meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
44
Latest Decision
1979-07-03

Clearances · page 153 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K790658 AIRCRAFT TRANSIT ISOLATOR MODEL 121 Vickers America Medical Corp. LGN Class II 1979-07-03
K790914 SILASTIC INTRAVENOUS CATHETER UNIT Dow Corning Corp. Healthcare Industries Materials FOZ Class II 1979-07-03
K790953 BORDISPO BRAND HYPODERMIC NEEDLE Borda Products, Inc. FMI Class II 1979-06-27
K790890 TEMPO2-I DISPOSABLE THERMOMETERS Airlife, Inc. FQZ Class I 1979-06-27
K790814 DELTA PUMP Spiess Design, Inc. FRN Class II 1979-06-27
K790901 I.V. TUBING ORGANIZER Acumed Instruments Corp. FPA Class II 1979-06-27
K791016 ULTICARE 2500 TREATMENT CHAIR American Health Care Industries, Inc. FRK Class I 1979-06-27
K790891 TEMPO2-II DISPOSABLE THERMOMETERS Airlife, Inc. FLK Class II 1979-06-27
K790967 CATHETER METAL HUB/RADIOPAQUE Jelco Laboratories FOZ Class II 1979-06-27
K791001 PENLIGHT/SWAB HOLDER Concept, Inc. KYT Class I 1979-06-22
K790954 HEEL GARD Fem-Gard, Inc. FRK Class I 1979-06-20
K790955 COVER GARD Fem-Gard, Inc. FRK Class I 1979-06-20
K772011 WHOLEY OCCLUSION BALLOON CATHETER Cook, Inc. FOZ Class II 1979-06-15
K790995 CONTEX Foam Tek, Inc. FMP Class I 1979-06-11
K790504 SANDEE SANDING BLOCK Dr. Bertram L. Steel LDQ 1979-06-11
K790968 CATHETER METAL HUB/NONRADIOPAQUE Jelco Laboratories FOZ Class II 1979-06-11
K790411 AUTO TRAUMA KIT Marshall Electronics, Inc. KME Class I 1979-06-01
K790699 TECNOL BODY HOLDER Tecnol New Jersey Wound Care, Inc. FMQ Class I 1979-06-01
K790559 ALARM Maddak, Inc. FRN Class II 1979-06-01
K790945 MODEL 113 TREONIC IP3 DIGITAL SYRINGE PU Vickers America Medical Corp. FRN Class II 1979-06-01
K782113 CAP, TAMPER PROOF PLASTIC Acacia, Inc. KPE Class II 1979-06-01
K790879 ULTIPOR SOLUTION CONTAINER FILTER Pall Biomedical Products Co. FPB Class II 1979-06-01
K790689 REVISED BATTERY CHARGER Vickers America Medical Corp. FPL Class II 1979-05-29
K790532 FEVER TESTER Maddak, Inc. KPD Class II 1979-05-29
K790582 INTRAVASCULAR ADMINISTRATION SET Y FPA Class II 1979-05-29
K790085 KAGER TRAPDUST Kager Intl. LDQ 1979-05-29
K790315 BLOOD CELL SEPARATOR SYSTEM CS3000 Travenol Laboratories, S.A. FRN Class II 1979-05-15
K790104 PISTORMATIC Zelby, Burstein, Hartman & Burstein KZH Class II 1979-05-14
K790669 DROP CONTROLLER Imed Corp. FLN Class II 1979-05-14
K782008 DRESSING, ENVIRON WOUND Abbott Laboratories KMF Class I 1979-05-14
K790677 EO EVACUATING SYSTEM I Castle Co. FLI Class II 1979-05-07
K790604 CUSTOM TUBING SETS Norton Performance Plastics Corp. FPA Class II 1979-05-04
K790659 INFANT SCALE DISPOSABLE LINER Hydro-Med Products, Inc. KME Class I 1979-04-30
K790408 T-CONNECTOR Medex, Inc. FPA Class II 1979-04-30
K790471 JELCO* DISC FILTER-0.2 MICRON Jelco Laboratories FPB Class II 1979-04-30
K790574 EPIC D215 National Patent Development Corp. FPA Class II 1979-04-30
K790424 FLU-VEN 01510 Venospital, Inc. FPA Class II 1979-04-30
K790077 BIOSTIL # 3884 Venospital, Inc. FPA Class II 1979-04-30
K790551 TRANSPORT INCUBATOR Narco Air-Shields FPL Class II 1979-04-24
K790409 LOW DEAD SPACE INSULIN SYRINGE Pharmaseal Div., Baxter Healthcare Corp. FMF Class II 1979-04-24
K790420 SUCTION CONNECTING TUBING Snyder Laboratories, Inc. BYY Class II 1979-04-23
K790419 YANKAUER & POODLE SUCTION INSTRUMENTS Snyder Laboratories, Inc. BYY Class II 1979-04-23
K790661 PROTECTOR II Richard-Allan Medical Ind., Inc. MMK Class II 1979-04-12
K790332 MODEL IV6000 INFUSION PUMP Valleylab, Inc. FRN Class II 1979-04-10
K790384 KIMLON BEDGARD UNDERPAD Kimberly-Clark Corp. KMF Class I 1979-04-10
K790416 DIATEK 500 Diatek, Inc. FLL Class II 1979-04-10
K790379 SEP-T-VAC SUCTION CANNISTER W/ TUBING Sherwood Medical Co. KDQ Class II 1979-04-10
K790373 IVAC 630 VOLUMETRIC INFUSION PUMP Y FRN Class II 1979-04-10
K790062 IV ADMINISTRATION SET WITH BACKCHECK National Patent Development Corp. FPA Class II 1979-04-10
K790283 PILLOW, CARTER ARM ELEVATION Depuy, Inc. KME Class I 1979-04-06
K790538 SPONGE COUNTER Devon Industries, Inc. LWH Class I 1979-04-04
K790547 PRO-TAB Professional Tape Co., Inc. KCT Class II 1979-04-03
K790405 ANCHOR BRAND COUNT-TAINER Anchor Products Co. MMK Class II 1979-03-26
K790035 AMBU SUCTION BOOSTER Narco Air-Shields CBC Class II 1979-03-23
K790358 FLUID ADMINISTRATION CAT.#14-923 Norton Performance Plastics Corp. GAZ Class II 1979-03-21
K790108 FILTERSET 0.22, I.V. PUMP Imed Corp. FPA Class II 1979-03-06
K790137 INFANT CARE SYSTEM Narco Air-Shields FMT Class II 1979-03-06
K790314 FLUID ADMINISTRATION SETS, 15 MICRON Medex, Inc. FPB Class II 1979-03-06
K782034 INFUSION PUMP, MODEL AS*5 Baxter Healthcare Corp FRN Class II 1979-02-27
K790210 STOCKINETTE, TUBULAR UNBLEACHED The Owenby Co. FQM Class I 1979-02-27
K790049 BED, PARAPLEGIC Wayne V. Kirkman FNL Class II 1979-02-27
K790140 SKIN CLOSURE TAPES STERILE Shur Medical Corp. FPX Class I 1979-02-27
K781815 HEMO-NATE SYRINGE BLOOD FILTER Gisco Intl. FPB Class II 1979-02-27
K790172 BK-5098 TILT TABLE STRAP Fred Sammons, Inc. FMQ Class I 1979-02-27
K790209 FILTER SYSTEM, ALTNER DISPOSABLE Orthopedic Equipment Co., Inc. GAZ Class II 1979-02-26
K782168 3-WAY STOPCOCK Medex, Inc. FMG Class II 1979-02-22
K790055 TUBING, DYNACOR UNIVERSAL Medline Industries, Inc. GCX Class II 1979-02-22
K782167 DELTA FLOW Medex, Inc. FMG Class II 1979-02-21
K790086 NEEDLE, TRUCARE VACUTAINER Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 1979-02-08
K790130 SCALE, DIGITAL CHAIR Acme Medical Scale Co. FRI Class I 1979-02-01
K790087 LUBRICANT, OTRHO PERSONAL Ortho Pharmaceutical Corp. KMJ Class I 1979-02-01
K790010 MANIFOLD, DISPOSABLE 3 VALVE Cordis Corp. FMG Class II 1979-02-01
K781813 SOLUTION ADMINISTRATION, TIP PROTECTOR Travenol Laboratories, S.A. FPA Class II 1979-01-17
K782019 CUTTER 888-00 INFUSION PUMP Sigmamotor, Inc. FRN Class II 1979-01-17
K782003 BAND AID* ADHESIVE BANDAGES Johnson & Johnson Professionals, Inc. FPX Class I 1979-01-17
K782043 INDICATOR, BIPOLAR TEMPERATURE Micronex, Inc. FLL Class II 1979-01-17
K782020 INFUSION PUMP, MODEL 5000 Sigmamotor, Inc. FRN Class II 1979-01-17
K790039 COUNTER, DISPOSABLE SURGICAL NEEDLE Anago, Inc. MMK Class II 1979-01-17
K782134 FILTER FOR HYPERALIMENTATION SET Travenol Laboratories, S.A. FPA Class II 1979-01-17
K782144 DISPOSABLE SURGICAL INSTRUMENT TIP Anago, Inc. KCT Class II 1979-01-05
K782027 HYSTERECTOMY T DRAIN Davol, Inc. JOL Class II 1978-12-20
K781877 UNDERPADS, HIGH ABSORBANT POLYMER Bridgewater Mfg. Corp. KMF Class I 1978-12-15
K781978 PUNCTURE KIT, DISPOSALBE VEIN Arrow Intl., Inc. FMF Class II 1978-12-12
K781988 SUCTION APPARATUS, POWERED BY COMP. AIR Farley, W.T. GCX Class II 1978-12-12
K781637 MODEL IV 1500 STANDARD BURETTE Valleylab, Inc. FPA Class II 1978-12-12
K781785 I.V. SET WITH IN-LINE FILTER Cutler Laboratories, Inc. FPA Class II 1978-12-07
K781812 SOLUTION ADMINISTRATION, FLEX VALVE Travenol Laboratories, S.A. FPA Class II 1978-12-07
K782001 ROSEALAE Asmb KME Class I 1978-12-07
K781832 SCALE, ACME DIGITAL BEDSIDE Acme Medical Scale Co. FRW Class I 1978-12-07
K781952 PAPER TAPE, HYPO ALLERGENIC Johnson & Johnson Professionals, Inc. FPX Class I 1978-12-07
K781876 ISOLETTE INCUBATOR Air-Shields, Inc. FMZ Class II 1978-12-07
K781981 DECONTAMINATION ITEMS BAG Medicare Industries, Inc. FRG Class II 1978-12-07
K781931 TAPE, ELASTOPLAST ELASTIC TEAR Beiersdorf, Inc. FQM Class I 1978-12-07
K781744 IV SET WITH GRADUATED CHAMBER National Patent Development Corp. FPA Class II 1978-12-07
K781796 BEDDING, DISPOSABLE HOSPITAL Kimberly-Clark Corp. KME Class I 1978-12-07
K781980 RESPIRATORY THERAPY GAS POUCH Medicare Industries, Inc. FRG Class II 1978-12-07
K781820 GLOVES, VINYL EXAMINATION Phoenix Glove Co. FMC Class I 1978-12-07
K781800 GRIP, HOSPITAL UTILITY Baka Manufacturing Co., Inc. KMK Class I 1978-12-07
K781437 SURGICAL PREP RAZOR Warren J. Grosjean LDQ 1978-12-05
K781817 OVU-GUIDE Reproduction Research Laboratories FLK Class II 1978-12-04

15,723 clearances in the General Hospital panel. Data: openFDA.