meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
39
Latest Decision
1998-01-29

Clearances · page 78 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K974288 ZEROWET SPLASHIELD Zerowet, Inc. KYZ Class I 1998-01-29
K971844 MCKINLEY OUTBOUND-2 SYSTEM Mckinley, Inc. FPA Class II 1998-01-23
K974682 MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP Biological Controls, Inc. FRF Class II 1998-01-23
K974471 PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A Sims Deltec, Inc. LJT Class II 1998-01-22
K974122 ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA Scientific Health Care MQX Class II 1998-01-22
K974006 BECTON DICKINSON TWINPAK Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 1998-01-22
K974319 MIGHTY AIR Wheelchairs of Kansas FNM Class II 1998-01-22
K972022 ZAK-2000 Cardio Systems, Inc. FNM Class II 1998-01-22
K973830 POWDER FREE PATIENT EXAMINATION GLOVE SAFE GLOVE Safe Glove , Ltd. LYY Class I 1998-01-16
K974768 PDI STERILE LUBRICATING JELLY Nice-Pak Products, Inc. KMJ Class I 1998-01-16
K973497 HUBERLOC Medcare Medical Group, Inc. LJT Class II 1998-01-13
K974083 CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS Ohmeda Medical FMG Class II 1998-01-13
K974527 KHT SEOAM NEEDLE, HAND ACUPUNCTURE NEEDLE American Institute of Koryo Hand Therapy MQX Class II 1998-01-13
K974304 GERMICIDAL CLOTH Convatec, A Division of E.R. Squibb & Sons LRJ Class I 1998-01-13
K974334 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES Hong Huang Tang Industrial Co., Ltd. LYZ Class I 1998-01-09
K970678 THE HARVARD LIBRARY Harvard Apparatus, Inc. MRZ Class II 1998-01-09
K972747 BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320) Propper Mfg. Co., Inc. FRC Class II 1998-01-09
K974589 SMARTVALVE Icu Medical, Inc. FPA Class II 1998-01-09
K973917 CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM Sims Deltec, Inc. FRN Class II 1998-01-09
K971888 GLUTATECT Alden Scientific, Inc. JOJ Class II 1998-01-09
K974431 CHEMO-SPIKE II RECONSTITUTION DEVICE Medi-Dose, Inc. LHI Class II 1998-01-08
K973831 PRE-POWDERED PATIENT EXAMINATION GLOVE Safe Glove , Ltd. LYY Class I 1998-01-06
K974568 CHASE ANASTOMOSIS VISUALIZATION DEVICE Chase Medical, Inc. FQH Class II 1998-01-06
K973020 PATIENT EXAMINATION POWDER-FREE GLOVES Wear Safe Malaysia Sdn. Bhd. LYY Class I 1998-01-06
K974070 PHYSIO/1000 Physio Designs, Inc. FNM Class II 1998-01-06
K964819 SHENG HO Shang HO Industrial Corp. , Ltd. LYY Class I 1998-01-06
K974296 MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED Invacare Corp. FNL Class II 1998-01-06
K974065 POWDER FREE HYPROALLERGENIC EXAMINATION GLOVE (WITH LOW PROTEIN CLAIM) Tillotson Healthcare Corp. LYY Class I 1998-01-06
K974145 V3 VALVE B.Braun Medical, Inc. FPA Class II 1998-01-06
K973851 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630 Alexander Mfg. Co. FRN Class II 1998-01-05
K974443 POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED P.T. Latexindo Tobaperkasa LYZ Class I 1998-01-05
K971366 INCUWARMER Hill-Rom, Inc. FMT Class II 1998-01-05
K973862 PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS Sims Deltec, Inc. LJT Class II 1997-12-29
K974191 EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE Yty Industry (Manjung) Sdn Bhd LYY Class I 1997-12-24
K971339 INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS Becton Dickinson Vascular Access, Inc. FOZ Class II 1997-12-24
K970419 DAXOR MAX100 SYRINGE (MAX100) Daxor Corporation FMF Class II 1997-12-22
K974198 TAKY-SPIKE PLUS Clinico LHI Class II 1997-12-22
K971582 NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET Nipro Medical Corp. LJT Class II 1997-12-22
K971360 SYNTEX Shinemound Enterprise, Inc. LYZ Class I 1997-12-22
K972914 SYVEK PATCH Marine Polymer Technologies, Inc. KGX Class I 1997-12-22
K972555 CATHETER TUNNELER Gerard Medical, Inc. LJS Class II 1997-12-22
K974171 COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS Teva Medical, Ltd. KZH Class II 1997-12-19
K974223 NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES Derlin Company , Ltd. LZA Class I 1997-12-18
K974114 DASH, VITAL GARD Dash Medical Gloves Sdn Bhd LZA Class I 1997-12-18
K973609 IDA-4 AND IPT-MC Bio-Tek Instruments, Inc. FRN Class II 1997-12-18
K974184 HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR) Sri Johani Sdn. Bhd. LYY Class I 1997-12-18
K973913 MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE Pwa Industries Sdn. Bhd. LYY Class I 1997-12-18
K974151 VINYL PATIENT EXAMINATION GLOVES (POWDERED) Shanghai Super Gloves Co., Ltd. LYZ Class I 1997-12-18
K974638 STERITITE SEALED CONTAINERS MODEL SCO4Q Case Medical, Inc. FRG Class II 1997-12-18
K974185 POLYMER NITRILE EXAMINATION GLOVES Sri Johani Sdn. Bhd. LZA Class I 1997-12-18
K974183 POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR) Sri Johani Sdn. Bhd. LZA Class I 1997-12-18
K974218 DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES Ansell Perry LYY Class I 1997-12-18
K974182 POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) Sri Johani Sdn. Bhd. LZA Class I 1997-12-17
K973620 VACUETTE MULTI-SAMPLE NEEDLE Greiner Meditech, Inc. FMI Class II 1997-12-17
K972839 PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET Globe Ent., Inc. FPA Class II 1997-12-17
K972081 SUPERSKIN Medlogic Global Corp. NEC Class I 1997-12-17
K974120 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Shanghai Super Gloves Co., Ltd. LYZ Class I 1997-12-17
K972854 PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY Globe Ent., Inc. FPA Class II 1997-12-17
K974013 EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE Sims Deltec, Inc. FPA Class II 1997-12-17
K973904 POLYMER LATEX EXAMINATION GLOVES Sri Johani Sdn. Bhd. LYY Class I 1997-12-17
K973903 POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR) Sri Johani Sdn. Bhd. LZA Class I 1997-12-17
K973803 FLEXVIEW CO2 BLOWER WITH MIST Ethicon Endo-Surgery, Inc. FQH Class II 1997-12-16
K974254 BENEFIT B3--- SERIES M.C. Healthcare Products, Inc. FNL Class II 1997-12-16
K963659 EXEL I.V. ADMINISTRATION SET Exel Intl. FPA Class II 1997-12-16
K972843 PROTOS BLOOD TRANSFUSION SET Globe Ent., Inc. BRZ Class II 1997-12-16
K974518 NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED Yty Industry (Manjung) Sdn Bhd LYY Class I 1997-12-12
K973871 LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM) Hartalega Sdn Bhd LYY Class I 1997-12-11
K972372 GERM TRAPPER SUCTION TUBE HOLDER Rzv Medical Specialties, Inc. JOL Class II 1997-12-11
K973778 POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES Hartalega Sdn Bhd LYY Class I 1997-12-11
K973619 KENDALL CURITY NON-ADHERING DRESSING Kendall Healthcare Products Co. Div.Of Tyco Health KMF Class I 1997-12-10
K972329 OSMOCYTE RA WOUND DRESSING Procyte Corp. KMF Class I 1997-12-10
K972150 OSMOCYTE ISLAND WOUND DRESSING Procyte Corp. KMF Class I 1997-12-10
K973510 DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML) Immuno-U.S., Inc. FMF Class II 1997-12-08
K973485 CLEARVIEW BLOWER/MISTER Dlp, Inc. FQH Class II 1997-12-08
K973509 KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING Kendall Healthcare Products Co. Div.Of Tyco Health KMF Class I 1997-12-04
K970773 POWDER-FREE EXAM GLOVES Pt. Sarana Indoprotex LYY Class I 1997-12-04
K961289 VAPOPHENE Germiphene Corp. MED Class II 1997-12-04
K973899 UNIFINE PENTIPS Owen Mumford USA, Inc. FMI Class II 1997-12-04
K971362 PERSONAL INFUSOR Science Incorporated MEB Class II 1997-12-04
K972064 MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV Biological Controls, Inc. FRA Class II 1997-12-01
K973429 BIODERM FOAM WOUND DRESSING Bioderm, Inc. KMF Class I 1997-12-01
K973228 STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700) Smith & Nephew, Inc. KMF Class I 1997-11-25
K973103 CHARTERMED TPN-EVA BAGS Chartermed, Inc. KPE Class II 1997-11-24
K971999 PERIPHERALLY INSERTED CENTRAL B.Braun Medical, Inc. LJS Class II 1997-11-24
K973254 J-TIP INJECTOR National Medical Products, Inc. KZE Class II 1997-11-24
K973815 HIGH RISK POWDERED LATEX EXAMINATION GLOVES (BLUE COLOUR) Sri Johani Sdn. Bhd. LYY Class I 1997-11-21
K973801 HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR) Sri Johani Sdn. Bhd. LYY Class I 1997-11-21
K973025 FLUID CENTURION (4-100-00) Northgate Technologies, Inc. FLN Class II 1997-11-20
K973998 VINYL PATIENT EXAMINATION GLOVES POWDER-FREE Everrise Glove Products Co., Ltd. LYZ Class I 1997-11-18
K972549 SIMPULSE Kinetic Concepts, Inc. FNM Class II 1997-11-18
K972539 Hi Coat Powder Free Latex Patient Examination Gloves P.T. Latexindo Tobaperkasa LYY Class I 1997-11-18
K973902 VINYL PATIENT EXAMINATION GLOVES POWDERED Everrise Glove Products Co., Ltd. LYZ Class I 1997-11-18
K973167 POSITIVE PRESSURE CONNECTOR Icu Medical, Inc. FPA Class II 1997-11-17
K971140 VITAL-PORT INFUSION PAL Med Institute, Inc. LJT Class II 1997-11-17
K972284 FLUID MANAGEMENT SYSTEM Belmont Instrument Corp. FRN Class II 1997-11-13
K972446 PEDO CUSH PEDO CUDDLE Cavity Free Kids, Inc. FMQ Class I 1997-11-13
K972138 CARR RIGID CONTAINER SYSTEM Carr Metal Products, Inc. FRG Class II 1997-11-13
K973057 1.4 FR MAPCATH SENSOR STYLET Navion Biomedical Corp. LJS Class II 1997-11-12
K962282 TUTTNAUER PREVACUUM TABLE AUTOCLAVE Tuttnauer U.S.A Co, Ltd. FLE Class II 1997-11-12
K970907 CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE) Getinge/Castle, Inc. FLE Class II 1997-11-12

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