meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
44
Latest Decision
1985-08-15

Clearances · page 136 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K850289 MONARCH STERILIZATION CONTAINER SYSTEM Monarch Products, Inc. FRG Class II 1985-08-15
K850395 THE FEVER-THERM A THERM. MEASURING DEVICE Kma, Inc. FLL Class II 1985-08-13
K853184 PIGGYMATE I.V. TUBING LOCK Trend Medical, Inc. FPA Class II 1985-08-13
K851660 DONWAY LIFTING FRAME Australian Biomedical Corporation , Ltd. FPP Class I 1985-08-07
K844649 ELECTRICALLY HEATED STERILIZER STEAM STERILIZER Takizawa Medical Instruments Manufacturer FLE Class II 1985-08-05
K852954 B-D DIGITAL FEVER THERMOMETER Bd Becton Dickinson Vacutainer Systems Preanalytic FLL Class II 1985-08-05
K852408 EXTRA LARGE ADHESIVE STRIPS American White Cross, Inc. KGX Class I 1985-07-29
K852818 STERILE DISPOSABLE SYRINGES(2 PIECES) Fabersanitas, S.A. FMF Class II 1985-07-29
K852989 WINGED INFUSION SETS An-Med Intl. FPA Class II 1985-07-26
K852937 THE IVY POLE-INTRAVENOUS BOT TREES #1121K & 1221K Northern Customfab, Inc. FOX Class I 1985-07-26
K852462 TRICOT ADHESIVE BANDAGE American White Cross, Inc. KGX Class I 1985-07-26
K852890 AM FAB SIDE RAILS MODEL 5000 Am Fab, Inc. FNJ Class I 1985-07-24
K852903 TOSHIBA DIGITAL CLINICAL THERMOMTER Toshiba Medical Systems FLL Class II 1985-07-24
K851523 DISPOSABLE PLASTIC SYRINGES Transcoject GmbH & Co. KG FMF Class II 1985-07-24
K852544 MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES Sherwood Medical Co. FMF Class II 1985-07-23
K852588 MONOJECT STERILE 6CC SYRINGE W/ & WO/ NEEDLES Sherwood Medical Co. FMF Class II 1985-07-23
K852580 MONOJECT STERILE 60CC SYRINGES Sherwood Medical Co. FMF Class II 1985-07-23
K852640 MONOJECT STERILE 35CC SYRINGES Sherwood Medical Co. FMF Class II 1985-07-23
K852607 MONJECT STERILE 20CC SYRINGES Sherwood Medical Co. FMF Class II 1985-07-23
K851103 VASCULAR IMPLANT ACCESS NEEDLE SET Baxter Healthcare Corp FMI Class II 1985-07-16
K852361 INTRAVENOUS INJECTION SET The West Co., Inc. FPA Class II 1985-07-16
K852674 STRYKER 988 ICU BED Stryker Corp. FNL Class II 1985-07-16
K851804 BIO-CHALLENGE TEST PAK Propper Mfg. Co., Inc. JOJ Class II 1985-07-16
K852375 I.V. STARTER TRAY W/DYNADERM TRANSPARENT ADHESIVE Ferris Mfg. Corp. LRS Class II 1985-07-11
K844244 DERATA MEDI-JECTOR PRO Derata Corp. KZE Class II 1985-07-05
K852358 SYRINGE INFUSION PUMP - AS 20 SERIES Baxter Healthcare Corp FRN Class II 1985-07-05
K851142 TELET-LEX MEDICAL IV CATHETER PLACEMENT Teleflexmedical, Inc. FOZ Class II 1985-07-05
K851464 PULSE MED CUSTOM PKG. PROC. TRAYS OPERATING ROOMS Pulse Med, Inc. FMF Class II 1985-07-05
K851821 VI-FLOW PUMP WITH VI-SET Vital Canada, Inc. FRN Class II 1985-07-05
K852422 MODEL 500 PEDIATRIC STRETCHER/CRIB Midmark Corp. FMS Class II 1985-07-05
K851358 MODEL BION 2/TYPE 90 ROOM IONIZER Medicor USA , Ltd. FRF Class II 1985-07-01
K852301 INOX THERMOMETER JAR Broadwest Corp. FLK Class II 1985-07-01
K851809 VACUUM COMPRESSION INJECTOR Uci Corp. KZE Class II 1985-07-01
K851370 INTERFACE TRANSFUSION BLOOD FILTER #35 Medical, Inc. CAK Class II 1985-06-27
K852087 CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORS Terumo Medical Corp. FLL Class II 1985-06-27
K852433 INFUSAFE 205 CATOLOG NO. 205.000 Medix Medical Electronics (U.S.A.), Inc. FLN Class II 1985-06-27
K852488 CONTROLLED RELEASE INFUSION SYSTEM(CRIS) Y FPA Class II 1985-06-27
K852300 INOX IV STAND Broadwest Corp. FOX Class I 1985-06-20
K851094 MODEL BION 1/TYPE 1084T CAR IONIZER Medicor USA , Ltd. FRF Class II 1985-06-19
K851981 NO. 5300-3 1/2 FRENCH UMBILICAL VESSEL CATH. ETC. Superior Plastic Products Corp. FOZ Class II 1985-06-18
K852173 MERIVAARA CRIB TROLLEY-MODEL 381 Daun International, Inc. FMS Class II 1985-06-17
K851979 TROCAR CATHETER Hospital Products Group JOL Class II 1985-06-17
K851519 FORTUNA DISPOSABLE SYRINGES Impor-Tex, Intl., Inc. FMF Class II 1985-06-17
K852041 DEKNATEL THORACIC CATHETER Pfizer, Inc. JOL Class II 1985-06-17
K850599 HOME BILI LIGHTS-MODEL 100 Physician Engineered Products, Inc. LBI Class II 1985-06-17
K850144 BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH American Sterilizer Co. FRC Class II 1985-06-17
K851892 COMPACT 2000 Atrium Medical Corp. KDQ Class II 1985-06-14
K852329 STAND, OPERATING ROOM Scholten Surgical Instruments, Inc. FOX Class I 1985-06-14
K851327 DESERET ARTERIAL CATHETER Parke-Davis Co. FOZ Class II 1985-06-14
K852246 YSI MODEL 791/799 DISP TEMP PROBE & 7900 EX CABLE Yellow Springs Instrument Co., Inc. FLL Class II 1985-06-10
K852106 I.V. ADMINISTRATION SET Mediflex Intl. FPA Class II 1985-06-07
K850035 EMPTY SOLUTION TRANSFER CONTAINER The Healthcare Group Laboratories, Inc. KPE Class II 1985-06-07
K852259 IVENT INTRAVENOUS ADMINSTRATION SET Ivent Corp. FPA Class II 1985-06-07
K851258 WECK LX TM SKIN STAPLER Edward Weck, Inc. GAG Class II 1985-06-07
K852060 INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123 Cardiac Pacemakers, Inc. FRN Class II 1985-06-07
K851918 INFANT PHOTOTHERAPY MASK Alba Health Care FOK Class I 1985-06-07
K852203 KIMGUARD PROCEDURE TRAY Kimberly-Clark Corp. FRG Class II 1985-06-07
K852078 SPECTRUM(TENTATIVE) Parke-Davis Co. FOZ Class II 1985-06-07
K852278 ACME(BRAND) LOW-PROFILE WHEELCHAIR SCALE, 17400 Acme Medical Scale Co. FRW Class I 1985-06-07
K851449 OHMEDA 5000 INFANT WARMER SYSTEM Ohmeda Medical FMT Class II 1985-06-07
K851195 VASCULAR ACCESS CATHETER Sil-Med Corp. LJS Class II 1985-06-07
K852073 VIAL SYRINGE PUMPS, SE200, SE200B & SE400 Hospal Medical Corp. FRN Class II 1985-06-07
K851407 SURGICAL TOWELS Diack JOJ Class II 1985-06-07
K851617 TODAY PERSONAL LUBRICANT Vli Corp. KMJ Class I 1985-06-06
K851181 PRECI-JET 50 Ulster Scientific, Inc. KZE Class II 1985-06-06
K851611 IMPACT TURBO CATH Impact Instrumentation, Inc. JOL Class II 1985-06-05
K850264 TUTTNAUER PRE-VACUUM AUTOCLAVE Tuttnauer Co. , Ltd. FLE Class II 1985-06-04
K852140 NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS) North American Instrument Corp. FPA Class II 1985-05-30
K850069 BORNING NEONATAL RESUSCITATOIN CENTER Borning Corp. FMT Class II 1985-05-30
K851564 MODEL 2000 INDULIN INFUSION PUMP Bd Becton Dickinson Vacutainer Systems Preanalytic FRN Class II 1985-05-30
K851351 ENTERAL FEEDING PUMP Empire Industries, Inc. FRN Class II 1985-05-30
K851336 IV/0165 INFUSION SET Infarkem Corp. FPA Class II 1985-05-30
K852030 PEDIATRIC IV WATCH Alltek, Inc. FPB Class II 1985-05-30
K852029 I.V. WATCH Alltek, Inc. FPB Class II 1985-05-30
K852035 HEALTH-O-METER PHYSICIANS, DIGITAL ELEC SCALES Continental Scale Corp. FRW Class I 1985-05-29
K850769 VIGGO ACCESSORIES FOR I.V. THERAPY Viggo Products FPA Class II 1985-05-29
K851390 STERILE GENERAL HOSPITAL SUPPLIES Biological & Environmental Control Laboratories LDQ 1985-05-29
K851146 DIGITAL THERMOMETER Micro Idea Instrument Co., Ltd. FLL Class II 1985-05-23
K851029 NEW VITAJET Andrew V. Stadler KZE Class II 1985-05-23
K851147 AUTORANGING DIGITAL CLINICAL THERMOMETER Micro Idea Instrument Co., Ltd. FLL Class II 1985-05-23
K851385 THORA-CATH TROCAR-TYPE CHEST DRAINAGE TUBE Gesco Intl., Inc. JOL Class II 1985-05-23
K850496 TRANSPORT INCUBATOR 185 Airborne Life Support Systems, Inc. FPL Class II 1985-05-23
K851986 STOPCOCKS Transamerica Delaval, Inc. FMG Class II 1985-05-23
K851005 XRO UMBILICAL CATHETER-CODE 270 Vygon Corp. FOS Class II 1985-05-21
K850419 AUTO TURNER George J. Kamilar FNM Class II 1985-05-21
K851844 MOLIFT Madshus A/S FSA Class I 1985-05-17
K844193 QUINTON INJECTION SEALING CAP Quinton, Inc. FOZ Class II 1985-05-17
K850967 STERILE CORMED MEDIPORT Cormed, Inc., Sub. C.R.Bard, Inc. LJT Class II 1985-05-17
K850424 MARC MEDICAL PROBE COVER-200 K&M Plastics FLL Class II 1985-05-15
K843435 LABMASTER & CRSI 600 Control Resource Systems, Inc. FRF Class II 1985-05-15
K851276 ACTION PAC South Mountain Medical LDQ 1985-05-15
K844578 NON-MAGNETIC EXAMINATION TABLE FOR MAGNETIC RESONA Engineering Dynamics Corp. FPO Class II 1985-05-14
K850997 UVP 2000 VOLUMED -TENTATIVE Sterling Medical Devices, Inc. FRN Class II 1985-05-13
K851873 FORTEC MI-305 Nam Tai , Ltd. FLL Class II 1985-05-13
K851742 MEDICAL EXAMINATION LIGHTS Burton Medical Products Corp. KZF Class I 1985-05-13
K851904 DATA TRAC ANESTHESIOLOGY RECORDER Datascope Corp. KZD Class I 1985-05-10
K850529 SHEER ADHESIVE BANDAGES, STERILE Abco Dealers, Inc. KGX Class I 1985-05-10
K851704 THERMOMED Draeger Medical, Inc. FLL Class II 1985-05-10
K851307 INOX DRY HEAT STERILIZER Broadwest Corp. KMH Class II 1985-05-09
K851316 ABCO SUCTION CANISTER Abco Dealers, Inc. KDQ Class II 1985-05-08

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