meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
37
Latest Decision
1994-08-03

Clearances · page 95 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K941684 IVEX-2 EXTENSION SET WITH Y-INJECTION SITE Abbott Laboratories FPB Class II 1994-08-03
K943364 CORASSIST WOUND DRESSING Calgon Corp. KMF Class I 1994-08-03
K940953 UMBILI-CATH-S Gesco Intl., Inc. FOS Class II 1994-08-02
K942161 LOCKBOX Pharmacia Deltec, Inc. FRN Class II 1994-08-02
K942807 SURGICAL LIFT SHEET Surgin Surgical Instrumentation, Inc. FSA Class I 1994-08-02
K940870 UMBILI-CATH Gesco Intl., Inc. FOS Class II 1994-08-02
K943151 POWDER-FREE LATEX EXAMINATION GLOVES Shield Gloves Medical Products Sdn Bhd LYY Class I 1994-08-01
K935314 MAYTEX LATEX EXAMINATION GLOVES, POWDERED Maytex Corp. LYY Class I 1994-08-01
K935315 MAYTEX POWDER-FREE LATEX EXAMINATION GLOVES Maytex Corp. LYY Class I 1994-08-01
K942940 ROYAL SHIELD POWDER-FREE LATEX EXAMANATION GLOVES Shield Gloves Manufacturer (M) Sdn Bhd LYY Class I 1994-08-01
K940952 UMBILI-CATH-S-DL Gesco Intl., Inc. FOS Class II 1994-07-29
K940378 COVERLET ADHESIVE DRESSING Beiersdorf, Inc. KGX Class I 1994-07-29
K934513 PROVIDER PUMP SET W/INFUSION CARTRIDGE Abbott Laboratories FPA Class II 1994-07-29
K942283 COMFEEL PLUS TRANSPARENT DRESSING Richard Hamer Assoc., Inc. KMF Class I 1994-07-29
K941176 ALGINATE FIBER Adri/Technam KMF Class I 1994-07-28
K932789 ONE-SITE IV CONNECTOR Care Medical Devices, Inc. FOZ Class II 1994-07-28
K934941 E-Z TEMP II Seven C'S, Inc. KPD Class II 1994-07-27
K942103 L-CATH CATHETER SYSTEM - PORT L-CATH Luther Medical Products, Inc. LJT Class II 1994-07-26
K942275 VIAL VENT FILTER Gelman Sciences, Inc. FPB Class II 1994-07-26
K942024 PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM Pharmacia Deltec, Inc. LJT Class II 1994-07-26
K940400 LYSOL I.C. BRAND DISINFECTANT SPRAY L&F Products LRJ Class I 1994-07-25
K940381 LYSOL I.C. BRAND QUATERNARY CLEANER DISINFECTANT National Laboratories LRJ Class I 1994-07-25
K941731 EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET Incutech, Inc. KPE Class II 1994-07-22
K942747 MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) Engineered Orthopedic Technologies, Inc. KDP Class II 1994-07-21
K942615 SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1994-07-21
K941499 KIT PAK DRESSING CHANGE TRAY Kit Pak, Inc. KGX Class I 1994-07-20
K930680 THERMOSCAN INSTANT THERMOMETER IR-5000 Thermoscan, Inc. FLL Class II 1994-07-20
K941984 SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP Sabratek Corp. FRN Class II 1994-07-19
K942356 MED-EVAC-4 MEDICAL EVACUATION STRETCHER Montery Bay Corp. FPP Class I 1994-07-19
K942886 SIMPULSE SOLO SUCTION IRRIGATOR Davol Inc., Sub. C. R. Bard, Inc. FQH Class II 1994-07-19
K933762 STB YANKAUER SUCKER/NOZZLE Save-T-Breath Distributors C.C. JOL Class II 1994-07-19
K941940 IMMOBILE STERILE AND IMMOBILE A/C STERILE Tnt Moborg Intl. , Ltd. KMK Class I 1994-07-14
K941850 IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE Tnt Moborg Intl. , Ltd. KMK Class I 1994-07-14
K934796 IPI LOW PROFILE IMPORT Pudenz-Schulte Medical Research Corp. LJT Class II 1994-07-14
K941645 BIOPSY TRAY Cush Medical Products FRG Class II 1994-07-14
K940980 CHARGED SUPOR(R) FILTER EXTENSION SET B. Braun of America, Inc. FPB Class II 1994-07-14
K942181 SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116 Medtronic Minimed FPA Class II 1994-07-14
K934167 IPI DUAL LUMEN PORT Pudenz-Schulte Medical Research Corp. LJT Class II 1994-07-14
K932056 DEFEND SELF-SEALING STERILIZATION POUCH Carl Parker Associates, Inc. KCT Class II 1994-07-13
K922702 PROVIDER ANNE INFUSER Abbott Laboratories FRN Class II 1994-07-13
K942086 PATIENT EXAMINATION GLOVE Qrp, Inc. LYY Class I 1994-07-12
K942815 HYDROSKIN WOUND DRESSING Hymedix Intl., Inc. KMF Class I 1994-07-11
K942758 HYPOALLERGEN NON-STER POWDERFREE LATEX PAT EXAM GLOVE Aladan Corp. LYY Class I 1994-07-08
K940686 ELECTRONIC THERMOMETERS American Diagnostic Corp. FLL Class II 1994-07-08
K942313 GUARDIAN GLOVE Guardian Group, Inc. LZC Class I 1994-07-08
K941151 STRATOFUSE PCA II INFUSER Infusion Technology Intl. FRN Class II 1994-07-07
K934946 BILIBLANKET PLUS PHOTOTHERAPY SYSTEM Boc Health Care, Inc. LBI Class II 1994-07-05
K934677 U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE U.S. Medical Corp. FMT Class II 1994-07-05
K935609 4002 INFANT SCALE FOR INCUBATORS AND WARMERS Scale-Tronix, Inc. FMT Class II 1994-07-01
K941943 SURGICAL ADHESIVE TAPE Raleigh Lions Clinic For the Blind, Inc. KGX Class I 1994-06-30
K932054 VINYL EXAMINATION GLOVES Assured Medical Supply Co., Ltd. LYZ Class I 1994-06-30
K941445 EXTENSION SET WITH ANTI-SIPHON VALVE Pharmacia Deltec, Inc. FPA Class II 1994-06-29
K941999 HYPERTONIC SALINE WET DRESSING - STERILE Trinity Laboratories, Inc. KMF Class I 1994-06-29
K920631 BIOJECT JET INJECTION SYSTEM Bioject, Inc. KZE Class II 1994-06-28
K942459 CURASALT HYPERTONIC SALINE DRESSING Kendall Healthcare Products Co. Div.Of Tyco Health KMF Class I 1994-06-27
K933601 FLIPTIP SAFETY NEEDLE Syntuition, Inc. FMI Class II 1994-06-24
K940975 C450/C400 INFANT INCUBATORS Air-Shields, Inc. FMZ Class II 1994-06-23
K934536 VINYL EXAMINATION GLOVES (NON STERILE) Arista Latindo Industrial Ltd. P.T LYZ Class I 1994-06-23
K936265 COMFIT GREEN POWDERED EXAMINATION GLOVES Wembley Rubber Products (M) Sdn Bhd LYY Class I 1994-06-22
K940897 IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET Y FPA Class II 1994-06-22
K936267 COMFIT PINK POWDERED EXAMINATION GLOVES Wembley Rubber Products (M) Sdn Bhd LYY Class I 1994-06-22
K935837 AIRHYTHM HEALTHCARE BED Healthcare Designs FNL Class II 1994-06-21
K933729 ASSURE SELF SEALING STERILIZATION POUCH Sultan Chemists, Inc. KCT Class II 1994-06-21
K935946 POWDER FREE LATEX EXAMINATION GLOVES Cranberry (M) Sdn. Bhd. LYY Class I 1994-06-21
K941451 MRG POWDER FREE LATEX EXAMINATION GLOVES M.R.G. Industries Sdn. Bhd. LYY Class I 1994-06-21
K941900 POWDERED LATEX EXAM GLOVES Tg Medical Sdn. Bhd. LYY Class I 1994-06-21
K941240 DR. BOO POWDER-FREE LATEX EXAM GLOVES Dr. Boo Co., Ltd. LYY Class I 1994-06-21
K932847 CORPAK ENTERAL PUMP Corpak Co. FRN Class II 1994-06-17
K935949 STRYKER 5000 Stryker Medical FNM Class II 1994-06-17
K930072 STERITUBE Jordco, Inc. KCT Class II 1994-06-17
K941095 MEDSAVER SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1994-06-17
K931477 AMERSE Calgon Vestal Div. LRJ Class I 1994-06-17
K934817 SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS Surgical Design Corp. FNM Class II 1994-06-17
K931861 AID, PROMISE POWDER FREE LATEX EXAMINATION GLOVES Taiping Super Holdings Sdn Bhd LYY Class I 1994-06-17
K934252 RPPI STERILIZATION BAGS Royal Precision Plastics, Inc. KCT Class II 1994-06-17
K942323 ONGARD 2 GALLON SHARPS CONTAINER Ongard Systems, Inc. FMI Class II 1994-06-15
K940775 INJECTION CAP Medron, Inc. FOZ Class II 1994-06-15
K941926 MEDI STRUMPF Medi USA, LP DWL Class II 1994-06-15
K942437 PREMIER Premier Medical Industries, Inc. LYY Class I 1994-06-15
K941379 ACE SPORTS TAPE Becton Dickinson Consumer Products KGX Class I 1994-06-13
K935684 IV START KIT Cush Medical Products LRS Class II 1994-06-10
K941106 MODEL TI500 ISOLETTE INFANT INCUBATOR Air-Shields, Inc. FPL Class II 1994-06-10
K931874 RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE Amsco Sterile Recoveries, Inc. FRG Class II 1994-06-10
K940441 DIAL MEDICAL SUPPLY FISTULA NEEDLE SET Dial Medical of Florida, Inc. FOZ Class II 1994-06-10
K931875 AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE Amsco Sterile Recoveries, Inc. FRG Class II 1994-06-10
K935092 CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM Contour Fabricators of Florida, Inc. FMF Class II 1994-06-10
K932477 UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET Baxter Healthcare Corp KPE Class II 1994-06-10
K940117 MID-500 Block Medical, Inc. MEB Class II 1994-06-10
K934119 ENERGIZED DRUG CONTAINER SYSTEM Abbott Laboratories FPA Class II 1994-06-09
K940572 MEROCEL(R) WOUND DRESSING (WITH HEMOSTATIC CLAIM) Merocel Corp. KMF Class I 1994-06-07
K932913 FERRIS POLYMEM HYDROPHILIC WOUND DRESSING Ferris Mfg. Corp. KMF Class I 1994-06-07
K936062 POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC24 Hartalega Sdn Bhd LYY Class I 1994-06-06
K936063 POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC929 Hartalega Sdn Bhd LYY Class I 1994-06-06
K940035 KIT,I.V. START Mason-Keller Corp. LYZ Class I 1994-06-03
K942238 I.V. STARTPAK VASCULAR ACCESS START KIT Bd Becton Dickinson Vacutainer Systems Preanalytic LRS Class II 1994-06-03
K935843 BE-SAFE Mathis-Koolpe, Inc. FMI Class II 1994-06-03
K932047 WAVICIDE MONITOR STRIPS Serim Research Corp. MED Class II 1994-06-02
K940385 NAVIGATOR-MP CATHETER LOCATION INSTRUMENT Navion Biomedical Corp. FOZ Class II 1994-06-02
K922481 BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE Board of Directors, Albert Browne , Ltd. JOJ Class II 1994-06-02
K941032 UNKNOWN Gelman Sciences, Inc. FMF Class II 1994-05-27

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