| K771826 | INTRAVENOUS FILTER W/AUTO AIR VENT | Jelco Laboratories | FPB | Class II | 1977-10-13 |
| K771757 | EXAM GLOVES | Jamar Health Products | FMC | Class I | 1977-10-13 |
| K771827 | INTRAVENOUS FILTER W/FLASH BULB | Jelco Laboratories | FPB | Class II | 1977-10-13 |
| K771158 | ID BRACLETS, ADULT & INFANT | Divers-A-Med | LDR | Class II | 1977-10-13 |
| K771539 | STEPPER | Tridak | KYX | Class I | 1977-10-07 |
| K771551 | I.V. PREP & CARE KIT | Jelco Laboratories | FRL | Class I | 1977-10-04 |
| K771791 | NEEDLE COUNTING | Chase Mfg. Co. | MMK | Class II | 1977-10-04 |
| K771630 | LIMB RESTRAINT | Medical Restraints, Inc. | FMQ | Class I | 1977-09-30 |
| K771636 | BODY RESTRAINT | Medical Restraints, Inc. | FMQ | Class I | 1977-09-30 |
| K771629 | HAND RESTRAINT | Medical Restraints, Inc. | FMQ | Class I | 1977-09-30 |
| K771659 | PATIENT RESTRAINT SYSTEM | Mtd, Inc. | FMQ | Class I | 1977-09-30 |
| K771673 | CATHETEO CARE TRAY #0242 | Concord Laboratories, Inc. | FMC | Class I | 1977-09-30 |
| K771113 | AUTO SUTURE R CLIP INSTRUMENT | United States Surgical, A Division of Tyco Healthc | GAG | Class II | 1977-09-30 |
| K771632 | FINGER MITT RESTRAINT | Medical Restraints, Inc. | FMQ | Class I | 1977-09-28 |
| K771634 | VEST RESTRAINT | Medical Restraints, Inc. | FMQ | Class I | 1977-09-28 |
| K771594 | PRIMARY PIGGYBACK VENOSET W/ FILTER | Abbott Laboratories | FPB | Class II | 1977-09-28 |
| K771679 | MICROFLATOR | Fisons Corp. | FLG | Class I | 1977-09-28 |
| K771738 | MALE URINAL | Bemis Health Care | FNP | Class I | 1977-09-28 |
| K771715 | PELVIC WHEELCHAIR RESTRAINT | Medical Restraints, Inc. | FMQ | Class I | 1977-09-28 |
| K771432 | HICALIQ IVH BAG | Terumo America, Inc. | KPE | Class II | 1977-09-28 |
| K771733 | 8 EMESIS BASIN | Bemis Health Care | FNY | Class I | 1977-09-28 |
| K771635 | FOOT ELEVATOR | Medical Restraints, Inc. | FMQ | Class I | 1977-09-28 |
| K771430 | BLOOD FILTER, W/SET | Terumo America, Inc. | FPB | Class II | 1977-09-20 |
| K771573 | DUO-CATH FEMORAL | Medical Device Laboratories | FOZ | Class II | 1977-09-15 |
| K771584 | ARTEOIAL BLOOD SAMPLING KIT 2D9014 | Travenol Laboratories, S.A. | FMF | Class II | 1977-09-13 |
| K771593 | I.V. PUMP SET FOR FAT EMULSION | Abbott Laboratories | FPA | Class II | 1977-09-12 |
| K771271 | SCALP VEIN SET | Berman, Pcp & Consultants, Inc. | FPA | Class II | 1977-09-12 |
| K771269 | BLOOD COLLECTION SET TYPE H | Berman, Pcp & Consultants, Inc. | FPK | Class II | 1977-09-12 |
| K771270 | BLOOD ADMINISTRATION TYPE R | Berman, Pcp & Consultants, Inc. | FPA | Class II | 1977-09-12 |
| K771267 | INFUSION SET TYPE S | Berman, Pcp & Consultants, Inc. | FPA | Class II | 1977-09-12 |
| K771272 | DISP. SYRINGES: 2,5 & L0 MI. | Berman, Pcp & Consultants, Inc. | FMF | Class II | 1977-09-12 |
| K771633 | HEEL PROTECTOR | Medical Restraints, Inc. | FMP | Class I | 1977-09-12 |
| K771664 | VOLUMETRIC INFUSION PUMP MODEL 960 | Imed Corp. | FRN | Class II | 1977-09-12 |
| K771563 | CONFORM ELASTIC NETTING | Kendall Research Center | FQM | Class I | 1977-09-12 |
| K771268 | INFUSION SET TYPE J | Berman, Pcp & Consultants, Inc. | FPA | Class II | 1977-09-12 |
15,723 clearances in the General Hospital panel. Data: openFDA.