meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
35
Latest Decision
1982-11-24

Clearances · page 145 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K823035 COMPUTER INTERFACE MODULE CIM Y FRN Class II 1982-11-24
K823255 NON-STERILE REUSABLE NEEDLES Vertex Medical Corp. FMI Class II 1982-11-22
K823223 VIEW-PACK & MULTI POUCH Sbw Medical Packaging, Inc. FRG Class II 1982-11-22
K823026 380 PIGGYBACK CONTROLLER Imed Corp. LDR Class II 1982-11-22
K823027 ACCUDOT 380 SECONDARY I.V. SET Imed Corp. FPA Class II 1982-11-22
K823066 DESERT INSYTE-A HYPERTHERMIA SENSOR ACC Parke-Davis Co. FLL Class II 1982-11-17
K823270 HEAVY-DUTY I.V. STAND E.F. Brewer Co. FOX Class I 1982-11-17
K823074 CHEMDI STEAM & GAS STERILIZATION INDICA American Sterilizer Co. JOJ Class II 1982-11-08
K823036 AUTOCLAVE TESTING ADHESIVE TAPE Industrias Tuk, S.A. DE C.V. JOJ Class II 1982-11-08
K823120 EXACTA & CONNECTA STOPCOCKS W/EXTENSION Pioneer Viggo, Inc. FMG Class II 1982-11-08
K823056 THE INGLEFIELD MAGIC RING The Inglefield Co. FMF Class II 1982-11-03
K822775 INFUS. SETS-9120-50 CM & 9121-100 CM,EXT Cardiac Pacemakers, Inc. FPA Class II 1982-11-03
K822774 9110 SYRINGE Cardiac Pacemakers, Inc. FMF Class II 1982-11-03
K822159 ANGIOUROGRAPHY KIT Mallinckrodt Critical Care FMF Class II 1982-11-03
K822989 HARVARD APPARATUS SINGLE SPEED SYRINGE C.R. Bard, Inc. FRN Class II 1982-11-03
K822776 TEFLON CANNULA Cardiac Pacemakers, Inc. FOZ Class II 1982-11-03
K823017 INTRAVENOUS CATHETER PLACEMENT UNIT & Access Devices, Inc. FOZ Class II 1982-11-01
K822831 RI 300 DIFFERENTIAL TEMPERATURE MONITOR Instrumentation Industries, Inc. FLL Class II 1982-10-28
K823037 PLEUR-EVAC A-4005 SYSTEM Howmedica Corp. GCX Class II 1982-10-28
K822931 SCR WRAP Fox Converting, Inc. FRG Class II 1982-10-26
K822928 DISPOSABLE MICRO-INFUSION SYSTEM Orange Medical Instruments, Inc. FMF Class II 1982-10-26
K822556 CRITICAL MEASUREMENT UNIT Bemis Health Care BYZ Class II 1982-10-18
K822185 LARYNGEAL SYRINGE Kelleher Corp. FMF Class II 1982-10-18
K822454 SYRINGE PUMP 209-100 Medix Corp. FRN Class II 1982-10-18
K822557 SPECIMEN ADAPTOR Bemis Health Care BYZ Class II 1982-10-18
K822656 C-200 INFANT INCUBATOR Narco Scientific FMZ Class II 1982-10-18
K822848 PRIMARY & SECONDARY I.V. TUBING SETS David Simmonds Co., Inc. FPA Class II 1982-10-15
K822836 MICROFLEX-VENOFLUX Exco, Inc. FPA Class II 1982-10-15
K822574 INNOMED PD-1 KIT Innomed Corp. LJL Class I 1982-10-13
K822423 BABY TEMP PACIFIER Trp Energy Sensors, Inc. FQZ Class I 1982-10-13
K822421 INNOCOMB LICE COMB Innovative Products, Inc. LJL Class I 1982-10-13
K822571 SYRINGE PUMP Hirata Sangyo Co. USA, Inc. FRN Class II 1982-10-08
K822407 BOSTON SCALP VEIN INFUSION SETS The Boston Medical Group FPA Class II 1982-09-30
K822408 BOSTON INFUSION SETS The Boston Medical Group FPA Class II 1982-09-30
K822406 BOSTON SOLUTION INFUSION SETS The Boston Medical Group FPA Class II 1982-09-30
K822761 DELIVERY TUBE SET #2226 Delta Medical Industries FRN Class II 1982-09-30
K822410 BOSTON BLOOD DONOR SETS The Boston Medical Group BRZ Class II 1982-09-30
K822409 BOSTON BLOOD TRANSFUSION SETS The Boston Medical Group BRZ Class II 1982-09-30
K822484 INFECTION CONTROL TOWEL American Threshold Industries, Inc. LDQ 1982-09-30
K822650 SUPER DONUT Alimed, Inc. KME Class I 1982-09-30
K822420 REPLAM HYDROXYAPATATITE Replam Corp. FMF Class II 1982-09-28
K822760 ARTERIAL LINE KIT Martell Medical Products, Inc. FMF Class II 1982-09-28
K820948 THREE SECOND THERMOMETER #TS-1000 Temp-Stik Corp. FLL Class II 1982-09-24
K822732 LINEGUARD CATHETER SHIELD MODEL 100 Ray-Marshall Laboratory KMK Class I 1982-09-24
K822502 DISPOSABLE THERMOMETERS Hudson Oxygen Therapy Sales Co. FLK Class II 1982-09-24
K822354 DISPOSABLE PLASTIC TRANSFUS./INFUS. ASSB Valleylab, Inc. FPA Class II 1982-09-22
K822435 MEDI-THERM SKIN THERMOMETER Everest Interscience, Inc. FLL Class II 1982-09-22
K822482 SURGILITE NON-WOVEN WRAP Surgilite Intl., Inc. FRG Class II 1982-09-21
K822533 SYRINGES(3-PARTS SINGLE USE) Impex Laboratories FMF Class II 1982-09-17
K822534 NEEDLES(HYPODERMIC) Impex Laboratories FMF Class II 1982-09-17
K822434 CREST PRESSURE INFUSOR Crest Medical Equipment KZD Class I 1982-09-17
K822532 SYRINGES(2-PARTS SINGLE USE) Impex Laboratories FMF Class II 1982-09-17
K821185 NEW SUPPORT SYS. FOR BEDRIDDEN PATIENTS Dase Co. FNL Class II 1982-09-14
K822603 PERMA-SET INFUSION SET Cosmetic Sciences, Inc. LDR Class II 1982-09-14
K822286 AUTOCUFF (PHOTOS ENCLOSED WITH 510K Partamed, Inc. KZD Class I 1982-08-27
K822446 AES STOCKINGS Rampon Products DWL Class II 1982-08-27
K822238 DISPOSABLE TAIYANG SYRINGE S.D. Sunnyland Enterprises, Inc. FMF Class II 1982-08-25
K822311 DISPOSABLE COLLECTION BOTTLE W/TUBING Ohio Medical Products GCX Class II 1982-08-20
K820811 PROXIMATE DISPOSABLE SKIN STAPLERS ETHICON, Inc. GAG Class II 1982-08-20
K822098 BT 794-BLOOD/FLUID WARMER Electromedics, Inc. LGZ Class II 1982-08-20
K822211 STERILE HD PAN SET Hospital Disposables, Inc. FRG Class II 1982-08-16
K821555 EXACON THERMOMETER SYSTEM 8000 Sat Export Engineering & Trading FLL Class II 1982-08-16
K821997 MEDI + BIO SAFE STEAM STERILIZ. INDICAT Arvey Corp. JOJ Class II 1982-08-16
K822083 U-100 INSULIN SYRINGE Terumo Medical Corp. FMF Class II 1982-08-16
K821556 EXACON TEMP. PROBES SYSTEM 8000-#TH-103 Sat Export Engineering & Trading FLL Class II 1982-08-16
K821823 I.V. SENTINEL The John Bunn Co. FLN Class II 1982-08-16
K822027 I.V. ADMINISTRATION SET Baker & Hostetler FPA Class II 1982-08-12
K821995 SOLUTION ADMINISTRATION SET (W/O NEEDLE) Bertex Laboratories, Inc. FPA Class II 1982-08-05
K822135 SECA DIGITAL BABY SCALE 727 Seca Corp. FRW Class I 1982-07-30
K821013 IVEX-HP PEDIATRIC EXTENSION SET-SL Abbott Laboratories FPB Class II 1982-07-30
K822143 TOMAC LUBRICATING JELLY American Medical Systems, Inc. KMJ Class I 1982-07-30
K821842 GAS STERILIZATION EQUIPMENT Getinge International, Inc. FLF Class II 1982-07-28
K821957 CATH-LOK Hpd Medical, Inc. KMK Class I 1982-07-28
K822029 MONOJET 520 20CC SYRINGES W/NEEDLES Sherwood Medical Co. FMF Class II 1982-07-28
K822005 SPECIMEN COLLECTORS Kelleher Corp. GCX Class II 1982-07-28
K821896 C-300 INFANT INCUBATOR Narco Scientific FMZ Class II 1982-07-28
K821671 DISPO. AES. Hiraoka New York, Inc. FMF Class II 1982-07-28
K822023 DESERET SUBCLAVIAN JUGULAR CATH. SET Warner-Lambert Co. FOZ Class II 1982-07-28
K822042 SECA LIGHT WEIGHT BABY SCALE 744 Seca Corp. FRW Class I 1982-07-28
K821886 DESERET INSYTE HYPERTHERMIA CATHETER Warner-Lambert Co. FLL Class II 1982-07-28
K822043 SECA CHAIR SCALE-721 Seca Corp. FRW Class I 1982-07-28
K822024 BACILLU S SUBTILIS BIOLOGICAL INDICA. Findley Research, Inc. FRC Class II 1982-07-22
K821579 SKIN SCRUB-TRAY Associated Medical Products Co. LDR Class II 1982-07-21
K821833 HI-LO TEMP SKIN TEMPERATURE SENSOR Mallinckrodt Critical Care FLL Class II 1982-07-20
K821070 BIOMEDICAL FLUOROPTIC Luxtron FLL Class II 1982-07-13
K821929 SUBCLAVIAN Dna Medical, Inc. FOZ Class II 1982-07-08
K821750 DESERET E-Z SET INFUSION SET Warner-Lambert Co. FPA Class II 1982-07-02
K821835 BARRIER BURN SHEET Uhi Corp. KME Class I 1982-07-02
K821679 LEONARD/NORTON HYPERALIMENTATION CATHET. Norton Performance Plastics Corp. FOZ Class II 1982-07-02
K821841 MEDIGAS SUCTION/DRAINAGE EQUIPMENT Linde Div. Union Carbide Corp. GCX Class II 1982-07-02
K821377 AS 700 SERIES INFUSION PUMP ADMIN. Narco Scientific FPA Class II 1982-07-02
K821764 DISPOSABLE INTRAVENOUS INJECTION SYSTEM Medical Systems Research FPA Class II 1982-06-29
K821699 DESERET SUBCLAVIAN JUGULAR CATHETER SET Warner-Lambert Co. FOZ Class II 1982-06-24
K821796 EZ-FIX I.V. CATHETER HOLDER Dyna Care KMK Class I 1982-06-24
K821259 VITASAN Selomas, Inc. FQL Class I 1982-06-23
K821763 SHUR-STRIP APPLICATOR Shur Medical Corp. FPX Class I 1982-06-23
K821044 PATIENT PREP KITS/TRAYS-STERILE Phoenix Glove Co. FRG Class II 1982-06-23
K821260 VITOFIT Selomas, Inc. FQL Class I 1982-06-23
K821504 THERMAL WELL TEMPERATURE SENSOR Mon-A-Therm, Inc. FLL Class II 1982-06-23
K821773 PEDICRAFT BED, MODEL B2944 Pedicraft, Inc. FMS Class II 1982-06-23

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