meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
37
Latest Decision
1994-03-31

Clearances · page 97 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K932895 RIVER PUMP River Medical, Inc. FRN Class II 1994-03-31
K924603 PHARMETRIX MINIPUMP MODEL 5120 Pharmetrix, Inc. FRN Class II 1994-03-31
K931458 MEDIPAK AMBULATORY INFUSION PUMP Medication Delivery Devices, Inc. FRN Class II 1994-03-31
K924527 VIVUS 5000 INFUSION SYSTEM I-Flow Corp. FRN Class II 1994-03-29
K934543 UNIVERSAL CONTROLLER, MODEL 100 Metamed, Inc. LDR Class II 1994-03-29
K923744 CIDEX PLUS 28 DAY SOLUTION Johnson & Johnson Medical, Inc. LRJ Class I 1994-03-29
K924434 CIDEX ACTIVATED DIALDEHYDE SOLUTION Johnson & Johnson Medical, Inc. LRJ Class I 1994-03-29
K924334 CIDEX FORMULA 7* LONG-LIFE ACTIVATED DIALDEHYDE Johnson & Johnson Medical, Inc. MED Class II 1994-03-29
K933550 HYDRASPUN M STERILIZATION WRAP Ahlstrom Dexter FRG Class II 1994-03-29
K933326 LIFECARE PLUMSET VENTED SECONDARY I.V. SET Abbott Laboratories FPA Class II 1994-03-28
K936235 NEEDLESAFE II & NEEDLEGARD II Ingenious Technologies Corp. FMI Class II 1994-03-28
K940293 1.2 MICRON FINAL FILTER WITH EXTENSION TUBE Puritas Health Care, Inc. FPB Class II 1994-03-28
K923189 LUXTRON MODEL 3100/3101/3102 MULTICHANNEL Luxtron FLL Class II 1994-03-28
K940258 SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY) Incutech, Inc. KPE Class II 1994-03-28
K930129 ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER Arrow Intl., Inc. LJS Class II 1994-03-28
K933232 BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED Boehringer Laboratories KDP Class II 1994-03-28
K934105 DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES Surgical Innovations Corp. GAG Class II 1994-03-28
K934188 DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART Deroyal Industries, Inc. GAG Class II 1994-03-28
K940053 INFUSION ADMINISTRATION SET Puritas Health Care, Inc. FPA Class II 1994-03-28
K931798 PATIENT EXAMINATION GLOVES Graintrade , Ltd. LYY Class I 1994-03-28
K934731 MEDSURG STERILE IMAGING PRODUCTS Medsurg Industries, Inc. FMP Class I 1994-03-28
K940256 BIOSHIELD BLUE LATEX GLOVES Chester Labs, Inc. LYY Class I 1994-03-23
K940072 I.V. SET (20 DROPS/ML) Puritas Health Care, Inc. FPA Class II 1994-03-23
K940073 EXTENSION TUBE, EXTENSION TUBE LENGTH 20, & 30 Puritas Health Care, Inc. FPA Class II 1994-03-23
K935131 FAMILY FIRST AID KIT Medical Technologies International, Inc. LYY Class I 1994-03-23
K935812 POWDER-FREE LATEX EXAMINATION GLOVES Shen Wei (Usa), Inc. LYY Class I 1994-03-23
K940254 BIOSHIELD BLUE POWDER FREE GLOVE Chester Labs, Inc. LYY Class I 1994-03-23
K925236 L CATH(R) CATHETER SYSTEM Luther Medical Products, Inc. LJS Class II 1994-03-22
K934792 THEREX LOW-PROFILE PORT Therex Corp. LJT Class II 1994-03-22
K936012 THEREX LOW PROFILE PORT-TITANIUM MODEL Therex Corp. LJT Class II 1994-03-22
K940689 WALL IV EXTENSION TUBE Walla Medical Systems, Inc. FPA Class II 1994-03-22
K934802 THEREX LOW-PROFILE PORT-TITANIUM Therex Corp. LJT Class II 1994-03-22
K926544 PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH Pharmacia Deltec, Inc. FOZ Class II 1994-03-21
K933759 RUBBERCARE LOPRO PATIENT EXAMINATION GLOVES, POWDERED Perusahaan Pelindung Getah (M) Sdn Bhd LYY Class I 1994-03-21
K925566 HOLMES AIR PURIFIER MODELS HAP-240 & HAP-300 Holmes Products Corp. FRF Class II 1994-03-17
K934551 VERIFUSE AMBULATORY PUMP Block Medical, Inc. MEA Class II 1994-03-17
K933965 APEX MEDICAL AIR PUMPS Apex Medical, Inc. FNM Class II 1994-03-17
K933402 TURBO II Kinetic Concepts, Inc. FNM Class II 1994-03-15
K932332 PATIENT EXAMINATION GLOVE - POWDERED Sj Medical Products (M) Sdn Bhd LYY Class I 1994-03-15
K932116 PATIENT EXAMINATION GLOVES (POWDER FREE) Evergrade Healthcare Products Sdn Bhd LYY Class I 1994-03-15
K935274 DIPRIVAN LUER CONNECTOR Ohmeda Medical LHI Class II 1994-03-15
K933224 SLIMFLEX - POWDER FREE LATEX EXAMINATION GLOVES Slim River Latex Sdn. Bhd. LYY Class I 1994-03-15
K934671 HI-FLO INFUSION PUMP Abbott Laboratories FRN Class II 1994-03-14
K940387 SHIELDTEX STERILE PATIENT EXAMINATION GLOVES Shieldtex Sdn Bhd LYY Class I 1994-03-11
K931529 INFANT WARMER Medix I.C.S.A. FMT Class II 1994-03-11
K934316 GLOVE SEAL, POWDER FREE LATEX EXAMINATION GLOVES Contract Latex Dippers Sdn Bhd LYY Class I 1994-03-11
K936261 CATHETER INSERTION TRAY Medcare Custom Packaging, Inc. FMI Class II 1994-03-10
K940130 STRYKER MODEL 6110 EMERGENCY/POLE STRETCHER Stryker Corp. FPP Class I 1994-03-10
K933526 STERILE WATER Trinity Laboratories, Inc. JOL Class II 1994-03-10
K922110 GO-CLEAN Viva-Tek Assoc., Inc. FRR Class II 1994-03-09
K935256 PATIENT EXAMINATION GLOVES Comfort Rubber Gloves Industries Sdn. Bhd. LYY Class I 1994-03-09
K933810 POWDER FREE LATEX EXAMINATION GLOVES Clydesdale Industries Sdn. Bhd. LYY Class I 1994-03-09
K936052 BRADY MEDICAL PRODUCTS HYSORB(TM) WOUND DRESSING Brady Medical Products Co. KMF Class I 1994-03-07
K935852 COMFIT POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC) Wembley Rubber Products (M) Sdn Bhd LYY Class I 1994-03-07
K931377 SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT Mcgaw, Inc. FPA Class II 1994-03-07
K931668 PICC INSERTION TRAY Clinipad Corp. FOZ Class II 1994-03-07
K920740 EPISENSOR PLUS Industrias Palex C/O Dma Med-Chem Corp. CAR Class II 1994-03-07
K926293 ANGIOCOR SIDEHOLE INFUSION CATHETER Angiocor LJS Class II 1994-03-07
K934721 EXTRA CARE Genting Sempurna Sdn. Bhd. LYY Class I 1994-03-07
K932702 ULTAR-SHIELD Medical Resources International, Inc. LYY Class I 1994-03-07
K935389 CONMED VENI-GARD I.V. DRESSING Conmedcorp KMK Class I 1994-03-07
K915649 BARD 500ML RESERVOIR HOLDER C.R. Bard, Inc. FRN Class II 1994-03-07
K926331 3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH Bard Access Systems, Inc. LJS Class II 1994-03-07
K934964 ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR Electromedics, Inc. FLL Class II 1994-03-07
K933004 PEGASUS BIWAVE SYSTEM Pegasus Airwave, Inc. FNM Class II 1994-03-07
K932129 3M AUTOCLAVE TAPES 3M Company JOJ Class II 1994-03-04
K934031 STERILE CENTRAL LINE DRESSING TRAY Surgipro, Inc. FRG Class II 1994-03-01
K933335 RIVER VIAL ADAPTER River Medical, Inc. FMF Class II 1994-03-01
K935948 CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM Convatec, A Division of E.R. Squibb & Sons KGX Class I 1994-03-01
K940284 MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION Meddev International Corp. KZF Class I 1994-02-28
K935777 SHARPSAFE, CAT. NO. 4125 Smiths Industries Medical Systems, Inc. FMI Class II 1994-02-28
K926426 POWDER FREE LATEX EXAMINATION GLOVES Dah Lee Investments, Ltd. LYY Class I 1994-02-28
K935351 A.C. POWER PATIENT LIFT Ken Kemmerer FNG Class II 1994-02-28
K940245 EVACU-SLED Evacu Technologies, Inc. FPP Class I 1994-02-28
K930859 ROBI COMBI Epilady 2000, LLC LJL Class I 1994-02-28
K934409 POWDER FREE LATEX EXAMINATION GLOVES Sjs Supreme, Inc. LYY Class I 1994-02-28
K930217 BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE Baxter Healthcare Corp FMI Class II 1994-02-28
K935776 SHARPSAFE, CAT. NO. 4126 Smiths Industries Medical Systems, Inc. FMI Class II 1994-02-28
K934573 HMP TITANIUM LOW PROFILE PORT Horizon Medical Products, Inc. LJT Class II 1994-02-25
K934640 HMP DUAL POLYSULFONE PORT Horizon Medical Products, Inc. LJT Class II 1994-02-25
K940327 INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW W. L. Gore & Associates, Inc. FMW Class I 1994-02-25
K934504 HMP DUAL TITANIUM PORT Horizon Medical Products, Inc. LJT Class II 1994-02-25
K933986 HMP POLYSULFONE PORT Horizon Medical Products, Inc. LJT Class II 1994-02-25
K930404 DIB INFUSOR Novacon Corp. MEB Class II 1994-02-25
K933990 HMP TITANIUM PORT Horizon Medical Products, Inc. LJT Class II 1994-02-25
K930206 PS MEDICAL IPI ACCESS KIT Pudenz-Schulte Medical Research Corp. LJT Class II 1994-02-25
K925791 EXAC-TEMP & CLINI-TEMP PROBE W/TEMPERATURE SENSOR Deroyal Industries, Inc. FLL Class II 1994-02-25
K931748 CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS Tri-State Hospital Supply Corp. LJT Class II 1994-02-25
K933506 SYRINGE INFUSER Baxa Corp. FRN Class II 1994-02-25
K930930 COAST MEDICAL, INC. RECTAL PROBE Coast Medical Corp. FLL Class II 1994-02-25
K935236 FLOW CONTROLLING EXTENSION SET Block Medical, Inc. LDR Class II 1994-02-24
K923224 KVOI.V. FLUSH SYSTEM Baxter Healthcare Corp FRN Class II 1994-02-24
K926030 KLEAR-TEMP Cas Medical Systems, Inc. FMT Class II 1994-02-24
K933316 THEREX LOW-PROFILE PORT DETACHED CATHETER SYSTEM Therex Corp. LJT Class II 1994-02-23
K933350 THEREX LOW-PROFILE PORT 1.5MM I.D. X 2.7MM O.D. DETACHED CATHETER SYSTEM Therex Corp. LJT Class II 1994-02-23
K932512 MULTI-PORT MANIFOLD Baxter Healthcare Corp FMG Class II 1994-02-22
K931729 I.V. START KIT Carapace, Inc. FOZ Class II 1994-02-22
K931472 CAREJECT DISPOSABLE SYRINGE AND NEEDLE Carewell Mediproducts, Ltd. FMF Class II 1994-02-22
K940296 SAFE CONNECTOR Icu Medical, Inc. FPA Class II 1994-02-22
K935252 K-LOK CATHETER SECUREMENT DEVICE MODIFICATION K-Lok, Inc. KMK Class I 1994-02-18

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