meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
40
Latest Decision
1992-07-30

Clearances · page 104 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K915678 MERIT ADMINISTRATION SET Merit Medical Systems, Inc. FPA Class II 1992-07-30
K914005 FIBEROPTIC TYMPANIC THERMOMETER, MODEL 6000 Daily Medical Products, Inc. FLL Class II 1992-07-30
K910571 BILIBLANKET LIGHT METER Ohmeda Medical LBI Class II 1992-07-28
K915170 PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR Pymah Corp. MED Class II 1992-07-28
K921913 HYPO-GARD Epi Medical Products, Inc. MMK Class II 1992-07-24
K920649 COMPASEP Wilde-USA, Inc. FMC Class I 1992-07-23
K920202 LATEX EXAM/SURGICAL GLOVES Redsun Latex , Ltd. LYY Class I 1992-07-23
K922150 EXAMINATION LAMP Air-Shields, Inc. KZF Class I 1992-07-21
K921201 VITAL-PORT M.R.I. DUAL LUMEN VASCULAR ACCESS SYST. Med Institute, Inc. LJT Class II 1992-07-21
K920248 MODEL SLASE 210 HOLMIUM LASER SYSTEM Sunrise Technologies, Inc. GCX Class II 1992-07-21
K922158 PROTECTOR SYRINGE SAFETY CAP SYSTEM Injectimed, Inc. FMI Class II 1992-07-21
K911636 GENESIS(TM) INFUSION SYSTEM Norman'S MEB Class II 1992-07-17
K915636 GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT. Associated Ent., Inc. LDQ 1992-07-13
K912437 IRRIGATING SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1992-07-13
K921799 PATIENT EXAMINATION GLOVES Consolex Corp. Sdn. Bhd. LYY Class I 1992-07-08
K914733 TTL MEDICATED DRESSING Medimix Products, Inc. KGX Class I 1992-07-01
K921365 NUTRIMIX MICROCOMPOUNDER Abbott Laboratories LHI Class II 1992-06-30
K912471 EAGLE 3000 SDS Amsco Co. FLE Class II 1992-06-26
K915662 BARRIER INTEGRITY MONITOR Incomed, Inc. LDQ 1992-06-25
K921438 DISPOSABLE LATEX EXAMINATION GLOVES Perlink USA, Inc. LYY Class I 1992-06-23
K915646 VIVUS 50 AND VIVUS 100 PERSONAL INFUSER I-Flow Corp. FRN Class II 1992-06-15
K921376 PATIENT EXAMINATION GLOVES Seal Polymer Industries Bhd. LYY Class I 1992-06-15
K915437 CRITICAL CARE HOSPITAL BED (ICU/CCU) Hill-Rom, Inc. FNL Class II 1992-06-11
K910830 INVALIFT American Invalift Corp. FRZ Class II 1992-06-09
K921378 IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE Imed Corp. FRN Class II 1992-06-09
K915831 THERMAL PROBE COVER Vermont Medical, Inc. FMT Class II 1992-06-08
K921703 CONTINU-FLO(R) SOLUTION SET Baxter Healthcare Corp FPA Class II 1992-06-04
K920788 BLOOD ADMINISTRATION SET Douglas Medical Products Corp. BRZ Class II 1992-06-04
K915063 IVAC PC ANIFUSER Y MEA Class II 1992-06-03
K921009 KALTOSTAT FORTEX WOUND DRESSING Calgon Vestal Div. KMF Class I 1992-05-29
K920925 COMFEEL CONTOUR DRESSING Coloplast A/S KMF Class I 1992-05-28
K921072 AVI MODEL 470CI INFUSION PUMP 3M Health Care, Ltd. FRN Class II 1992-05-26
K921073 AVI MODEL 480CI INFUSION PUMP 3M Health Care, Ltd. FRN Class II 1992-05-26
K920805 LIFE LITE EMERGENCY STRETCHER Design Principles, Inc. FPP Class I 1992-05-22
K921775 SPYROFLEX WOUND CLOSURES Polymint Industrial Co. , Ltd. FPX Class I 1992-05-19
K904581 SPORICIDIN BRAND DISINFECTANT SOLUTION Sporicidin Intl. LRJ Class I 1992-05-18
K904579 SPORICIDIN BRAND DISINFECTANT TOWELETTES Sporicidin Intl. LRJ Class I 1992-05-18
K914589 SABRATEK 3030 INFUSION PUMP Sabratek Corp. FRN Class II 1992-05-18
K904580 SPORICIDIN BRAND DISINFECTANT SPRAY Sporicidin Intl. LRJ Class I 1992-05-18
K915828 INJECTION SITE WITH LUER LOCK Baxter Healthcare Corp FPA Class II 1992-05-15
K920058 SUPERGLOVES Sempermed Glove Industries Sdn Bhd LYY Class I 1992-05-14
K920206 POSEY SITTER J. T. Posey Co. KMI Class I 1992-05-14
K915560 LO-PROFILE EXTENSION SET Douglas Medical Products Corp. FPK Class II 1992-05-14
K920812 FAIRBANKS BABY SCALE Fairbanks Scales, Inc. FRW Class I 1992-05-13
K920013 UNI-DOSE SYRINGE PUMP Electrochemical Drug Delivery, Inc. FRN Class II 1992-05-13
K915874 BASKET LITTER CARRIER Bradco Med , Ltd. FPP Class I 1992-05-13
K920700 SEAMLESS LATEX PATIENT EXAM GLOVES Digitcare Corp. LYY Class I 1992-05-11
K920773 DURAFUSE INFUSION PUMP Bd Becton Dickinson Vacutainer Systems Preanalytic FRN Class II 1992-05-08
K910925 DISINFECTION WITH THE COX DRY HEAT STERILIZER Cox Sterile Products, Inc. KMH Class II 1992-05-08
K914180 DESERET(R) FLOW RESTRICTION VALVE Becton Dickinson Vascular Access, Inc. FOZ Class II 1992-05-08
K915477 STERILIZATION BAG, POLYESTER/WRAP Cgs Supplies Corp. KCT Class II 1992-05-08
K915109 RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET Ballard Medical Products FPA Class II 1992-05-08
K915446 STRETCH WRAP Sun Glitz Corp. KGX Class I 1992-05-06
K920422 B-D INTERLINK SYRINGE CANNULA Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1992-04-29
K920103 EPISCOPE, MODEL 47300 Welch Allyn, Inc. KZF Class I 1992-04-28
K915358 PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH Medtronic Vascular KGX Class I 1992-04-28
K920339 DRESSING CHANGE TRAY Medikmark, Inc. FRG Class II 1992-04-23
K920717 NEEDLEGARD II Ingenious Technologies Corp. FMI Class II 1992-04-22
K920174 EASY TOUCH LATEX EAM GLOVES Simpex, Inc. LYY Class I 1992-04-22
K920293 DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY Davis & Geck, Inc. FLE Class II 1992-04-21
K920321 BECTON DICKINSON SAFETY-LOK SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1992-04-20
K912742 ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE Spacelabs, Inc. FLL Class II 1992-04-20
K920444 ULTIMATE Jobst Institute, Inc. DWL Class II 1992-04-20
K920398 CEPTI-SEAL DRESSING CHNG. KIT FOR CENT. VENOUS CAT Medi-Flex Hospital Products, Inc. FMF Class II 1992-04-15
K915842 PATIENT EXAMINATION GLOVE Precious Mountain Ent. Corp. LYY Class I 1992-04-14
K914859 BARTRONIX IN-BED ACTIVITY MONITOR Bartronix KMI Class I 1992-04-13
K914775 TALLEY MICRO SYSTEM/TALLEY RIPPLEBED Talley Group, Ltd. FNM Class II 1992-04-10
K913540 PEDIA-THOR THORACOSTOMY KIT Intl. Medical Devices , Ltd. FMF Class II 1992-04-09
K913541 NEO-THOR THORACOSTOMY KIT Intl. Medical Devices , Ltd. FMF Class II 1992-04-09
K913642 THE BODYGUARDS PLUS HYPO ALLERGENIC LATEX EXAM GLO T.K. Glove Products LYY Class I 1992-04-07
K915495 DESERET POSITIONAL SUTURE WING Bd Becton Dickinson Vacutainer Systems Preanalytic KMK Class I 1992-04-06
K920680 AVI MODEL 275CI INFUSION PUMP 3M Health Care, Ltd. FRN Class II 1992-04-06
K914988 500 INFUSER Excel Medical, Inc. FRN Class II 1992-04-06
K920588 AVI MODEL 3000 INFUSION PUMP 3M Health Care, Ltd. FRN Class II 1992-04-06
K920681 AVI MODEL 285CI INFUSION PUMP 3M Health Care, Ltd. FRN Class II 1992-04-06
K920074 ARJO CENTURY SCALES WITH REMOTE Arjo-Century, Inc. FRW Class I 1992-04-06
K920635 E-Z SET/MINICATH INFUSION SETS Bd Becton Dickinson Vacutainer Systems Preanalytic FOZ Class II 1992-04-06
K912796 SPORE STRIP Raven Biological Laboratories, Inc. FRC Class II 1992-04-02
K915872 LATEX PATIENT EXAMINATION GLOVES Sri Anusham Rubber Industries Pvt., Ltd. LYY Class I 1992-04-02
K914140 GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/JEJUN FEED Bissell Medical Products, Inc. FPP Class I 1992-03-31
K905425 SPORVIEW Spsmedical Supply Corp. FRC Class II 1992-03-27
K915105 FOXELL PLUS MULTIPLE(PERSONAL TOUCH), MODIFICATION Wah-Chang and Stone Lion LYY Class I 1992-03-27
K910777 MDT/CASTLE MODELS S-8 TABLE TOP STEAM STERILIZER Mdt Biologic Co. FLE Class II 1992-03-27
K913891 DISETRONIC(R) INFUSOR Disetronic Medical Systems FRN Class II 1992-03-27
K920782 OLYMPIC TRANS-LITE Olympic Medical Corp. KYT Class I 1992-03-27
K912662 SCALE-TRONIX PLATFORM SCALE Scale-Tronix, Inc. FRW Class I 1992-03-27
K920368 ULCUFLEX HYDROCOLLOID PASTE Industrias Palex C/O Dma Med-Chem Corp. KMF Class I 1992-03-26
K920133 VERSACATH SELECTALUMEN INNER CATHETER Menlo Care, Inc. FOZ Class II 1992-03-26
K920366 ULCUFLEX HYDROCOLOID POWDER Industrias Palex C/O Dma Med-Chem Corp. KMF Class I 1992-03-26
K920182 MARION WINDOW Tnt Moberg Intl. , Ltd. KGX Class I 1992-03-26
K913658 IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD Imed Corp. MEB Class II 1992-03-26
K920028 LANDMARK MIDLINE CATHETER Menlo Care, Inc. FOZ Class II 1992-03-26
K913943 SERIM DISINTEK REAGENT STRIPS Serim Research Corp. MED Class II 1992-03-26
K920128 VERSACATH MAINLINE CENTRAL VENOUS CATHETER Menlo Care, Inc. FOZ Class II 1992-03-26
K920367 ULCUFLEX HYDROCULLOID DRESSING Industrias Palex C/O Dma Med-Chem Corp. KMF Class I 1992-03-26
K920704 STRYKER I.V. CADDY ACCESSORY DEVICE Stryker Medical FPO Class II 1992-03-23
K920694 8000 SERIES VOLUMETRIC PUMP NON-GRAVITY FLOW SET Baxter Healthcare Corp FPA Class II 1992-03-23
K914597 SURGICAL MICROPOROUS TAPE (MICROCEL) Industrias Tuk, S.A. DE C.V. KGX Class I 1992-03-19
K915057 CANN-HOLD O.R. Concepts, Inc. KGX Class I 1992-03-19
K914596 SURGICAL CLOTH TAPE (HEALRITE) Industrias Tuk, S.A. DE C.V. KGX Class I 1992-03-19

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