meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
32
Latest Decision
1988-01-06

Clearances · page 129 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K874467 SET, ADMINISTRATION INTRAVASCULAR Kendall Mcgaw Laboratories, Inc. FPA Class II 1988-01-06
K874523 MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR Mon-A-Therm, Inc. FLL Class II 1988-01-06
K873884 IVAC MODEL 560+ SERIES VOLUMETRIC INFUSION PUMP Y FRN Class II 1988-01-06
K874332 MRI STRETCHER Atomic Products Corp. FPO Class II 1988-01-05
K872774 BETATRON IV SYSTEM Cardiac Pacemakers, Inc. FRN Class II 1988-01-05
K874430 NEEDLE CONTAINER American Medical Technology, Inc. FMI Class II 1988-01-04
K873494 RESERVOIR BAG Marquette Medical, Inc. FRN Class II 1987-12-30
K874184 CHEMO-PORT Hdc Corp. LJT Class II 1987-12-30
K873291 MSI 9000 SERIES BED Med Service, Inc. FNL Class II 1987-12-30
K874022 PHARMASEAL WOUND IRRIGATION DEVICE American Pharmaseal Div. Ahsc FQH Class II 1987-12-30
K873495 PUMP TUBING SET Marquette Medical, Inc. FRN Class II 1987-12-30
K873991 LAKE IRRIGATION TRAY Lake Medical Products, Inc. FMI Class II 1987-12-30
K873489 EMERSON DISPOS THORACIC DRAINAGE SET - 551-8000 J. H. Emerson Co. GCX Class II 1987-12-29
K874582 DESERET SPLITTABLE CATHETER Deseret Medical, Inc. FOZ Class II 1987-12-29
K873522 BARD AMBULATORY PCA DRUG DELIVERY SYSTEM C.R. Bard, Inc. FRN Class II 1987-12-29
K873961 INFUMED 300 AMBULATORY INFUSION PUMP Med Fusion Systems, Inc. FRN Class II 1987-12-29
K874403 A SERIES OF 7 INCH CONTINUOUS INFUSION SETS Quinton, Inc. FPA Class II 1987-12-29
K874186 BOWL, SPONGE, DISPOSABLE, STERILE & NON-STERILE Busse Hospital Disposables, Inc. LDQ 1987-12-29
K874504 MICRO-AIRE PULSE LAVAGE Micro-Aire Surgical Instruments, Inc. FQH Class II 1987-12-29
K872565 DUOFLO DISPENSER Hemaedics, Inc. FMF Class II 1987-12-29
K873729 RATE-MATE NITROGLYCERIN I.V. ADMINISTRATION SET Critikon Company, LLC FPA Class II 1987-12-29
K872516 INFUSION PUMP MODEL 275 Avi, Inc. FRN Class II 1987-12-16
K872514 INFUSION PUMP MODEL 270 Avi, Inc. FRN Class II 1987-12-16
K871807 BARD MICROINFUSER I INSULIN INFUSION PUMP C.R. Bard, Inc. FRN Class II 1987-12-16
K872515 INFUSION PUMP MODEL 470 Avi, Inc. FRN Class II 1987-12-16
K871616 CUSTOM PROCEDURE TRAYS Medical Custom Products, Inc. FMF Class II 1987-12-11
K873700 INSTITUTIONAL BILI LIGHT (IBL) Physician Engineered Products, Inc. LBI Class II 1987-12-11
K873938 IVAC(R) DUAL RATE SET - MODEL C50066 Y FRN Class II 1987-12-11
K873368 TECNOL COMPRESSION KNEE DRESSING Tecnol New Jersey Wound Care, Inc. LLK Class II 1987-12-11
K873806 JDM SP2 SENSOR Jd Monitoring C/O Mackler, Cooper and Gibbs KMI Class I 1987-12-08
K872359 ENVIRACAIRE MODEL EV-1 Enviracaire Corp. FRF Class II 1987-12-07
K873847 CORMED III AMBULATORY INFUSION PUMP C.R. Bard, Inc. FRN Class II 1987-12-07
K873776 IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580+ Y FRN Class II 1987-12-03
K873165 CHEMO-PORT NON-CORING NEEDLES Hdc Corp. FMI Class II 1987-12-03
K872948 URESIL THORA-FLO THORACENTESIS PROCEDURE KIT Uresil Corp. JOL Class II 1987-11-27
K873875 BAXA EXACTA-MED PHARMACY PUMP Baxa Corp., Sub. of Cook Group, Inc. FRN Class II 1987-11-24
K874159 PATIENT TEMPERATURE MONITOR, MODEL 1000 Sonodyne America, Ltd. FLL Class II 1987-11-23
K874024 ACU-MICRO-NEEDLE Acuderm, Inc. FMI Class II 1987-11-23
K873852 INFUSION MANIFOLD Advanced Surgical Products, Inc. FPK Class II 1987-11-23
K873563 APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY Aplicare, Inc. JOL Class II 1987-11-23
K873463 VAN DELLEN ASPIRATING TUBING Van Dellen, Ltd. BYY Class II 1987-11-23
K873464 VAN DELLEN CANNULA Van Dellen, Ltd. JOL Class II 1987-11-23
K873010 SURFACE TEMPERATURE SCANNER Omega Medical Corp. FLL Class II 1987-11-17
K874360 PLASTIC TUBING CONNECTOR American Medical Technology, Inc. FPK Class II 1987-11-17
K872329 INFUSE-A-PORT ADDITIONAL SIZES Shiley Infusaid, Inc. LJT Class II 1987-11-13
K873575 UNIPORT MODELS SD-90, TD-60, TD-70 & TD-90 Healthcare Technologies, Inc. LJT Class II 1987-11-13
K873466 EXCEL PULSED IRRIGATION/SUCTION SYSTEM Stryker Corp. FQH Class II 1987-11-06
K874372 HR(TM) NEEDLE AND SYRINGE Icu Medical, Inc. FMI Class II 1987-11-06
K874404 HI-LO TEMP(R) SKIN TEMPERATURE SENSOR Mallinckrodt Critical Care FLL Class II 1987-11-06
K874454 IV-PUSH, CONSTANT INFUSION PUMP Medical Products Search, Inc. KZD Class I 1987-11-06
K873119 FLEXIFLO COMPANION ENTERAL NUTRITION PUMP Frantz Medical Development, Ltd. LZH Class II 1987-11-05
K873311 DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220 Dale Medical Products, Inc. KMK Class I 1987-11-05
K873894 CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE Travenol Laboratories, S.A. FPA Class II 1987-11-05
K873161 VALLEYLAB MODEL IV7200 INFUSION PUMP Valleylab, Inc. FRN Class II 1987-11-05
K873833 THERMOCOUPLE ADAPTER Mallinckrodt Critical Care FLL Class II 1987-11-03
K872764 IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S75053 Y FRN Class II 1987-11-03
K873885 PHARMACIA DELTEC SUBCUTANEOUS INFUSION SET Pharmacia Deltec, Inc. FPA Class II 1987-11-03
K873735 MEDTRONIC CATHETER ACCESS PORT MODEL 8500 Medtronic Vascular LJT Class II 1987-11-03
K873569 BLOOD NEEDLE HOLDER Sage Products, Inc. FMI Class II 1987-11-03
K873709 3 RING ATTACHMENT FOR SYRINGES Condor Medical FMF Class II 1987-11-03
K874249 BIFURCATED NEEDLE Allergy Laboratories of Ohio, Inc. FMI Class II 1987-11-03
K873444 ENTECH ENTERAL PUMP AND SET Entech, Inc. FRN Class II 1987-11-02
K873525 DEKNATEL TROCAR CATHETER Deknatel, Inc. JOL Class II 1987-11-02
K873517 DEKNATEL THORACIC CATHETER Deknatel, Inc. JOL Class II 1987-11-02
K872643 COX RAPID HEAT TRANSFER STERILIZER Cox Sterile Products, Inc. KMH Class II 1987-10-29
K873213 HICKMAN PLASTIC SUBCUTANEOUS PORT C.R. Bard, Inc. LJT Class II 1987-10-27
K871731 TELSTAR PREWIRE SERIES Telstar Electronics, Inc. LRS Class II 1987-10-27
K871995 MICROS(TM) Controlled Release Technologies, Inc. FPA Class II 1987-10-23
K873588 10CC CONTROL SYRINGE Medi-Plast Intl., Inc. FMF Class II 1987-10-23
K873957 NON-CORING HUBER TYPE NEEDLES Advantage Medical Systems, Inc. FMI Class II 1987-10-23
K873876 PHARMACIA DELTEC BAG SPIKE SET Pharmacia Deltec, Inc. FPA Class II 1987-10-23
K873042 MODEL 1330 EXTENSION SET Pharmacia Deltec, Inc. FPA Class II 1987-10-23
K873555 GORSK SPONGE CONTAINMENT SYSTEM Gorsk, Inc. LWH Class I 1987-10-23
K873873 RESUBMITTED MICRON TRANSFUSION FILTER Travenol Laboratories, S.A. CAK Class II 1987-10-22
K872945 LOOK FLUID DISTRIBUTION SET Look, Inc. FPA Class II 1987-10-22
K871529 TMO-1000, TMO-3000, TMO-10,000 NON-INVAS. THERMO. Western Medical Equipment Corp. FLL Class II 1987-10-22
K871806 PROVIDER IV. MODEL 5000 INFUSION DEVICE Pancretec, Inc. FRN Class II 1987-10-22
K872741 NUTRIPUMP I M, Inc. FRN Class II 1987-10-20
K873050 VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF C.R. Bard, Inc. FOZ Class II 1987-10-20
K872742 WARM WEIGH MODELS I-20/W-30 INFANT SCALE Air-Shields, Inc. FMT Class II 1987-10-20
K872952 ULTRASONIC AIR-IN-LINE DETECTOR (AILD) Imed Corp. FRN Class II 1987-10-20
K870656 IMED(R) 980C VOLUMETRIC INFUSION PUMP Imed Corp. FRN Class II 1987-10-20
K870395 CHURCHILL PARENTERAL NUTRITION BAG - EVA Churchill Corp. KPE Class II 1987-10-15
K872585 CHURCHILL-CATH Churchill Corp. FOZ Class II 1987-10-15
K872923 PARAGON 9000 TILT AND TURN BED Surgi-Med, Inc. FNL Class II 1987-10-14
K872124 CHURCHILL ALBUMIN IV ADMINISTRATION SET Churchill Corp. FPA Class II 1987-10-13
K872876 IMSI/EASY FLOAT MATTRESS Intl. Management Services, Inc. FOH Class I 1987-10-13
K872805 NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY SYSTEM Squibb-Novo, Inc. FMF Class II 1987-10-09
K873280 ENHANCE SUPPORT HOSE Kimberly-Clark Corp. DWL Class II 1987-10-09
K873181 STRETCHER, WHEELED, MECHANICAL Cambridge Technologies, Inc. FPO Class II 1987-10-09
K871177 NTH 101 UL Aragona Medical, Inc. FMT Class II 1987-10-09
K872743 BAXA TUBING SETS (FOR PHARMACY PUMP) Baxa Corp., Sub. of Cook Group, Inc. FMF Class II 1987-10-09
K871705 LOW AIR LOSS BED Integrated Medical Equipment Co. FNM Class II 1987-10-09
K872924 PARAGON 8500 CARDIO-PULMONARY BED Surgi-Med, Inc. FNL Class II 1987-10-09
K872123 CHURCHILL TPN ADMINISTRATION SET Churchill Corp. FPA Class II 1987-10-09
K872524 SAFEWEIGH MAGIC SCALE Health Care Innovations, Inc. FRW Class I 1987-10-09
K871178 MTC XI UL Aragona Medical, Inc. FMT Class II 1987-10-09
K872925 MEGABED 1000 Surgi-Med, Inc. FNL Class II 1987-09-15
K872898 POLYURETHANE CATHETER FOR THE INFUSE-A-PORT Shiley Infusaid, Inc. LJT Class II 1987-09-15
K871615 U. V. GERMICIDAL UNIT Lorvic Corp. KMH Class II 1987-09-11

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