meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
41
Latest Decision
1997-05-02

Clearances · page 81 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K971045 BASIS FLEXIBLE TIP DIGITAL THERMOMETER Polymedica Industries, Inc. FLL Class II 1997-05-02
K971266 SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518 Faulding Medical Device Co. FPA Class II 1997-05-01
K970789 SAFE-CONNECT VIAL DISPENSING SPIKE Faulding Medical Device Co. LHI Class II 1997-05-01
K970442 TARGET VITAL-PORT VASCULAR ACCESS SYSTEM Med Institute, Inc. LJT Class II 1997-04-30
K970380 F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM Pyng Medical Corp. FMI Class II 1997-04-25
K954204 DRAGER INCUBATOR 8000 IC Drager, Inc. FMZ Class II 1997-04-25
K970334 NATURE'S CRADLE Infant Advantage, Inc. FMS Class II 1997-04-25
K960764 SAFE-CATH Scientific Device Manufacturer, LLC FOZ Class II 1997-04-24
K970574 ACUPUNCTURE NEEDLES C.A.I. Industries Corp. MQX Class II 1997-04-24
K970350 EQUI-PISE 1000 MRS Advanced Air Support Consultancy, Inc. FNM Class II 1997-04-22
K970144 VINYL EXAM GLOVE POWERED Hiyi Export Co. LYZ Class I 1997-04-22
K970524 SAFE-CONNECT I.V. EXTENSION SET Faulding Medical Device Co. FPA Class II 1997-04-22
K965095 NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE Ansell Edmont Industrial, Inc. LZA Class I 1997-04-22
K963589 VAIL 3000 BED ENCLOSURE Vail Products, Inc. FNL Class II 1997-04-21
K970485 SMARTSITE ACCESS PIN Ivac Medical Systems FPA Class II 1997-04-21
K971022 CHASE SUCKER Chase Medical, Inc. GCX Class II 1997-04-17
K964556 HR POLYURETHANE PICC AND MIDLINE CATHETERS Johnson & Johnson Medical, Inc. LJS Class II 1997-04-16
K964447 PICC CATHETER/MIDLINE CATHETER Menlo Care, Inc. LJS Class II 1997-04-16
K964918 NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS Critical Device Corp. FPA Class II 1997-04-14
K970255 KIPP MED I.V. MANIFOLD The Kipp Group FPA Class II 1997-04-14
K970275 PATIENT RESTRAINTS Fla Orthopedics, Inc. FMQ Class I 1997-04-11
K970273 PATIENT RESTRAINTS Fla Orthopedics, Inc. FMQ Class I 1997-04-11
K970272 PATIENT RESTRAINT Fla Orthopedics, Inc. FMQ Class I 1997-04-11
K970274 PATIENT RESTRAINTS Fla Orthopedics, Inc. FMQ Class I 1997-04-11
K970370 TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE Tsk Laboratory, Japan FMI Class II 1997-04-10
K970259 E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET Becton Dickinson Vascular Access, Inc. FPA Class II 1997-04-08
K963948 MINIMED INSULIN PUMP, MODEL 505 Medtronic Minimed LZG Class II 1997-04-08
K970287 LUMBAR PUNCTURE KIT B.Braun Medical, Inc. FMJ Class II 1997-04-07
K970074 STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) Hill-Rom, Inc. FMT Class II 1997-04-03
K970271 ALEXANDER MANUFACTURING COMPANY Alexander Mfg. Co. FLL Class II 1997-04-02
K964654 BECTON DICKINSON BLUNT PLASTIC CANNULA Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 1997-04-02
K970438 INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS Baxter Healthcare Corp FPA Class II 1997-04-02
K964435 PRIMARY IV SET Icu Medical, Inc. FMG Class II 1997-04-02
K970800 MAXCESS NEEDLEFREE - Y- SITE (100713) Solopak Medical Products, Inc. FPA Class II 1997-04-02
K964989 CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5) Critical Device Corp. LHI Class II 1997-04-02
K953122 STERITEC DRY HEAT INDICATOR LABEL Steritec Products Mfg Co, Inc. JOJ Class II 1997-04-02
K970434 NEO-PICC Klein-Baker Medical, Inc. LJS Class II 1997-04-01
K961156 ONCE-A-DAY BOWIE AND DICK TEST PACK. Propper Mfg. Co., Inc. JOJ Class II 1997-04-01
K964853 INTRAVIA CONTAINER, EMPTY Baxter Healthcare Corp KPE Class II 1997-03-31
K970479 MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 Medtronic Minimed KZH Class II 1997-03-31
K970737 B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 1997-03-28
K970076 NIPRO DISPOSABLE SOLUTION INFUSION SET Nipro Medical Corp. FPA Class II 1997-03-27
K964387 POINT OF USE II SHARPS-A-GATOR Graphic Controls Corp. MMK Class II 1997-03-27
K970111 JIAWANG POWDER-FREE VINYL EXAMINATION GLOVES Shanghai Jiawang Industrial Co. , Ltd. LYZ Class I 1997-03-27
K970625 POLY-MED Shinemound Enterprise, Inc. LYY Class I 1997-03-27
K964844 CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS Conmedcorp FPA Class II 1997-03-24
K965120 ALLCLENZ WOUND CLEANSER Dpt Laboratories, Ltd. KMF Class I 1997-03-21
K970721 DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM Johnson & Johnson Medical, Inc. MCY Class II 1997-03-21
K960842 LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED) Crocker Industrial Resources Sdn. Bhd. LYY Class I 1997-03-19
K970613 PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE) Sti Medical Sdn Bhd LYY Class I 1997-03-18
K970359 COMBIPROT EMERGENCY ENFUSION DEVICE B.Braun Medical, Inc. LHI Class II 1997-03-18
K970825 BLUE CHIP GERMICIDAL CLEANER & DEODORANT S.C. Johnson Professional LRJ Class I 1997-03-14
K964117 NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE Kawasumi Laboratories Co., Ltd. LJT Class II 1997-03-14
K970079 PROXIMATE DISPOSABLE SKIN STAPLER Ethicon Endo-Surgery, Inc. GAG Class II 1997-03-11
K962605 PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) Surgicot, Inc. FRG Class II 1997-03-11
K970313 PREPOWDERED LATEX EXAMINATION GLOVE Besglove Healthcare Sdn. Bhd. LYY Class I 1997-03-11
K964538 R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM Boston Scientific Corp LJT Class II 1997-03-10
K964231 NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) North American Sterilization & Packaging Co. KMF Class I 1997-03-10
K962545 DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE Sterilization Cassette Systems, Inc. KCT Class II 1997-03-07
K964066 DUAL SLIM PORT IMPLANTED PORT (0654970/0654940) C.R. Bard, Inc. LJT Class II 1997-03-06
K962327 SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE Sekure Seat Corp. FMQ Class I 1997-03-06
K960373 BIOJECTOR 2000 MODEL 1B02000 Bioject, Inc. KZE Class II 1997-03-05
K965155 LATEX EXAM GLOVES P.T. Irama Dinamika Latex LYY Class I 1997-03-05
K964966 V-CATH Hdc Corp. FOZ Class II 1997-03-05
K970152 BIOPSY TRAY Medcare Medical Group, Inc. FRG Class II 1997-03-05
K930683 EZTEST-GAS Sgm Biomedical, Inc. FRC Class II 1997-03-04
K963257 PERIPHERALLY INSERTED MEDLINE CATHETER Arrow Intl., Inc. LJS Class II 1997-03-04
K962755 STRYKER ENCORE STERILIZER Stryker Corp. FLE Class II 1997-03-04
K965030 BRANNON ARTERIO-VENOUS PORTSYRINGE Vascular Logics, Inc. FMF Class II 1997-03-04
K945117 DELTA Pelton & Crane Co. FLE Class II 1997-02-28
K964876 SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET Vlv Associates, Inc. FPA Class II 1997-02-28
K964968 MR EXTENSION SET (001) University of Michigan FPA Class II 1997-02-27
K964845 JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING Jinhua Latex Products Factory LYY Class I 1997-02-27
K964847 NINGBO YUJIANG LATEX EXAMINATION GLOVES, POWDER-FREE, WITH PROTEIN LABELING Ningbo Yujiang Plastic & Rubber Co. , Ltd. LYY Class I 1997-02-27
K963351 LIFESHIELD BLUNT CANNULA Abbott Laboratories FMI Class II 1997-02-26
K961862 MODELS IDA-2 PLUS AND IPT-1 Bio-Tek Instruments, Inc. FRN Class II 1997-02-26
K964181 SPONGETRAC Surgitrac Corp. MRL Class I 1997-02-26
K965208 POLYFIN EXTENSION SET, MODELS 126 AND 128 Medtronic Minimed FPK Class II 1997-02-26
K964850 SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER Baxter Healthcare Corp FPA Class II 1997-02-25
K964782 MEDRAD CONTRAST HOLDER Medrad, Inc. FOX Class I 1997-02-25
K963841 EZTEST Sgm Biotech, Inc. FRC Class II 1997-02-25
K970297 OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE Omni Sales Corp. LYY Class I 1997-02-25
K961982 TRI-FLOW THREE WAY STOPCOCK North, Inc. FMG Class II 1997-02-21
K964833 RMI DUAL FLUID IRRIGATING SYRINGE Research Medical, Inc. KYZ Class I 1997-02-19
K963441 BALDUR VINYL POWDERED GLOVES Hti Trading Group LYZ Class I 1997-02-14
K964800 JIAWANG PRE-POWDERED VINYL EXAMINATION GLOVES Shanghai Jiawang Industrial Co. , Ltd. LYZ Class I 1997-02-14
K963981 VYGON BIONECTOR WITH EXTENSION SET Vygon Corp. FPA Class II 1997-02-14
K965248 BEMIS TWO GALLON SHARPS CONTAINER Bemis Mfg. Co. FMI Class II 1997-02-14
K970225 ALPHA MICRON 20/40 MICROAGGREGATE FILTER Alpha Therapeutic Corp. CAK Class II 1997-02-14
K963466 PEDIATRIC LIMB HOLDER Deroyal Industries, Inc. FMQ Class I 1997-02-13
K964858 BEMIS TWO GALLON CHEMOTHERAPY CONTAINER Bemis Mfg. Co. MMK Class II 1997-02-11
K963830 SHARPS CONTAINER MODEL# SC001 Image Medical, Inc. FMI Class II 1997-02-10
K964628 NITRILE POWDER-FREE EXAMINATION GLOVES Shen Wei (Usa), Inc. LZA Class I 1997-02-10
K964629 VINYL PATIENT EXAMINATION GLOVES Arista Medi Prima LYZ Class I 1997-02-10
K964812 NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET Critical Device Corp. FPA Class II 1997-02-10
K963866 AMBIDERM (WHITE POW LATEX EXAM GLOVES W/ PROTEIN) Supertex Industrial, S.A. DE C.V. LYY Class I 1997-02-10
K970254 SEIRIN PYONEX ACUPUNCTURE NEEDLES Seirin-America, Inc. MQX Class II 1997-02-10
K962084 OMNICAN SYRINGE B. Braun Medical AG FMF Class II 1997-02-10
K970260 SEIRIN JR ACUPUNCTURE NEEDLES Seirin-America, Inc. MQX Class II 1997-02-10
K963804 PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES Hartalega Sdn Bhd LZA Class I 1997-02-10

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