meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
40
Latest Decision
1993-07-26

Clearances · page 101 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K931946 WELCH ALLYN EARCLEANER Welch Allyn, Inc. KYZ Class I 1993-07-26
K921547 ADVANTAGE Kci FMT Class II 1993-07-23
K930512 SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES Core Dynamics, Inc. GAZ Class II 1993-07-23
K923589 STERILE HYPOALLERGENIC POWDER-FREE LATEX SURG. GLV Tomarc (M) Sdn Bhd LYY Class I 1993-07-23
K926049 DIGITEX, DIGITEX HYPOALLERGENIC Mayer Laboratories LYY Class I 1993-07-22
K931813 NEEDLESAFE HANDGUARD Adrian Anesthesia Systems, Inc. FPA Class II 1993-07-22
K924721 BAXTER SOLUTION ADMINISTRATION SETS Baxter Healthcare Corp FPA Class II 1993-07-20
K924690 VARIOUS NON-STERILE CUSTOM TRAYS/KITS Surgipro Central, Inc. MCY Class II 1993-07-16
K931005 DUKAL SKIN CLOSURE STRIP Dukal Corp. FPX Class I 1993-07-14
K923183 GENESIS SPRAY TIP ATOMIZER Mai FMF Class II 1993-07-13
K924386 PATIENT EXAMINATION GLOVES Wuhrlin Soplamed (M) Sdn Bhd LYY Class I 1993-07-13
K924118 PROPAK Dental Services, Inc. KCT Class II 1993-07-13
K922816 U P CUSTOM DESIGN, INC. COT EQUIPMENT CARRIER Up Custom Design, Inc. FPP Class I 1993-07-13
K932327 THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM Davol, Inc. KDQ Class II 1993-07-13
K925548 FIBRACOL COLLAGEN-ALGINATE DRESSING Johnson & Johnson Medical, Inc. FMF Class II 1993-07-13
K923323 INTERMITTENT INJECTION SITE Kawasumi Laboratories Co., Ltd. FOZ Class II 1993-07-13
K930847 ARGYLE TURKEL SAFETY THORACENTESIS PROC. TRAY Sherwood Medical Co. FMF Class II 1993-07-12
K921322 MORSE ANESTHESIA MANIFOLD Namic FPA Class II 1993-07-09
K915052 LATEX EXAMINATION GLOVES, MODIFICATION-NONPOWDERED Supertex Glove Intl. Corp. LYY Class I 1993-07-09
K925091 IVAC SYRING PUMP MODEL 770 Y FRN Class II 1993-07-08
K920478 TUTTNAUER LSI (AUTOMATIC) Tuttnauer Co. , Ltd. FLE Class II 1993-07-08
K924794 TRANSPARENT ADHESIVE DRESSING Medical Concepts Development, Inc. KGX Class I 1993-07-08
K921751 INFUSE-A-CATH SILICONE CENTRAL VENOUS CATHETER Strato Medical Corp. LJS Class II 1993-07-07
K915273 LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555 Strato Medical Corp. LJT Class II 1993-07-07
K925363 HYPOALLERGENIC MULTI-COMFORT EXAMINATION GLOVES Perusahaan Intan Emas Sdn. Bhd. LYY Class I 1993-07-06
K923905 WOUND DRESSING KIT Kit Pak, Inc. MCY Class II 1993-07-02
K930196 CEPTI-SEAL I.V. PREP KIT Medi-Flex Hospital Products, Inc. LRS Class II 1993-07-02
K924538 IV START KIT Cml, Inc. LRS Class II 1993-07-02
K923782 TRANSFER SET Pacific Device, Inc. LHI Class II 1993-07-02
K922179 CATHETER INSERTION TRAY Medcare Custom Packaging, Inc. FMI Class II 1993-07-02
K922344 OMRON TYMPANIC THERMOMETER MC-500 Omron Healthcare, Inc. FLL Class II 1993-06-29
K915633 MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA S & W Medico Teknik FLL Class II 1993-06-29
K921908 NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE Novo Nordisk Pharmaceuticals, Inc. FMF Class II 1993-06-29
K923361 I.V. START KIT, STERILE, DISPOSABLE Trinity Laboratories, Inc. LRS Class II 1993-06-28
K925685 POWDER FREE LATEX EXAM GLOVES M.M. Rubber Co. , Ltd. LYY Class I 1993-06-25
K926277 POWDER FREE LATEX EXAMINATION GLOVES A.P. Rubber Co., Ltd. LYY Class I 1993-06-25
K926127 SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM Life Medical Sciences, Inc. GAG Class II 1993-06-24
K924433 SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1 Senior Technologies, Inc. KMI Class I 1993-06-24
K920620 FLUORO-SHIELD RADIATION REDUCTION GLOVES Acufex Microsurgical, Inc. LZC Class I 1993-06-22
K923089 EXAMINATION GLOVES POWDER FREE Glovoco (M) Sdn Bhd LYY Class I 1993-06-22
K924051 KIT PAK I.V. START KIT Kit Pak, Inc. LYY Class I 1993-06-22
K925530 INSTRUMENT WARMER Superior Healthcare Group, Inc. FMS Class II 1993-06-18
K923966 SYRINGE ADAPTOR Excel Medical, Inc. LHI Class II 1993-06-18
K924871 MODEL 880 INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. FRN Class II 1993-06-18
K925126 INTERLINK(TM) INJECTION SITE Baxter Healthcare Corp FPA Class II 1993-06-18
K925196 BARD EPIDURAL PUMP C.R. Bard, Inc. FRN Class II 1993-06-18
K925112 BIO CLINIC UNDER PATIENT SCALE Sunrise Medical, Inc. FRN Class II 1993-06-18
K924718 SHROUDED NEEDLE DEVICES Imed Corp. FPA Class II 1993-06-18
K924505 SNAP-LOCK MICROPORT - REVISED Strato Medical Corp. LJT Class II 1993-06-17
K924866 MODEL 285CM INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. FRN Class II 1993-06-17
K924867 285CI INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. FRN Class II 1993-06-17
K924005 SANKEN MAT Shima American Corp. FNM Class II 1993-06-17
K923560 ACCU-DROP I.V. EXTENSION SET Lamtic, Inc. FPA Class II 1993-06-17
K923319 SHAWNEE PRODUCT KIT IV Absentee Shawnee Bandage Group KGX Class I 1993-06-17
K924869 MODEL 480CM INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. FRN Class II 1993-06-17
K924870 MODEL 480CI INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. FRN Class II 1993-06-17
K922177 DISPOSABLE MULTI-PUNCTURE APPLICATOR Allergy Extract Co. SCL Class II 1993-06-17
K924868 MODEL 480 INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. FRN Class II 1993-06-17
K924865 MODEL 285 INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. FRN Class II 1993-06-17
K924811 I.V. START KIT Transidyne General Corp. LRS Class II 1993-06-17
K912351 VARIOUS STERILE CUSTOM DRESSING TRAYS & KITS Surgipro, Inc. LYY Class I 1993-06-17
K923175 SURGICAL INSTRUMENT KIT, DISPOSABLE Ulti-Med Intl., Inc. FMC Class I 1993-06-17
K924872 MODEL 885 INFUSION PUMP, MODIFICATION 3M Health Care, Ltd. FRN Class II 1993-06-17
K925529 WANDER CARE Care Electronics, Inc. KMI Class I 1993-06-16
K926066 BION MUMPS-G ANTIBODY TEST SYSTEM Bion Ent., Ltd. CAR Class II 1993-06-15
K926337 BONE LAVAGE SYSTEM Innovative Surgical Devices Corp. FQH Class II 1993-06-11
K922358 STERLING POWDER FREE PATIENT EXAMINATION GLOVES Perlink USA, Inc. LYY Class I 1993-06-11
K923225 LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME Lorrex Health Products FLK Class II 1993-06-08
K921422 LATEX EXAMINATION GLOVES Vas Latex Co. , Ltd. LYY Class I 1993-06-08
K926031 PRO-PREP I.V. START/SCRUB-PREP/BLOOD CULTURE KIT Brigam Medical, Inc. LRS Class II 1993-06-07
K925021 TPN TRAY (STERILE) Customed, Inc. MCY Class II 1993-06-07
K924809 IRRIGATION TRAY W/ BULB SYRINGE Customed, Inc. KYZ Class I 1993-06-07
K926063 PER-Q-CATH DRESSING CHANGE TRAY Gesco Intl., Inc. MCY Class II 1993-06-07
K920755 L-CATH PEEL AWAY SYSTEM CATHETER Luther Medical Products, Inc. LJS Class II 1993-06-07
K921950 SURGICAL DYNAMICS DISCOGRAPHY SYSTEM Surgical Dynamics, Inc. FMI Class II 1993-06-07
K922637 HORIZON PUMP Y-TYPE BLOOD SET Mcgaw, Inc. FPA Class II 1993-06-04
K925683 NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED) Arista Latindo Industrial Ltd. P.T LYY Class I 1993-06-04
K925710 M.E.D. LIGHT Medical Illumination, Inc. KZF Class I 1993-06-04
K925417 KENDALL HOME RX THERAPEUTIC STOCKING Kendall Healthcare Products Co. Div.Of Tyco Health DWL Class II 1993-06-04
K925576 BURKE BARIATRIC TREATMENT SYSTEM II Burke Mobility Products FNL Class II 1993-06-04
K925856 SAFEHEALTH BRAND LATEX HYPOALLERGENIC EXAM GLOVES Motrend International Corp. LYY Class I 1993-06-01
K923561 AC-901 I.V. INFUSION DROP COUNTER Lamtic, Inc. FLN Class II 1993-05-26
K925675 BATTERY PACK #1015NC Portable Power Systems, Inc. FLL Class II 1993-05-26
K925674 BATTERY PACK #1014NC Portable Power Systems, Inc. FLL Class II 1993-05-26
K924207 AVI(TM) MODEL 232 STANDARD IV ADMINISTRATION SET 3M Health Care, Ltd. FPA Class II 1993-05-26
K924847 DETECTO MODEL 6700 SERIES Cardinal Scale Mfg. Co. FRW Class I 1993-05-24
K920049 MEDIX PC-305 NEONATAL INCUBATOR Medix I.C.S.A. FMZ Class II 1993-05-21
K924968 L-CATH PEEL-AWAY CATHETER SYSTEM Luther Medical Products, Inc. FOZ Class II 1993-05-21
K914378 PERIPHERAL INTERVENOUS CATHETER Medical Profiles, Inc. FOZ Class II 1993-05-20
K930321 BECTON DICKINSON DISPOS. SYRINGES PLUNGER TIP MOD. Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1993-05-17
K924909 THE BODYGUARDS ULTRA POW-FREE HYPO LATEX EXAM GLOV T.K. Glove Products Co., Ltd. LYY Class I 1993-05-17
K923875 SIDEKICK 50 PLUS AND SIDEKICK 100 PLUS I-Flow Corp. FRN Class II 1993-05-13
K923066 FLO-GARD 2100 - 2M8281M Baxter Healthcare Corp LZH Class II 1993-05-13
K922439 LATEX EXAMINATION GLOVES Transcorp LYY Class I 1993-05-13
K925422 BIRD 1000 PV PORTABLE VENTILATOR Bird Products Corp. CBC Class II 1993-05-13
K923653 NEEDLELESS INJECTION CANNULA Arrow Intl., Inc. LJS Class II 1993-05-13
K925537 POWDER-FREE LATEX EXAMINATION GLOVES Safetytech Sdn. Bhd. LYY Class I 1993-05-13
K925534 FULL/SEMI ELECTRIC HOME CARE BED Ivacare Corp. FNL Class II 1993-05-12
K924280 3M TEGASORB THIN HYDROCOLLOID DRESSING 3M Health Care, Ltd. KMF Class I 1993-05-12
K923235 BIOCLUSIVE MVP TRANSPARENT DRESSING Johnson & Johnson Medical, Inc. KGX Class I 1993-05-12

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