meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
30
Latest Decision
1997-02-10

Clearances · page 82 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K961552 CVP POLYURETHANE CATHETER Abbott Laboratories FOZ Class II 1997-02-10
K962737 AMBIDERM (COLOR POW LATEX EXAM GLOVES W/ PROTEIN) Supertex Industrial, S.A. DE C.V. LYY Class I 1997-02-07
K964148 PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVES Hartalega Sdn Bhd LZA Class I 1997-02-07
K964964 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES Sunmax Enterprise Shanghai Co. , Ltd. LYZ Class I 1997-02-07
K964401 KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4) Ludlow Technical Products FMT Class II 1997-02-06
K964614 ULTRAFERA WOUND DRESSING American White Cross, Inc. KMF Class I 1997-02-06
K964851 ENTRACARE THERMOMTER MODEL 1000 Entracare Corp. FLL Class II 1997-02-03
K962942 TOTALCARE Hill-Rom, Inc. FNL Class II 1997-02-03
K964455 POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333 Medtronic Minimed FPA Class II 1997-01-30
K964456 POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367 Medtronic Minimed FPA Class II 1997-01-30
K961521 PATIENT EXAMINATION GLOVE Shanghai PT Plastics Enterprise Company, Ltd. LYZ Class I 1997-01-30
K961975 DISETRONIC D-MODEM Disetronic Medical Systems FRN Class II 1997-01-30
K964529 CW ACUPUNCTURE NEEDLES Lhasa Medical, Inc. MQX Class II 1997-01-30
K953938 STERILEMAX Barnstead/Thermolyne Corp. FLE Class II 1997-01-30
K964384 MODEL D-290P ADMINISTRATION SET Patient Solutions, Inc. FPA Class II 1997-01-27
K964817 DERLIN Derlin Company , Ltd. LYY Class I 1997-01-24
K963701 SOMA SAFE ENCLOSURE Nova Technology Corp. FNL Class II 1997-01-24
K963331 MEDTEXX Regalfield Sdn. Bhd. LYY Class I 1997-01-24
K964317 FOXELL, MEDIGUARD, PLUS MULTIPLE BRAND NAMES Nantong Ruchang Latex Products Co., Ltd. LYY Class I 1997-01-24
K950422 FIRST TOUCH DISPOSABLES TEMPERATURE PROBES First Touch Disposables, Inc. FMT Class II 1997-01-23
K963474 TUXEDO VEST RESTRAINT Deroyal Industries, Inc. FMQ Class I 1997-01-22
K964246 NOVABED PATIENT TRANSFER SYSTEM Nova Technology Corp. FNL Class II 1997-01-22
K963476 DISPOSABLE LIMB HOLDER Deroyal Industries, Inc. FMQ Class I 1997-01-22
K963468 RESTRICTIVE LIMB HOLDER Deroyal Industries, Inc. FMQ Class I 1997-01-22
K964283 AUTOPRIME Arbor Technologies, Inc. FPB Class II 1997-01-22
K962179 STAT IM 5000 CASSETTE AUTOCLAVE Scican FLE Class II 1997-01-13
K963674 LUMEX AIR Lumex, Inc. FNM Class II 1997-01-10
K962001 MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE Manan Medical Products, Inc. FMI Class II 1997-01-10
K960966 HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588 Sunbeam-Oster Household Products FRF Class II 1997-01-10
K964321 GLOVE, PATIENT EXAMINATION, VINYL (POWDERED) Shijiazhuang Hongray Plastic Products Co., Ltd. LYZ Class I 1997-01-09
K964643 SURETEMP Diatek Instruments, Inc. FLL Class II 1997-01-09
K954331 PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) Pall Biomedical Products Co. FPB Class II 1997-01-09
K962585 UNIT-MATT 5000 PRESSURE RELIEF SYSTEM United Medical Equipment, Inc. FNM Class II 1997-01-07
K963620 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS 9th Wave, Inc. FNM Class II 1997-01-07
K964049 FIRST MIDCATH CATHETER WITH DUAL LUMENS Becton Dickinson Vascular Access, Inc. FOZ Class II 1997-01-06
K964103 OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS Tournier-Bottu S.A. DWL Class II 1997-01-06
K963595 SERAGARD VASCULAR ACCESS DEVICE Cutting Edge Technologies, Inc. FMI Class II 1997-01-06
K964050 FIRST MIDCATH CATHETER Becton Dickinson Vascular Access, Inc. FOZ Class II 1997-01-06
K964048 FIRST MIDCATH CATHETER KIT Becton Dickinson Vascular Access, Inc. FOZ Class II 1997-01-06
K963467 ROLL BELTS Deroyal Industries, Inc. FMQ Class I 1997-01-03
K964559 PORTSMART NEEDLE DE-ACCESS ENCLOSURE Jireh, Inc. LJT Class II 1997-01-03
K964515 ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002 M.C. Healthcare Products, Inc. FNL Class II 1996-12-31
K964411 TAKI ACUPUNCTURE NEEDLES Lhasa Medical, Inc. MQX Class II 1996-12-31
K964127 MEDI-VAC FLEXI-CLEAR SUCTION HANDLE Allegiance Healthcare Corp. GCX Class II 1996-12-31
K964016 TIELLE HYDROPOLYMER FOAM DRESSING Johnson & Johnson Medical, Inc. KMF Class I 1996-12-31
K964563 OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE Omni Sales Corp. LYY Class I 1996-12-30
K964545 POWDER FREE VINYL EXAMINATION GLOVE Shanghai Poseidon Plastic Products Co., Ltd. LYZ Class I 1996-12-30
K955425 DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTENT LABELING CLAIM Dash Medical Gloves Sdn Bhd LYY Class I 1996-12-30
K955661 ACU-HALT Glederer & Co., Inc. LDQ 1996-12-30
K964060 COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE Travenol Laboratories (Israel) , Ltd. FMF Class II 1996-12-24
K963972 NEO-CARE DUAL LUMEN UMBILICAL CATHETER Klein-Baker Medical, Inc. FOS Class II 1996-12-24
K962226 PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM Johnson & Johnson Medical, Inc. FOZ Class II 1996-12-23
K964376 CIDE-SWIPES P-100B & CIDE-SWIPES C-100A Mp Scientific, Inc. LRJ Class I 1996-12-23
K960982 MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA Sherwood Medical Co. FMI Class II 1996-12-23
K964519 CURITY THORACENTESIS TRAY Kendall Healthcare Products Co. Div.Of Tyco Health GCX Class II 1996-12-20
K962139 SAFESKIN Safeskin Corp. LZA Class I 1996-12-19
K963465 PELVIC HOLDER Deroyal Industries, Inc. FMQ Class I 1996-12-19
K962518 NITRILE COPOLYMER PATIENT EXAMINATION GLOVES P.T. Irama Dinamika Latex LZA Class I 1996-12-19
K945410 IRT LOCKING SYRINGE Interventional Research Technologies FMF Class II 1996-12-19
K963771 CHLOROPRENE EXAM GLOVES P.T. Irama Dinamika Latex LZA Class I 1996-12-19
K964828 VIREX II 128 GERMICIDAL CLEANER AND DEODORANT S.C. Johnson & Son, Inc. LRJ Class I 1996-12-19
K964835 COVERAGE SPRAY HBV Convatec, A Division of E.R. Squibb & Sons LRJ Class I 1996-12-16
K962230 CELSITE PORT WITH PRECONNECTED CATHETER B.Braun Medical, Inc. LJT Class II 1996-12-16
K964610 TRIAD II DISINFECTANT CLEANER AND DEODORANT S.C. Johnson & Son, Inc. LRJ Class I 1996-12-13
K964749 COVERAGE HBV Convatec, A Division of E.R. Squibb & Sons LRJ Class I 1996-12-13
K964535 VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT S.C. Johnson & Son, Inc. LRJ Class I 1996-12-13
K964613 VIREX II 256 GERMICIDAL CLEANER AND DEODORANT S.C. Johnson & Son, Inc. LRJ Class I 1996-12-13
K962612 BILIBED PHOTOTHERAPY LAMP Medela, Inc. LBI Class II 1996-12-12
K963806 CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T) Bmw Medical, Inc. LJS Class II 1996-12-12
K960771 SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM Rymed Technologies, Inc. FPA Class II 1996-12-10
K954523 THERMOSCAN INSTANT THERMOMETER MODEL IR-6000 Thermoscan, Inc. FLL Class II 1996-12-10
K962625 VITAJET Vitajet Corp. KZE Class II 1996-12-10
K963276 THE SAFETY 1ST DIGITAL PACIFIER Safety 1st, Inc. FLL Class II 1996-12-06
K963906 PATIENT RESTRAINTS Safety Intl., Inc. FMQ Class I 1996-12-02
K963547 THE WRAP IMMOBILIZATION SYSTEM Safe Restraints, Inc. FMQ Class I 1996-12-02
K963603 DERMAGRAN HYDROPHILIC OINTMENT Derma Sciences, Inc. KMF Class I 1996-11-27
K963598 INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS Innovative Technologies , Ltd. KMF Class I 1996-11-27
K963722 IV START KIT Grand Medical Products LRS Class II 1996-11-27
K963719 CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY Grand Medical Products MCY Class II 1996-11-27
K963510 APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM Mellen Air Mfg., Inc. FNM Class II 1996-11-26
K963626 9TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESS 9th Wave, Inc. FNM Class II 1996-11-26
K962623 OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING Procyte Corp. KMF Class I 1996-11-26
K963648 STRYKER SUCTION REGULATOR Stryker Endoscopy GCX Class II 1996-11-26
K963677 9TH WAVE MODEL 200 ALTERNATING PRESSURE PAD 9th Wave, Inc. FNM Class II 1996-11-26
K953252 DISPOSABLE SCALP VEIN INFUSION SET Myco Medical Supplies, Inc. FOZ Class II 1996-11-26
K963434 VISCOUS FLUID SYSTEM Escalon Trek Medical MRH Class II 1996-11-25
K963260 DRESSING CHANGE TRAYS Busse Hospital Disposables, Inc. FMF Class II 1996-11-22
K963564 PERSONAL LIMB HOLDER (24444-200,300,24444-KIT) Tecnol Medical Products, Inc. FMQ Class I 1996-11-22
K963552 QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350) Tecnol Medical Products, Inc. FMQ Class I 1996-11-22
K963211 UNISEAL GLOVES (LOW PROTEIN,POWDER FREE) American Healthcare Products, Inc. LYY Class I 1996-11-22
K963430 PROTECTIVE RESTRAINT (VEST RESTRAINT) Kenad SG Medical, Inc. FMQ Class I 1996-11-22
K963442 JACKETS AND VESTS J. T. Posey Co. FMQ Class I 1996-11-22
K963414 MULTIPLE BELTS J. T. Posey Co. FMQ Class I 1996-11-22
K963436 RESTRAINT ACCESSORIES J. T. Posey Co. FMQ Class I 1996-11-22
K963410 POSEY STRAIGHT JACKETS J. T. Posey Co. FMQ Class I 1996-11-22
K963559 WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010) Tecnol Medical Products, Inc. FMQ Class I 1996-11-22
K963421 PROTECTIVE RESTRAINT (WAIST HOLDER) Kenad SG Medical, Inc. FMQ Class I 1996-11-22
K963485 SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB HOLDER,VINYL LIMB HOLDER,NYLON BED RESTRAINS Humane Restraint, Inc. FMQ Class I 1996-11-22
K963422 PROTECTIVE RESTRAINT (PROTECTIVE MITT) Kenad SG Medical, Inc. FMQ Class I 1996-11-22
K963563 ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145) Tecnol Medical Products, Inc. FMQ Class I 1996-11-21

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