meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
39
Latest Decision
1994-01-07

Clearances · page 99 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K934942 PATIENT EXAMINATION GLOVE P.T. Surya Milani Plastic Utama LYY Class I 1994-01-07
K934345 POWDER FREE LATEX EXAMINATION GLOVES Vas Latex Co. , Ltd. LYY Class I 1994-01-07
K931659 3 LEAD CONNECTOR Douglas Medical Products Corp. FPA Class II 1994-01-07
K932840 PORT-A-CATH IMPLANTABLE VASCULAR ACCESS SYSTEM Pharmacia Deltec, Inc. LJT Class II 1994-01-05
K932841 PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS Pharmacia Deltec, Inc. LJT Class II 1994-01-05
K932095 PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S Pharmacia Deltec, Inc. LJT Class II 1994-01-05
K933884 STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM Strato Medical Corp. LJS Class II 1993-12-30
K933749 BEECH VERSA LOK Beech Medical Products, Inc. FPA Class II 1993-12-29
K933852 PRO-LOK EXTENSION SET Beech Medical Products, Inc. FPA Class II 1993-12-29
K933732 BEECH PROLOK Beech Medical, Inc. FPA Class II 1993-12-29
K932422 3M TEGADERM HP TRANSPARENT DRESSING 3M Health Care, Ltd. KGX Class I 1993-12-27
K926230 EPIDRESS & DERMASORB HYDROCOLLOID ALGINATE DRESSIN Convatec, A Division of E.R. Squibb & Sons KMF Class I 1993-12-23
K934839 MESALT STERILE DRESSING Richard Hamer Assoc., Inc. KMF Class I 1993-12-22
K934048 GH GLOVES (POWDER FREE) Grafik Hersteller Sdn Bhd LYY Class I 1993-12-22
K934047 GH GLOVES (POWERED) Grafik Hersteller Sdn Bhd LYY Class I 1993-12-22
K926132 ROYAL SHIELD SHIELD GLOVES Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. LYY Class I 1993-12-22
K930632 CHEMOSITE IMPLANTABLE DRUG DELIVERY Device Labs, Inc. KMF Class I 1993-12-22
K930860 HEPA 2500 AIR CLEANER Trion, Inc. FRF Class II 1993-12-22
K924906 POWDER-FREE LATEX EXAMINATION GLOVES Jentera Jaya Sdn Bhd LYY Class I 1993-12-22
K933091 STAGE IV, CM-4000,MATTRESS OVERLAY SYSTEM Creative Medical, Inc. FNM Class II 1993-12-21
K931658 IN-LINE BURETTE SET Douglas Medical Products Corp. FPA Class II 1993-12-21
K931202 STERILIZATION WRAP-STERISHEET Arjo Wiggins Medical, Inc. FRG Class II 1993-12-16
K933050 CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH Critikon Company, LLC FOZ Class II 1993-12-14
K932638 HUBER NEEDLE INFUSION SET Douglas Medical Products Corp. FPA Class II 1993-12-14
K930012 KAWASUMI LABORATORIES K-CUFF Kawasumi Laboratories Co., Ltd. KZD Class I 1993-12-14
K931747 FEVER MONITORING KIT Polymedica Healthcare, Inc. FLL Class II 1993-12-13
K933689 MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSING Kendall Healthcare Products Co. Div.Of Tyco Health KMF Class I 1993-12-13
K924851 STRATO MEDICAL SINGLE LUMEN VALVED CATHETER Strato Medical Corp. LJS Class II 1993-12-13
K932036 LACERATION TRAY Clinipad Corp. FRG Class II 1993-12-13
K932361 BASIC SKIN PREP TRAY Mcbar Industries FMF Class II 1993-12-13
K933151 CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM Contour Fabricators of Florida, Inc. FRG Class II 1993-12-13
K931965 MEDIX PHOTOTHERAPY LAMP Medix I.C.S.A. LBI Class II 1993-12-09
K932757 SECURODRIP (TM) I.V. ARMBOARD Op-Co Medical Products , Ltd. KMK Class I 1993-12-08
K925643 RX FIT MEDICAL STOCKINGS Elastic Therapy, Inc. DWL Class II 1993-12-06
K925588 NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI North American Sterilization & Packaging Co. LDQ 1993-12-03
K925593 NORTEC STERILE WATER FOR DEVICE IRRIGATION North American Sterilization & Packaging Co. LDQ 1993-12-03
K932719 RITTER MODEL 158 AND 159 EXAM LIGHTS Midmark Corp. KZF Class I 1993-12-02
K931626 CARAPACE STERILE COTTON BALLS Carapace, Inc. FRL Class I 1993-12-02
K932714 ELECTRONIC GLOVE INTEGRITY MONITOR (EGIM) Surface Mount Technology, Inc. LDQ 1993-12-01
K932476 PROXIMATE RELOADABLE ARTICULATING LINEAR STAPLER Ethicon Endo-Surgery, Inc. GAG Class II 1993-12-01
K932663 MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES Medline Industries, Inc. FNL Class II 1993-11-30
K931412 POWDER FREE EXAMINATION GLOVES Chatsworth Medical Supply, Inc. LYY Class I 1993-11-30
K932446 INJECTION SITE 3M Health Care, Ltd. FPA Class II 1993-11-29
K935220 CORE PREVENT MATTRESS MODIFICATION Paladin Medical, Inc. FMW Class I 1993-11-29
K930703 ADJUSTABLE BED Maxwell Products, Inc. FNL Class II 1993-11-22
K930266 VINYL EXAMINATION GLOVES Shanghai PM Plastics Enterise Co., Ltd. LYZ Class I 1993-11-22
K925234 BEDSIDE CADDY Researched, Novel Medical Devices (Rn/Md) FMI Class II 1993-11-19
K933901 REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) Richard-Allan Medical GAG Class II 1993-11-19
K931153 ELPER(TM) BARRIER INTEGRITY MONITORING Igea, S.R.L. LDQ 1993-11-18
K931399 PERRY ENHANCED PROTECTION LATEX SURGICAL GLOVE Smith & Nephew Perry LYY Class I 1993-11-18
K924681 GLUTARALDEHYDE MONITORS Pymah Corp. JOJ Class II 1993-11-17
K932572 DIGITAL BABY SCALE MODEL BLB-12 Tanita Corp. of America FRW Class I 1993-11-16
K932649 PHARMAFEED Plasco, Inc. KPE Class II 1993-11-16
K924324 K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE K-1 Medical Products, Inc. FMZ Class II 1993-11-12
K932681 PRESSUREGUARD IV Span-America Medical Systems, Inc. FNM Class II 1993-11-12
K932640 EVA EMPTY MIXING CONTAINER Douglas Medical Products Corp. KPE Class II 1993-11-10
K932641 EMPTY MIXING CONTAINER Douglas Medical Products Corp. KPE Class II 1993-11-10
K932301 FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER Baxter Healthcare Corp FPB Class II 1993-11-10
K930610 TALC DISPENSER SYRINGE Nusurg, Inc. KYZ Class I 1993-11-04
K925418 ENERGIZED CONTAINER SYSTEM Abbott Laboratories FPA Class II 1993-11-03
K930927 DURHAM;T ADAPTOR EXTENSIONSET W/INJECTION SITE Intl. Medical Consultants FPA Class II 1993-11-03
K930974 DURHAM; INJECTION SITE EXTENSION SET, LUER LOCK Intl. Medical Consultants FPA Class II 1993-11-03
K931119 DURHAM; NON CORING WINGED ADMINISTRATION SET Intl. Medical Consultants FPA Class II 1993-11-03
K910007 SPRINGFUSOR 10R Go Medical Industries Pty. , Ltd. FRN Class II 1993-11-02
K932539 DOCTOR DOWN --RESCUE WRAP Three Dog Down KME Class I 1993-11-02
K925990 DUODERM EXTRA THIN CGF DRESSING Convatec, A Division of E.R. Squibb & Sons KMF Class I 1993-10-28
K925991 DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER Convatec, A Division of E.R. Squibb & Sons KMF Class I 1993-10-28
K925993 DUODERM HYDROACTIVE DRESSING Convatec, A Division of E.R. Squibb & Sons KMF Class I 1993-10-28
K932185 SURGICAL SUCTION TIP Tlc Medservices, Inc. JOL Class II 1993-10-27
K932498 MOBILE CARE IV STAND Mobile Care, Inc. FOX Class I 1993-10-27
K923290 COMPUTER - COMPUTERS AND SOFTWARE, MEDICAL USE A Mixed Bag Corp. FRN Class II 1993-10-27
K924517 AVITENE DISPENSER SYRINGE Nusurg, Inc. KYZ Class I 1993-10-27
K933005 AVI MODEL 600 SYRINGE PUMP 3M Health Care, Ltd. FRN Class II 1993-10-25
K931633 POWDER-FREE LATEX PATIENT EXAMINATION GLOVES Tomarc (M) Sdn Bhd LYY Class I 1993-10-25
K933006 AVI INFUSION PUMPS, ADDITIONAL INTENDED USE 3M Health Care, Ltd. FRN Class II 1993-10-25
K926174 MODEL 9100 H.R. INFANT SCALE Acme Medical Scale Co. FRW Class I 1993-10-25
K920438 VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM Via Medical Corp. LZF Class II 1993-10-22
K931406 POWDER-FREE PATIENT EXAMINATION GLOVES P.T. Healthcare Glovindo LYY Class I 1993-10-21
K931581 GLENN BED Kinetic Concepts, Inc. FNL Class II 1993-10-21
K923289 SURVALENT II ORAL THERMOMETER Epson America, Inc. FLL Class II 1993-10-21
K924793 HAN-D-AID Salmon Ent. FMI Class II 1993-10-19
K931019 BECTON DICKINSON LOCKING SAFETY-GARD(TM) IV NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 1993-10-18
K925992 DUODERM TRANSPARENT HYDROCOLLOID DRESSING Convatec, A Division of E.R. Squibb & Sons KMK Class I 1993-10-15
K931491 SIME HEALTH SIME HYPOALLERGENIC Sime Health, Ltd. LYY Class I 1993-10-15
K931427 LATEX EXAMINATION GLOVE POWDER FREE FORMTEX Formtex Medical Sdn. Bhd. LYY Class I 1993-10-15
K924955 MDT/HARVEY MC-8 AND MC-10 Mdt Corp., Inc. FLE Class II 1993-10-15
K912069 AVI MODEL 4225 VENTED PIGGYBACK IV ADMIN SET 3M Avi, Inc. FPA Class II 1993-10-14
K932544 IVAC SPACE SAVER VOLUMETRIC PUMP, MODEL 599 Y FRN Class II 1993-10-12
K922115 IVAC NEEDLELESS INJECTION VALVE Y FPA Class II 1993-10-12
K933144 GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER Imed Corp. FRN Class II 1993-10-12
K930926 DURHAM; Y CHECK SET-LUER LOCK W/INJECTION SITE Intl. Medical Consultants FPA Class II 1993-10-12
K931549 MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP Y FRN Class II 1993-10-12
K924837 DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET Associated Ent., Inc. LDQ 1993-10-12
K921852 4 SURE TM RECTAL TUBE Boston Pacific Medical, Inc. KMO Class I 1993-10-08
K932740 HOMEPUMP NSF Block Medical, Inc. MED Class II 1993-10-06
K924820 HYPOGRIP(TM) Collett Products FMI Class II 1993-10-05
K926440 POWDER-FREE EXAMINATION GLOVE Slim River Latex Sdn. Bhd. LYY Class I 1993-10-05
K924250 PLASTIC LOW PROFILE SUBCUTANEOUS PORT Bard Access Systems, Inc. LJT Class II 1993-10-04
K921910 STERRAD CHEMICAL INDICATOR Johnson & Johnson Medical, Inc. JOJ Class II 1993-10-04
K915682 STERRAD 100 STERILIZATION SYSTEM Johnson & Johnson Medical, Inc. FLF Class II 1993-10-01

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