meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
34
Latest Decision
1996-10-11

Clearances · page 84 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K963365 MULTI-PURPOSE MEDICAL TUBE HOLDER Byrd Medical Devices, Inc. KMK Class I 1996-10-11
K953213 COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED) Wembley Rubber Products (M) Sdn Bhd LYY Class I 1996-10-11
K963457 SLEEPER JACKET/HOUDINI SAFETY SLEEPER Skil-Care Corp. FMQ Class I 1996-10-09
K963237 HEELBO ICU 911 BLAZER SLEEVED JACKET Heelbo, Inc. FMQ Class I 1996-10-09
K963108 HEELBO QUILTED TORSO RESTRAINT Hollister, Inc. FMQ Class I 1996-10-09
K962810 GREAT HANDS MITTS Heelbo, Inc. FMQ Class I 1996-10-09
K963460 ROLL BELT Skil-Care Corp. FMQ Class I 1996-10-09
K962778 THE L-BOW ARM RESTRAINT Heelbo, Inc. FMQ Class I 1996-10-09
K963456 LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER Skil-Care Corp. FMQ Class I 1996-10-08
K962497 Q-TIPS, FAICHNEY, PRIVATE LABEL Faichney Medical Co. FLL Class II 1996-10-08
K961769 AIR-MEDEX I Robert Gold Assoc. FNM Class II 1996-10-08
K962042 GLASS SYRINGE Ispg, Inc. FMF Class II 1996-10-08
K963583 MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE Medimop Medical Projects, Ltd. LHI Class II 1996-10-07
K963449 PELVIC HOLDER Skil-Care Corp. FMQ Class I 1996-10-07
K963448 ECONO BELT Skil-Care Corp. FMQ Class I 1996-10-07
K961415 LATEX PATIENT EXAMINATION GLOVE (BLUE) (MODIFICATION) Siam Sempermed Corp., Ltd. LYY Class I 1996-10-07
K963450 SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST Skil-Care Corp. FMQ Class I 1996-10-07
K961602 LATEX PATIENT EXAMINATION GLOVE (PINK) Siam Sempermed Corp., Ltd. LYY Class I 1996-10-07
K962849 CATHETER INSERTION TRAY Medcare Medical Group, Inc. LJS Class II 1996-10-07
K962763 2000 MODULAR THIRTY-NINE Equi-Tron Mfg., Inc. FNL Class II 1996-10-07
K962956 MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM Medi-Ject Corp. KZE Class II 1996-10-07
K963454 CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION BELT Skil-Care Corp. FMQ Class I 1996-10-07
K963447 DOUBLE SUPPORT PONCHO/SLIDER PONCHO Skil-Care Corp. FMQ Class I 1996-10-07
K962739 T.B.Q. Convatec, A Division of E.R. Squibb & Sons LRJ Class I 1996-10-07
K962709 SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/ Sigma Intl. FRN Class II 1996-10-07
K962663 SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET Solopak Medical Products, Inc. MEB Class II 1996-10-04
K963355 SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET Solopak Medical Products, Inc. MEB Class II 1996-10-04
K944036 STERIMASTER AUTOCLAVE Scican FLE Class II 1996-10-02
K962626 PATIENT PROTECTIVE LIMB Kenad SG Medical, Inc. FMQ Class I 1996-10-02
K960188 PRESSUREGUARD: SELECTCARE Span-America Medical Systems, Inc. FNM Class II 1996-10-02
K963058 INFANT WARMER SYSTEM Ohmeda Medical FMT Class II 1996-10-01
K962695 PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER Sims Deltec, Inc. LJT Class II 1996-10-01
K955846 MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER Y FLL Class II 1996-10-01
K963243 HEELBO BLAZER SLEEVED JACKET Heelbo, Inc. FMQ Class I 1996-10-01
K963299 HWA-TO ACUPUNCTURE NEEDLES Lhasa Medical, Inc. MQX Class II 1996-09-30
K960055 MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932 Pudenz-Schulte Medical Research Corp. LJS Class II 1996-09-30
K962751 IDEAS' DUAL PORT Ideas For Medicine, Inc. LJT Class II 1996-09-30
K954728 PROD NO. 01-1694 - 4X4 FOAM DRESSING Continental Medical Laboratories, Inc. KMF Class I 1996-09-23
K963300 DBC ACUPUNTURE NEEDLES(SEVERAL TYPES ARE DESCRIBED ON THE FOLLOWING PAGES) Lhasa Medical, Inc. MQX Class II 1996-09-23
K962806 OHMEDA-OHIO CAE PLUS INCUBATOR Ohmeda Medical FMZ Class II 1996-09-20
K961580 PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMS Sims Deltec, Inc. LJT Class II 1996-09-20
K961049 FLEX NEEDLE Lighthouse Medical, Inc. FPA Class II 1996-09-18
K962441 PROSPORE(STEARO FOR STEAM STERILIZER) Raven Biological Laboratories, Inc. FRC Class II 1996-09-18
K962429 SAFETY VEST Johnson & Johnson Professionals, Inc. FMQ Class I 1996-09-18
K960942 LATEX PATIENT EXAMINATION GLOVE Siam Sempermed Corp., Ltd. LYY Class I 1996-09-17
K961928 BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 Biomedix, Inc. FPA Class II 1996-09-16
K963070 VENIPUNCTURE KIT Miller Products and Services FPA Class II 1996-09-13
K962991 BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER Polymedica Industries, Inc. FLL Class II 1996-09-12
K962520 DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND ST-823A Mesure Technology FLL Class II 1996-09-12
K962329 GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10 Global Medical Prods, Inc. FMF Class II 1996-09-12
K960836 DMS-9000 O.R. Solutions, Inc. LRJ Class I 1996-09-12
K962258 ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP Ethicon Endo-Surgery, Inc. GAG Class II 1996-09-11
K962026 PREPOWDER VINYL PATIENT EXAMINATION GLOVES Hong Huang Tang Industrial Co., Ltd. LYZ Class I 1996-09-10
K962614 SHIFA STERILE DISPOSABLE SYRINGES International Regulatory Consultants FMF Class II 1996-09-06
K962740 DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641 Medi-Flex Hospital Products, Inc. KMF Class I 1996-09-06
K962300 CLAMPLESS VALVED CATHETER Bmw Medical, Inc. LJS Class II 1996-09-05
K962581 STOPCOCK MANIFOLD GANGS Baxter Healthcare Corp FMG Class II 1996-08-28
K962801 SAFE MATE I.V. EXTENSION SETS Biological & Environmental Control Laboratories FPA Class II 1996-08-28
K962856 PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR Deknatel, Inc. KDQ Class II 1996-08-28
K962802 SAFE MATE I.V. FLUID DELIVERY SETS Biological & Environmental Control Laboratories FPA Class II 1996-08-28
K960933 BIO-PLEXUS NEEDLE DISPOSAL CONTAINER Bio-Plexus, Inc. FMI Class II 1996-08-28
K962076 MEDLINE PWDER-FREE VIBNYL EXAMIUNATION GLOVES/VINYL GLOVES, STERILE (MDS 192074,5,6) Medline Industries, Inc. LYY Class I 1996-08-23
K960826 CADD-PRIZM MODEL 6100 PUMP Sims Deltec, Inc. FRN Class II 1996-08-23
K963194 ITO ACUPUNCTURE NEEDLES Oms Medical Supplies, Inc. MQX Class II 1996-08-23
K962916 HUA-XIA ACUPUNCTURE NEEDLES Lhasa Medical, Inc. MQX Class II 1996-08-23
K961263 MODEL 1200 ABMULATORY INFUSION PUMP Patient Solutions, Inc. FRN Class II 1996-08-23
K962094 MEDLINE PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES Medline Industries, Inc. LYY Class I 1996-08-23
K961721 STERITEC DISPOSABLE BIOLOGICAL TEST PACK Steritec Products Mfg Co, Inc. FRC Class II 1996-08-23
K962095 MEDLINE POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVES,MEDLINE POWDER-FREE STERILE LATEX EXAMINATION GLOVES Medline Industries, Inc. LYY Class I 1996-08-23
K953958 POWDERFREE BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM Codan Medlon, Inc. LYY Class I 1996-08-20
K962386 SENSOR SHEATH TS1 Radiotherapeutics Corp. FLL Class II 1996-08-20
K962369 TALKING DIGITAL THERMOMETER Ultmost Industrial Corp. FLL Class II 1996-08-20
K953955 POWDERFREE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM Codan Medlon, Inc. LYY Class I 1996-08-20
K953956 BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM Codan Medlon, Inc. LYY Class I 1996-08-20
K962069 MEDLINE PRE-POWDERED NON-STERILE/STERILE VINYL EXAMINATION GLOVES Medline Industries, Inc. LYZ Class I 1996-08-19
K951113 CROSS-CHECKS Steritec Products Mfg Co, Inc. LRT Class II 1996-08-19
K960790 PROSPORE II Raven Biological Laboratories, Inc. FRC Class II 1996-08-16
K962809 SEIRIN ACUPUNCTURE NEEDLES Seirin-America, Inc. MQX Class II 1996-08-16
K961357 PRO-FLEX, DIGITAL THERMOMETER WITH FLEXIBLE PROBE Intelligent Product Limited Co. FLL Class II 1996-08-16
K954736 ACCESS (POWERCLAVE) Mdt Biologic Co. FLE Class II 1996-08-15
K962650 PATIENT LATEX EXAMINATION GLOVES (POWDERED, NON STERILE) Sti Medical Sdn Bhd LYY Class I 1996-08-15
K961365 ENDOCARE ELECTORNIC THERMOMETER SYSTEM Endocare, Inc. FLL Class II 1996-08-15
K960841 POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM Boston Medical Corp. LYY Class I 1996-08-15
K962461 NITRILE POWDER-FREE PATIENT EXAMINATION GLOVES Shen Wei (Usa), Inc. LZA Class I 1996-08-14
K952050 GLOVE, EXAMINATION, VINYL Oak Carolina, Inc. LYZ Class I 1996-08-12
K962600 REXAM SELF-SEAL TYVEK POUCH Rexam Medical Packaging, Inc. KCT Class II 1996-08-09
K961854 SPR PLUS II OVERLAY SYSTEM (CL250/CL212 Gaymar Industries, Inc. FNM Class II 1996-08-09
K954769 BIEGLER BW385L BLOOD & INFUSION WARMER Biegler Medical Products, Inc. LGZ Class II 1996-08-08
K961877 PISTON SYRINGE Univec, Inc. FMI Class II 1996-08-07
K961918 MULTI-TEST II Lincoln Diagnostics, Inc. SCL Class II 1996-08-07
K955766 ADULT-PEDIATRIC TRANSPORT SYSTEM International Biomedical, Inc. FPO Class II 1996-08-07
K955849 DIB INFUSOR Novacon Corp. MEB Class II 1996-08-05
K960318 DIB INFUSOR-RA Novacon Corp. MEB Class II 1996-08-05
K952244 CROSS-CHECKS EO GAS STERILIZATION MONITOR Steritec Products Mfg Co, Inc. JOJ Class II 1996-08-05
K961794 FLUID ADMINISTRATION SET - CONTRAST MANAGER Merit Medical Systems, Inc. FPA Class II 1996-08-01
K962181 HARE MODEL 2000 EZ LOADER MODEL 95555 Dyna Corp. FPO Class II 1996-08-01
K955514 SHARPS SAFE 1.5 & SHARPS SAFE 2.0 Dura-Vac Products MMK Class II 1996-08-01
K960980 ISOLETTE INFANT INCUBATOR Air-Shields, Inc. FMZ Class II 1996-07-30
K960247 ULTRA CARE POWDER FREE HYPOALLERGENIC PATIENT EXAMINATION GLOVE Tillotson Healthcare Corp. LYY Class I 1996-07-29
K960225 POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) PATIENT EXAMINATION GLOVES Tillotson Healthcare Corp. LYY Class I 1996-07-29

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