meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
36
Latest Decision
1993-10-01

Clearances · page 100 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K921909 STERRAD BI TEST PACK Johnson & Johnson Medical, Inc. FRC Class II 1993-10-01
K930663 IV COMFORT PAD D.J. Scott Mfg., Inc. KMK Class I 1993-09-30
K930602 LATEX EXAMINATION GLOVES, POWDER FREE Tekmedic (M) Sdn Bhd LYY Class I 1993-09-29
K922485 CHEMDI-VHP CHEMICAL INDICATOR American Sterilizer Co. JOJ Class II 1993-09-29
K923321 EDGE SYRINGES AND NEEDLES Trico Intl., Inc. FMF Class II 1993-09-28
K924447 VITAPEN Vitajet Corp. KZF Class I 1993-09-27
K926446 EZ PUMP Alphamed, Inc. FRW Class I 1993-09-27
K925645 SELEC-3 Biomedix, Inc. FPA Class II 1993-09-27
K931197 MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT Meddev International Corp. KZF Class I 1993-09-23
K930420 HUNTER AIR CLEANERS MODEL NOS. 30100/30250/30300 Hunter Fan Co. FRF Class II 1993-09-23
K930557 LATEX EXAMINATION GLOVE Ezmt Valve Co., Inc. LYY Class I 1993-09-23
K923702 INTIMA POINT GUARD INTRAVASCULAR CATHETER Becton Dickinson Vascular Access, Inc. FOZ Class II 1993-09-22
K931441 FENWAL 40 MICRON TRANSFUSION FILTER Baxter Healthcare Corp FPB Class II 1993-09-21
K922670 THE MINIMED MODEL 404-SP AND 504-S Medtronic Minimed FRN Class II 1993-09-16
K931095 SPRING LOADED SYRINGE Acacia, Inc. FMF Class II 1993-09-16
K932462 VENTED NEEDLE Excel Medical, Inc. LHI Class II 1993-09-15
K930625 SANITAS PATIENT LIFT Dutton-Lainson Co. FSA Class I 1993-09-13
K932743 MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION Scott Health Care KGX Class I 1993-09-10
K921901 PORT ACCESS INFUSION SET Kawasumi Laboratories Co., Ltd. FRN Class II 1993-09-10
K932260 FERNO-WASHINGTON AMBULANCE COT, 93ES SQUAD-MATE Ferno FPO Class II 1993-09-09
K931482 STRYKER MPS ACUTE CARE BED Stryker Corp. FNL Class II 1993-09-09
K926318 PATIENT EXAMINATION GLOVES I Ching Ent., Inc. LYY Class I 1993-09-09
K932417 FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT Ferno-Washington, Inc. FPL Class II 1993-09-09
K931886 TISSUE ISOLATION AND RETRIEVAL BAG Advanced Surgical, Inc. KGX Class I 1993-09-07
K930410 DURHAM; LUER LOCK EXTENSION SET Intl. Medical, Inc. FPA Class II 1993-09-03
K930751 DURHAM; EXTENSION TUBE LUER LOCK W/INJECTION SITE Intl. Medical Consultants FPA Class II 1993-09-03
K926123 DUAL CHAMBER MIXING BAG Secure Medical, Inc. KPE Class II 1993-09-03
K930750 DURHAM; ADM. SET-LUER LOCK W/.22 MICRON FILTER Intl. Medical Consultants FPA Class II 1993-09-03
K930406 DURHAM; MIN BORE LUER LOCK EXTENSION SET Intl. Medical, Inc. FPA Class II 1993-09-03
K931375 ABBOTT PLUM XL INFUSION PUMP Abbott Laboratories FRN Class II 1993-09-01
K926097 CYBILNATE(R) UMBILICAL CATHETER Cyex Medical Technologies, Inc. FOZ Class II 1993-08-31
K926191 SIGMA 7000 AND SIGMA70002 Sigma FRN Class II 1993-08-31
K925362 SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET Baxter Healthcare Corp FPA Class II 1993-08-28
K925017 IV PREP KIT (NON-STERILE) Customed, Inc. LRS Class II 1993-08-27
K925018 IV PREP KIT W/O DRESSING (NON-STERILE) Customed, Inc. LRS Class II 1993-08-27
K924192 I.V. START KIT (AHC-50-54954 American Healthcare Corp. KGX Class I 1993-08-27
K931932 DRESSING CHANGE TRAY-MODIFIED Medsurg Industries, Inc. MCY Class II 1993-08-27
K930407 POWDER-FREE LATEX EXAMINATION GLOVES Influx Pacific Sdn. Bhd. LYY Class I 1993-08-25
K931346 FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT Ferno FPL Class II 1993-08-25
K930903 PROBE PERSONAL PREFERENCE NON-STER. PAT. EXAM.GLOV Glove India Private , Ltd. LYY Class I 1993-08-25
K926526 LATEX EXAMINATION GLOVES (POWDER FREE) Rantran, Inc. LYY Class I 1993-08-24
K931632 I.D.A. SYRINGES Pt Hasoon Chandra FMF Class II 1993-08-24
K930139 HYPO-ALLERGENIC PATIENT EXAMINATION GLOVES Shun Thai Rubber Gloves Industry Co., Ltd. LYY Class I 1993-08-24
K931645 HALUX TASKLIGHT Burton Medical Products Corp. KZF Class I 1993-08-20
K931132 CADD-MICRO(TM) MODEL 5900 AMBULATORY INFUSION PUMP Pharmacia Deltec, Inc. FRN Class II 1993-08-20
K930514 SURGIC-ALERT MONITOR Novatec Medical Products, Inc.--Glove Monitor LDQ 1993-08-19
K930781 INFUSION PUMP Y FRN Class II 1993-08-19
K922618 BOWRON G.L. Bowron & Co. , Ltd. FMZ Class II 1993-08-19
K931026 MI-5 DIAGNOSTIC LIGHT Medical Illumination, Inc. KZF Class I 1993-08-19
K931646 MI-4 VARIABLE SPOT LIGHT Medical Illumination, Inc. KZF Class I 1993-08-19
K925244 SENSICARE POWDER FREE MEDICAL GLOVE Bd Becton Dickinson Vacutainer Systems Preanalytic LYZ Class I 1993-08-19
K926435 COMFORTADE Sensible Products FNL Class II 1993-08-19
K925930 MPC-150 MALE TO MALE LUER ADAPTER Molded Products, Inc. FPA Class II 1993-08-16
K930238 BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS Prolac, Inc. HFS Class I 1993-08-16
K925311 TRILOGY INFUSION PUMP Ivion Corp. FRN Class II 1993-08-16
K930995 POWDERED EXAMINATION GLOVES P.T. Healthcare Glovindo LYY Class I 1993-08-16
K926059 3M MODEL 200RT RATE TAPER INFUSION PUMP 3M Health Care, Ltd. FRW Class I 1993-08-16
K925927 MPC-1000 INJECTION CAP/PLUG Molded Products, Inc. FPA Class II 1993-08-16
K926058 3M MODEL 280RT RATE TAPER INFUSION PUMP 3M Health Care, Ltd. FRW Class I 1993-08-16
K926119 EXEL HUBER INFUSION SET ROTATING WING Exel Intl. FPA Class II 1993-08-11
K922441 SURESEAL BANDAGE Gainor Medical Europe, Ltd. KGX Class I 1993-08-10
K930459 BARD MINI-INFUSER 1500 & 3000 Bard Medsystems Div. FRN Class II 1993-08-10
K931912 IRRIGATING BLUNT DISSECTOR Mayaguez Medical Center KYZ Class I 1993-08-10
K932602 ADHESIVE BANDAGES Aso Corp. KGX Class I 1993-08-09
K925937 WELLS LAMONT HANDAGES/MED WRAP DRESSINGS Wells Lamont Corp. KMF Class I 1993-08-09
K926380 ALTA DRESSING FRAME Alta Medical Products, Inc. KMF Class I 1993-08-06
K930791 AMERICAN POWER CONVERSIONS, BACK-UPS 600 Bio Clinic Co. FMF Class II 1993-08-06
K930626 SANITAS PATIENT SCALE Dutton-Lainson Co. FRW Class I 1993-08-06
K930468 3M INCONTINENCE BARRIER FILM, PRODUCT SERIES 336X 3M Health Care, Ltd. KMF Class I 1993-08-06
K931565 MEROCEL WOUND DRESSING Merocel Corp. KMF Class I 1993-08-06
K924570 OEM MULTI-VAC POWERED SUCTION PUMP Oem Medical Div. GCX Class II 1993-08-05
K921389 POWDERFREE NATURAL LATEX GLOVES Arista Latindo Industrial Ltd. P.T LYY Class I 1993-08-05
K925058 BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET C.R. Bard, Inc. FPA Class II 1993-08-03
K924556 PATIENT EXAMINATION GLOVE Cenland Industries Sdn Bhd LYY Class I 1993-08-03
K922714 UNIVERSAL IRRIGATION & SUCTION TUBING SET Ximed Medical Systems JOL Class II 1993-08-03
K921050 ULTRAFLO RATESAVER PLUS INFUSION PUMP Clinical Systems, Inc. FRN Class II 1993-08-03
K920063 DISETRONIC DOLOMAT PUMP Disetronic Medical Systems FRW Class I 1993-08-03
K925430 LO-PROFILE EXTENSIONSET W/ .22 MICRON FILTER Douglas Medical Products Corp. FPA Class II 1993-08-03
K922103 IAB ANCHOR Datascope Corp. KMK Class I 1993-08-03
K933041 COLD CD ASP MODULE, ITE Electone, Inc. LRS Class II 1993-08-02
K930673 PREMIUM Kinetic Concepts, Inc. FNM Class II 1993-08-02
K926403 PRO-2000 LOW AIR LOSS THERAPY BED Ch Administration, Inc. FNM Class II 1993-07-30
K925228 IVAC 59 SERIES UNIVERSAL SET W/ ANTI-FREE FLOW VAL Y FPA Class II 1993-07-30
K920912 THE MEDIC TM Medical and Environment Designs, Inc. GCX Class II 1993-07-30
K930855 REPLACEMENT CAP Douglas Medical Products Corp. FPA Class II 1993-07-30
K924677 STRATO MEDICAL INFUSE-A-CATH POLYURE CEN VEN CATH Strato Medical Corp. LJS Class II 1993-07-30
K925446 BARD SAFE SAMPLING DEVICE C.R. Bard, Inc. FMI Class II 1993-07-29
K924511 MONOJECT(R) 6 CC SAFETY SYRINGE Sherwood Medical Co. FMF Class II 1993-07-29
K924748 VITAL-PORT VASC ACCESS 901OP/911OP/9012P/9112P Med Institute, Inc. LJT Class II 1993-07-28
K924337 PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS Deknatel, Inc. GCX Class II 1993-07-28
K921902 PORT ACCESS NEEDLE Kawasumi Laboratories Co., Ltd. LJT Class II 1993-07-28
K923448 EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG Healthtek, Inc. KPE Class II 1993-07-28
K925066 PNEUMATIC IRRIGATION STANDARD Arthrodyn, Inc. FOX Class I 1993-07-28
K925651 LIFE ISLAND 21 Keisei (Usa) Co., Ltd. FNM Class II 1993-07-27
K926140 VACUUM POWER BODY FLUID SUCTION APPARATUS Hill-Rom, Inc. KDP Class II 1993-07-27
K926045 SKYTRON LIFE ISLAND 21 Skytron, Div. the Kmw Group, Inc. FNM Class II 1993-07-27
K930234 FLH1768M SERIES HOSPITAL BED Bertec Medical, Inc. FNL Class II 1993-07-27
K926184 DOUGLAS MEDICAL PRODUCTS, INC. VENTED SPIKE ADAPT Douglas Medical Products Corp. FPA Class II 1993-07-27
K925219 IVION ADMIN SETS W/FLOW CLIPS Ivion Corp. FPA Class II 1993-07-27
K924275 RESTRAINING STRETCHER Dms FPP Class I 1993-07-27

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