meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
39
Latest Decision
1994-02-18

Clearances · page 98 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K935297 STRYKER AMBULANCE COT MODEL 6060 Stryker Medical FPO Class II 1994-02-18
K935299 ASTROGLIDE Biofilm, Inc. KMJ Class I 1994-02-18
K932071 I.V. START KIT Clinipad Corp. FOZ Class II 1994-02-17
K935238 ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY Sherwood Medical Co. FRG Class II 1994-02-17
K925039 SAFESNAP SAFETY SYRINGE U.S. Medical Instruments, Inc. MEG Class II 1994-02-16
K934591 CLAVE VIAL ACCESS SPIKE Icu Medical, Inc. FMI Class II 1994-02-16
K924380 MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE Mdt Corp., Inc. MLR Class II 1994-02-16
K933149 INSTRUMENT DETERGENT CONCENTRATE Nobelpharma USA, Inc. FLG Class I 1994-02-16
K922989 WILTEK IRRIGAITON/ASPIRATION TUBE SET Wiltek Medical, Inc. BYY Class II 1994-02-15
K935603 EXTRACORPOREAL TEMPERATURE SENSOR Smiths Industries Medical Systems, Inc. FLL Class II 1994-02-15
K931511 GERITREX STERILE WATER FOR IRRIGATION Geritrex Corp. JOL Class II 1994-02-14
K933751 LIFESHIELD BLOOD COLLECTION DEVICE Sherwood Medical Co. FMI Class II 1994-02-14
K926071 ONCO-VIAL ADAPTER David Bull Laboratories, USA, Inc. LHI Class II 1994-02-14
K933564 SKYTRON EXAM LIGHT Skytron, Div. the Kmw Group, Inc. KZF Class I 1994-02-10
K934561 ONE TIME VIAL ACCESS SPIKE Icu Medical, Inc. FMF Class II 1994-02-10
K935742 SKIN SCRUB TRAY Cush Medical Products FRG Class II 1994-02-10
K935514 VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER Kawasumi Laboratories Co., Ltd. FMI Class II 1994-02-10
K935683 SUTURE REMOVAL TRAY Cush Medical Products FRG Class II 1994-02-10
K935682 LACERATION TRAY Cush Medical Products FRG Class II 1994-02-10
K935685 TRACHEOSTOMY CARE TRAY Cush Medical Products FRG Class II 1994-02-10
K935681 INCISION/DRAINAGE TRAY Cush Medical Products FRG Class II 1994-02-10
K940127 CENTERMARK SECURING WINGS Menlo Care, Inc. KMK Class I 1994-02-09
K935739 SHAVE PREP TRAY Cush Medical Products KCT Class II 1994-02-09
K920039 MEDIJECT DISPOSABLE SYRINGES P.T. Igar Jaya FMF Class II 1994-02-09
K934090 S.S.C. MEDICAL MODEL 5000 SERIES BED Super Sagless Corp. FNL Class II 1994-02-09
K933294 MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES Aesculap, Inc. FPB Class II 1994-02-09
K923730 MODEL 561 C-ARM PROCEDURES STRETCHER Midmark Corp. FPO Class II 1994-02-09
K930655 LATEX EXAMINATION GLOVES Pushpaman Processors, Div. Kanjur Bleaching Co. PV LYY Class I 1994-02-09
K933390 REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG Pharmacia Deltec, Inc. FPA Class II 1994-02-09
K932457 SPYROGEL WOUND DRESSING Polymint Industrial Co. , Ltd. KGX Class I 1994-02-09
K932447 THEREX LOW-PROFILE PORT .6MM I.D 2.3MM O.D. Therex Corp. LJT Class II 1994-02-09
K935622 CUSTOM PLASTIC PACKS Associated Medical FRG Class II 1994-02-07
K931935 ENDPOINT 500 PERACETIC ACID TEST INDICATORS Minntech Corp. JOJ Class II 1994-02-07
K930630 RIGHT ATRIAL CATHETER Akcess Medical Products, Inc. LJS Class II 1994-02-07
K932671 THEREX R-PORT Therex Corp. LJT Class II 1994-02-07
K931669 CARAPACE DEBRIDEMENT KITS Carapace, Inc. FRG Class II 1994-02-07
K931872 THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER American Sterilizer Co. FLF Class II 1994-02-07
K934404 MONOJECT VERTICAL ENTRY SHARPS CONTAINER Sherwood Medical Co. FMI Class II 1994-02-04
K931027 BULLETT PERIPHERAL INFUSION CATHETER Cardio-Dynamics, Inc. FOZ Class II 1994-02-04
K936029 NON-CORNING (HUBER) NEEDLE Therex Corp. FMI Class II 1994-02-04
K935725 EPISEAL ADHESIVE WOUND CLOSURE STRIPS Deroyal Industries, Inc. KGX Class I 1994-02-04
K933060 S-610 & 2-628 WHEELED SHOWER STRETCHERS The Anthros Medical Group FPO Class II 1994-02-04
K935783 MITRAFLEX CAVITY WOUND DRESSING Polymedica Industries, Inc. KMF Class I 1994-02-04
K935628 SHARPSAFE CAT. NO. 4127 Smiths Industries Medical Systems, Inc. FMI Class II 1994-02-04
K930795 MEDIGLOVES, FISHERBRAND, MEDIPRODUCTS GLOVES Medigloves , Ltd. LYY Class I 1994-02-03
K924356 LATEX PATIENT EXAMINATION GLOVES Medi Pure Corp. LYY Class I 1994-02-03
K926405 .9% NORMAL SALINE TUBE/STERILE WATER TUBE Gam-Med Packaging Corp. FOZ Class II 1994-02-03
K911120 DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21 Hamo USA, Inc. MEC Class II 1994-02-03
K935699 COLORED POWDER FREE PATIENT EXAMINATION GLOVES Glove India Private , Ltd. LYY Class I 1994-02-03
K924357 LATEX PATIENT EXAMINATION GLOVES Asia Pacific Latex Sdn Bhd LYY Class I 1994-02-03
K935506 MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION Kawasumi Laboratories Co., Ltd. FMI Class II 1994-02-03
K935832 CHROMOPHARE Berchtold Holding GmbH KZF Class I 1994-02-03
K932010 V.A.D. ACCESS KIT Clinipad Corp. LJT Class II 1994-02-03
K935505 WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER Kawasumi Laboratories Co., Ltd. FMI Class II 1994-02-03
K934088 AUTO SUTURE SHARPS CONTAINER United States Surgical, A Division of Tyco Healthc FMI Class II 1994-02-03
K935033 MULTI-COMFORT POWDER FREE Perusahaan Intan Emas Sdn. Bhd. LYY Class I 1994-02-02
K934408 PARTNERS LATEX EXAM GLOVES PLUS MULTIPLE NAMES Sjs Supreme, Inc. LYY Class I 1994-02-02
K934171 ULTRA SHIELD PF Medical Resources International, Inc. LYY Class I 1994-02-01
K925745 ATI(R) DISP BIOLOGICAL-PLUS TEST PACK Pymah Corp. FRC Class II 1994-02-01
K934382 VCI SUCTION/IRRIGATION TUBING SET Vital Concepts, Inc. JOL Class II 1994-02-01
K925496 ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACK Pymah Corp. FRC Class II 1994-02-01
K933263 COMFIT Wembley Rubber Products (M) Sdn Bhd LYY Class I 1994-02-01
K925006 HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO Deroyal Industries, Inc. FMT Class II 1994-01-31
K935642 EVANS MEDICAL EXTENSION SETS Evans Medical, Inc. FPK Class II 1994-01-28
K933832 ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR Electromedics, Inc. FLL Class II 1994-01-28
K935480 MEDICAL SPECIALTIES NON-CORING NEEDLE ADMIN SETS Evans Medical, Inc. FMI Class II 1994-01-28
K931250 PHYNE-TOUCH PF Medical Resources, Ltd. LYY Class I 1994-01-28
K932991 GUARDIAN AND ANDINO MODELS Coltemp, Inc. FLK Class II 1994-01-28
K935641 0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS Evans Medical, Inc. FPB Class II 1994-01-28
K934259 AC-POWERED MEDICAL EXAMINATION LIGHT Welch Allyn, Inc. KZF Class I 1994-01-28
K934298 KING KRIB Noritage, Inc. FNJ Class I 1994-01-26
K934703 MEDICOOL PROTECTALL Avc Regulatory Compliance/Technical Services LDQ 1994-01-26
K933636 DISPOSE-A-SHEET Belmac Healthcare Corp. KME Class I 1994-01-26
K932856 IRRIGATION ACCESS CAP Mcgaw, Inc. FPA Class II 1994-01-26
K933071 STS 701 TRANSPORT STRETCHER Wy'East Medical Corp. FPO Class II 1994-01-26
K932636 THE TUCKER SLING Tucker Designs, Ltd. FRP Class I 1994-01-26
K923516 COMPOUND BENZOIN TINCTURE USP SEPP Medi-Flex Hospital Products, Inc. KMF Class I 1994-01-25
K920399 COMPOUND BENZOIN TINCTURE USP FREPP Medi-Flex Hospital Products, Inc. KMF Class I 1994-01-25
K930457 MEDIMAC BANDAGE Enquay Pharmaceutical KGX Class I 1994-01-25
K930759 CP & S STERILE BURN SHEET Consolidated Products & Services, Inc. FPY Class I 1994-01-21
K935601 0.22 MICRON FINAL FILTER WITH EXTENSION TUBE Puritas Health Care, Inc. FPA Class II 1994-01-21
K935340 COMFORT PLUS NIPPLE SHIELDS Marshall Baby Products HFS Class I 1994-01-21
K932001 ALLISON MEDICAL SYRINGE Allison Medical, Inc. FMF Class II 1994-01-21
K935341 COMFORT PLUS BREAST SHELLS Marshall Baby Products HFS Class I 1994-01-21
K923299 APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK Aplicare, Inc. KMF Class I 1994-01-18
K930854 SOLUTION SET WITH .2 MICRON FILTER Douglas Medical Products Corp. FPA Class II 1994-01-14
K931521 POWDER FREE LATEX EXAMINATION GLOVES Pt. Abbergummi Medical LYY Class I 1994-01-13
K925004 ALLKARE BARRIER WIPE Convatec, A Division of E.R. Squibb & Sons KMF Class I 1994-01-12
K922997 VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD. Via Medical Corp. LZF Class II 1994-01-11
K935060 BRENNEN MEDICAL STERILE SALINE SOLUTION Brennen Medical, Inc. KMF Class I 1994-01-10
K931550 EZ ADMINISTRATION SET Y FPA Class II 1994-01-10
K933642 R & D BATTERIES, INC. PART # 5003, 5198, 5253 R & D Batteries, Inc. FLL Class II 1994-01-10
K931548 INAMED DEVELOPMENT ASPIRATION TIP Inamed Development Co. GCX Class II 1994-01-10
K933366 I.V. LINK Deville Laboratories, Inc. FPO Class II 1994-01-10
K934813 COMFIT BLUE POWDER FREE EXAMINATION GLOVE Wembley Rubber Products (M) Sdn Bhd LYY Class I 1994-01-07
K934133 PATIENT EXAMINATION GLOVES (POWDER FREE GLOVES) Supergrade Healthcare Products Sdn. Bhd. LYY Class I 1994-01-07
K932509 STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT Strato Medical Corp. LJT Class II 1994-01-07
K932637 SUBCUTANEOUS INFUSION SET Douglas Medical Products Corp. FPA Class II 1994-01-07
K934812 COMFIT GREEN POWDER FREE EXAMINATION GLOVE Wembley Rubber Products (M) Sdn Bhd LYY Class I 1994-01-07
K934546 POWDER-FREE LATEX EXAMINATION GLOVE Powercrest (M) Sdn. Bhd. LYY Class I 1994-01-07

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