meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
42
Latest Decision
1989-01-09

Clearances · page 126 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K882564 RENALIN COLD STERILANT Minntech Corp. LRJ Class I 1989-01-09
K884293 J-TIP INJECTOR SYSTEM California Medical Innovations, Inc. KZE Class II 1989-01-09
K882830 INFUSION PUMP Pemlab Corp. LZF Class II 1988-12-30
K884280 MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET Gempco, Inc. FMT Class II 1988-12-22
K884283 MODEL WC-107 MOBILE NEWBORN BED Gempco, Inc. FMT Class II 1988-12-22
K884285 MODEL WC-115 MOBILE BASSINET Gempco, Inc. FMT Class II 1988-12-22
K881791 STERA DISPOSABLE SYRINGES Excel U.S.A. FMF Class II 1988-12-22
K884985 MODIFIED 10CC SYRINGE CONTROL RING SET Procedure Products, Inc. FMF Class II 1988-12-20
K883993 MODIFIED IMED GEMINI PC-1 INFUSION PUMP Imed Corp. FRN Class II 1988-12-19
K883764 INTRAVASCULAR ADMINISTRATION SET Device Labs, Inc. FPA Class II 1988-12-19
K884749 JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE Johnson & Johnson Patient Care, Inc. KYZ Class I 1988-12-15
K883506 IRRIGATION KIT L H M Ent., Inc. KYZ Class I 1988-12-13
K883983 SANIFIX Iberhospitex, S.A. KGX Class I 1988-12-13
K884497 CONTROL SYRINGE Professional Medical Services FMF Class II 1988-12-12
K884014 FLO-GARD VP Baxter Healthcare Corp FRN Class II 1988-12-12
K884579 UV AIR STERILIGHT Allseasons Environmental Control, Inc. FRA Class II 1988-12-12
K884417 SURGEON'S GLOVE ACCESSORY Allied Signal, Inc. LYY Class I 1988-12-09
K883839 ND:YAG LASER SPECTACLES, MST MODEL #YLS-5 Marlo Surgical Technology KYP Class I 1988-12-09
K884589 FRANTZ MEDICAL SHARPS COLLECTOR Franklin Medical USA, Inc. FMF Class II 1988-12-09
K881454 RETRACTABLE NEEDLE 3CC SYRINGE Kenmar Medical FMF Class II 1988-12-08
K881476 PREEMICARE MODEL D1-X1, SERIES 3000 Preemicare Corp. FMZ Class II 1988-12-08
K883980 LANDMARK VENOUS ACCESS DRIVE (ADDITIONAL SIZES) Menlo Care, Inc. FOZ Class II 1988-12-05
K881813 CHRONODYNAMICS DATA RECORDER (CDR)-100 Chronodynamics, Inc. FLL Class II 1988-12-05
K884630 MULTI-PURPOSE HOLDER Med-Dex Intl. LDQ 1988-11-22
K881867 NEEDLE EJECTOR Howard, Hills & Harsh FMF Class II 1988-11-22
K884626 MODIFIED SLIDING RECONSTITUTION DEVICE Baxter Healthcare Corp LHI Class II 1988-11-22
K881670 ACCUTEMP PLUS Sentry Medical Products, Inc. FMT Class II 1988-11-22
K883793 DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS) Yellow Springs Instrument Co., Inc. FLL Class II 1988-11-21
K883133 HANGER, INTRAVENOUS/I.V. BAG HANGER OR HOLDER Ferguson Medical FOX Class I 1988-11-21
K884620 ASD SINGLE LUMEN NEEDLE Biosurge, Inc. FMI Class II 1988-11-21
K883186 WRIGHT GRADIENT PRESSURE SUPPORT STOCKINGS Wright Linear Pump, Inc. DWL Class II 1988-11-21
K884542 SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED Commercial Products & Engineering Co. FNJ Class I 1988-11-21
K883818 MODIFIED REFLUX REDUCER Physician Engineered Products, Inc. FMS Class II 1988-11-21
K883866 NEOSOFT UMBILICAL VESSEL CATHETER Menlo Care, Inc. FOZ Class II 1988-11-21
K884160 OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM Ohmeda Medical FMT Class II 1988-11-21
K883577 BARD INFUSOR PUMP C.R. Bard, Inc. FRN Class II 1988-11-18
K884448 BLADEMATE V.I.R. Engineering, Inc. MMK Class II 1988-11-17
K884264 HIGH RISK NEEDLE CONNECTOR ASSEMBLY Venture Molded Products, Inc. FPA Class II 1988-11-14
K883779 WALLABY(TM) BLANKET Fiberoptic Medical Products, Inc. LBI Class II 1988-11-14
K884156 HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET Sechrist Industries, Inc. FPK Class II 1988-11-14
K884086 C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR Air-Shields Vickers, Inc. FMZ Class II 1988-11-14
K881866 NEEDLE REMOVER Howard, Hills & Harsh FMF Class II 1988-11-14
K884108 MACROPORE MEDICAL/SURGICAL PAPER TAPE Lectec Corp. KGX Class I 1988-11-10
K884380 BED SHEET, PILLOW CASE Saybrex Intl., Inc. KME Class I 1988-11-08
K883587 BIOSEARCH 3600 ENTRI FEEDING PUMP Biosearch Medical Products, Inc. FRN Class II 1988-11-08
K884435 RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS Clinical Connections, Inc. FMG Class II 1988-11-08
K881725 ENVIROTENT (BED) Envirotents, Inc. FNJ Class I 1988-11-08
K884295 SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE Saybrex Intl., Inc. LGM Class II 1988-11-08
K884404 HERNIASTAT Innovative Surgical Devices Corp. GAG Class II 1988-11-08
K883573 THERMOMETER, MERCURY/CLINICAL Umax Corp. FLK Class II 1988-11-07
K884370 CMS IV EXTENSION SETS Churchill Medical Systems, Inc. FPK Class II 1988-11-07
K883260 DITTMAR POWER LIFTER Dittmar and Penn Corp. FOX Class I 1988-11-07
K884341 CRITICAL CARE I.V. STAND STABILIZING BRACKET Rbd Medical, Inc. FOX Class I 1988-11-07
K884119 TYPE 9230 TEMP 1 & 2 SYSTEM ATHENA S & W Medico Teknik FLL Class II 1988-11-02
K880639 ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE Human Technologies, Inc. FLL Class II 1988-11-02
K881960 MSI STANDARD BED MODELS L1098-84/L1098-74/L1085-74 Med Service, Inc. FNL Class II 1988-11-01
K882598 250 ML BAG W/Y INJECT. & 12 EXTENSION SET Prn Services, Inc. FRN Class II 1988-11-01
K883653 EP-100 INFUSION PUMP Stereotactic Medical Systems, Inc. FRN Class II 1988-11-01
K884307 IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262 Y LDR Class II 1988-11-01
K881961 MSI STANDARD BED MODELS: L1097-64 AND L1085-64 Med Service, Inc. FNJ Class I 1988-11-01
K882949 TYMPANIC TEMPERATURE SCANNER Omega Medical Corp. FLL Class II 1988-11-01
K884259 MODIFIED LANDMARK VENOUS ACCESS DEVICE Menlo Care, Inc. FOZ Class II 1988-11-01
K883078 INSULIN SYRINGE Select Sources, Inc. FMF Class II 1988-10-31
K883033 PISTON SYRINGE WITH NEEDLE Select Sources, Inc. FMF Class II 1988-10-31
K883847 DERATA MEDI-JECTOR V Derata Corp. KZE Class II 1988-10-31
K883256 BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM Bio Clinic Co. FNM Class II 1988-10-31
K884053 PRN PLUS + INFUSION SET Prn Services, Inc. FPA Class II 1988-10-31
K883902 INFUSA-PLATE Kalajian Ent. FRN Class II 1988-10-27
K883390 PMD SYSTEM-20 Datatek, Inc. KMI Class I 1988-10-25
K881079 UVP VOLUMED 2001 Ferguson Medical FRN Class II 1988-10-25
K883802 CARETEX CENTRAL SUPPLY WRAP James River Corp. FRG Class II 1988-10-21
K883318 VALLEYLAB I.V. ADMINISTRATION SETS Valleylab, Inc. FPA Class II 1988-10-21
K883220 EXTRAVAKIT FOR RADIOLOGICAL APPLICATIONS Cancer Technologies, Inc. FMF Class II 1988-10-20
K883229 OHMEDA CONTINUOUS SUCTION REGULATOR Ohmeda Medical KDP Class II 1988-10-19
K883633 ULTRACARE Jobst Institute, Inc. DWL Class II 1988-10-18
K884212 WINGED NON-CORING NEEDLE SET Marquette Medical, Inc. FMI Class II 1988-10-17
K884211 STRAIGHT AND RIGHT ANGLE NON-CORING NEEDLES Marquette Medical, Inc. FMI Class II 1988-10-17
K883955 SINGLE-FIL(TM) SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1988-10-17
K883003 MULTI-DRUG INFUSION SYSTEM I-Flow Corp. FRN Class II 1988-10-14
K883242 EXTRAVAKIT FOR DIMETHYLSULFOXIDE (DMSO) Cancer Technologies, Inc. FMF Class II 1988-10-12
K884041 MASTER-GUARD Sparco, Inc. KCT Class II 1988-10-07
K884139 ACCI-GUARD(TM) REGULAR AND PEDIATRIC HOLDER Medical Safety Products, Inc. FMI Class II 1988-10-06
K882756 LANTOR CUBE STERILIZER TEST PACK Lantor Group JOJ Class II 1988-10-06
K883313 PMT VASCULAR CATHETER MODEL NUMBER 3621-1 Pmt Corp. LJS Class II 1988-10-04
K883009 NON-CORING NEEDLES Quinton, Inc. FMI Class II 1988-10-04
K881415 OMRON DIGITAL FEVER THERMOMETER MODEL MC-3 Omron Electronics, Inc. FLL Class II 1988-10-04
K883164 INSTAJECT II Pavel Jordan & Associates, Inc. KZH Class II 1988-10-04
K881805 TU STOPCOCK Tulan Corp. C/O Richard Hamer Assoc. FMG Class II 1988-10-04
K883415 VASCULON 2 INTRAVENOUS CANNULA Ohmeda Medical FOZ Class II 1988-10-04
K883227 SKIFA, PLASTIC DISPOSABLE SYRINGE P.T. Setio Harto , Ltd. FMF Class II 1988-09-29
K880548 SAFE-STRIPS Medstar, Inc. JOJ Class II 1988-09-29
K883612 LECTROSPIRAL Vygon Corp. FPA Class II 1988-09-29
K883376 STERILIZATION WRAP TYPE 22,44,77 East Texas Lighthouse For the Blind FRG Class II 1988-09-28
K883744 MANAN HUBER STYLE INFUSION NEEDLE Manan Medical Products, Inc. FMF Class II 1988-09-28
K882315 VIR-A-VAC EMPTY Viratec Corp. GAZ Class II 1988-09-26
K883638 SAFESITE INJECTION SITE AND BLUNT CANNULA Baxter Healthcare Corp FPA Class II 1988-09-23
K882167 IVY COMMANDER, MODEL 600 Ivy Medical, Inc. LDR Class II 1988-09-23
K882592 HEART HUGGER STERNUM SUPPORT HARNESS General Cardiac Technology, Inc. KMO Class I 1988-09-20
K882594 THE OMNI-FLOW THERAPIST INFUSION MANAGEMENT SYSTEM Omni-Flow, Inc. FRN Class II 1988-09-20
K883463 HOSPITAL BED CLOTHING CRADLE Commercial Products & Engineering Co. FNL Class II 1988-09-19

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