meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
44
Latest Decision
1981-11-06

Clearances · page 148 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K812934 MONOJECT PREFILLED SYRINGES Sherwood Medical Co. FMF Class II 1981-11-06
K810850 PERSONAL MEDICATION INFUSER Pacesetter Systems FRN Class II 1981-11-06
K812917 PORTABLE LIDOCAINE INFUSION PUMP Cardiac Pacemakers, Inc. FRN Class II 1981-11-06
K812745 WARMING LISTHTS #96H & 96HT J. H. Emerson Co. FMT Class II 1981-11-02
K812874 PEDIATRIC MICROAGGREGATE BLOOD FILTER Abbott Laboratories CAK Class II 1981-11-02
K812852 SET FOR ASEPTIC DECANTING OF A FLEX I.V Dip, Inc. KPE Class II 1981-11-02
K812867 STERI-VAC #400C GAS STERILIZER 3M Company FLF Class II 1981-11-02
K812824 PRESSURE DISC COMPONENT FOR ACCUSET Imed Corp. FRN Class II 1981-10-27
K812823 IMED MODEL 970 & 975 VOL. INFUSION PUMP Imed Corp. FRN Class II 1981-10-27
K812746 THORACIC DRAINAGE SET #55-DB2-G J. H. Emerson Co. KDQ Class II 1981-10-26
K812748 MONOJECT M535 35CC SYRINGE Sherwood Medical Co. FMF Class II 1981-10-23
K812657 INJECTION CAP, LUER LOCK Procedure Products, Inc. FPA Class II 1981-10-23
K812683 NEONATE FLEXFLOAT Pharmaquest Corp. FOH Class I 1981-10-13
K812560 MDM ARTERIAL BLOOD GAS SYRINGE Martell Medical Products, Inc. FMF Class II 1981-10-09
K812697 HEMA 20 MICRON TRANSFUSION BLOOD FILTER Abbott Laboratories CAK Class II 1981-10-08
K812682 FLEXFLOAT HEATER Pharmaquest Corp. FOH Class I 1981-10-08
K812684 ADULT FLEXFLOAT Pharmaquest Corp. FOH Class I 1981-10-08
K812656 DOTRICH ELECTRONIC AIR CLEANER #C500AM Leedal, Inc. FRF Class II 1981-10-08
K812681 ADULT FLEX FLOAT W/HEATER Pharmaquest Corp. FOH Class I 1981-10-08
K812073 DESERET CATHETER DRESSING Warner-Lambert Co. KGX Class I 1981-10-06
K812688 QI 1150-1T INFUSION T Quinton, Inc. FPA Class II 1981-10-02
K812297 A.D.T. PROCEDURES TRAY A.D.T. Lab Industries KMJ Class I 1981-09-28
K812482 FOAM WEDGE Maddak, Inc. LDQ 1981-09-24
K812600 GER 540, GER 541 MANUAL BED G.W. Healthcare, Inc. FNJ Class I 1981-09-23
K812457 HIFLO-HP Tri-Med, Inc. FPB Class II 1981-09-21
K812499 INFUSION PUMP Nu Tech Medical Systems FRN Class II 1981-09-16
K812510 TRAVENOL INFUSION CONTROLLER 2M8052 Travenol Laboratories, S.A. LDR Class II 1981-09-16
K812442 3M INFUSION SYSTEM 3M Company FRN Class II 1981-09-16
K812527 IVA SEAL II U.S. Clinical Products, Inc. KPE Class II 1981-09-16
K811783 ENDOPUMP Medtron Development , Ltd. FRN Class II 1981-09-11
K812344 HEEL OR ELBOW PROTECTOR Fred Sammons, Inc. FMP Class I 1981-09-11
K812224 PLEURAL DRAINAGE SYSTEM #PDS-4300 Bentley Laboratories, Inc. KDQ Class II 1981-09-09
K812339 TERUFUSION INFUSION PUMP MODEL STC-502 Terumo Medical Corp. FRN Class II 1981-09-09
K812404 BUTTERFLY NEEDLE ASSEMBLY Nu Tech Medical Systems FMI Class II 1981-09-09
K812387 DIGITRON ELECTRONIC THERMOMETERS - 4700 Ercona Corp. FLL Class II 1981-09-09
K812272 CASTLE TEC-TEST BIOLOGICAL INDICATOR Sybron Corp. FRC Class II 1981-09-08
K812159 INTRAVASCULAR CATHETER Pioneer Viggo, Inc. FOZ Class II 1981-08-31
K812233 RATEMINDER Anatros Corp. LDR Class II 1981-08-25
K811885 30-30-2 700 SYRINGE EXTENSION SET Y FPA Class II 1981-08-25
K811365 HILL TOP CHAMBER Hill Top Research, Inc. KXF Class I 1981-08-20
K812114 LIFECARE 1000 CONTROLLER Abbott Laboratories LDR Class II 1981-08-20
K812216 CUDDLE CAP Darcy, Inc. LDQ 1981-08-20
K812231 INTRAVENOUS ADMINISTRATION SET Cordis Corp. FPA Class II 1981-08-20
K812139 VACUUM SUCTION FILTER K & G Healthcare Ind., Inc. KDQ Class II 1981-08-20
K811997 SHARPS SAFE Instra-Metics, Inc. MMK Class II 1981-08-18
K811437 MODIFIED THORACENTESIS CATHETER Blair Medical Products KDQ Class II 1981-08-13
K812142 LIC 180 MEDICAL LAMPS Lada Intl., Inc. KZF Class I 1981-08-13
K812079 DISPOSABLE PILLOW Carpenter Co. KME Class I 1981-08-04
K811819 BOUNDARY STERILIZATION WRAP The Buckeye Cellulose Corp. FRG Class II 1981-08-04
K811955 CALIBRATED BREATHING SYSTEM COLLECTION Anchor Brush Co., Inc. KDQ Class II 1981-08-04
K812080 AEGIS I.V. STRIPS Warner-Lambert Co. KMK Class I 1981-08-03
K811914 FLU VEN I.V. SETS Venusa , Ltd. FPA Class II 1981-08-03
K811364 AXICARE BREAST SHELL Neonatal Corp. HFS Class I 1981-08-03
K812021 VOLUMETRIC INFUSION PUMP American Edwards Laboratories FRN Class II 1981-07-31
K812042 INFUSION PUMP MODEL 200/201 Medix Medical Electronics (U.S.A.), Inc. FRN Class II 1981-07-31
K811900 CENTURY SAF-LIFT & SAF-KARY Century Manufacturing Co. FNG Class II 1981-07-28
K811897 LIC TURNOVER BED Century Manufacturing Co. FNL Class II 1981-07-28
K812035 IMED ACCUSET CASSETTE Imed Corp. FRN Class II 1981-07-28
K812037 TEMPERATURE MONITOR 130/131/133 Medix Medical Electronics (U.S.A.), Inc. FLL Class II 1981-07-28
K811985 ULTIPOR SQ40S BLOOD TRANSFUSION FILTER Pall Biomedical Products Co. CAK Class II 1981-07-28
K812023 MONOJECT STERILE M506 6CC SYRINGES Sherwood Medical Co. FMF Class II 1981-07-28
K811915 MONITOR/VITAL SIGNS TRAY American Hospital Supply Corp. FME Class I 1981-07-28
K811936 CHEMICAL AUTOCLAVE INDICATOR TAPE American Hospital Supply Corp. JOJ Class II 1981-07-28
K811990 TRACH CLEANING TRAY Associated Medical Products Co. FRL Class I 1981-07-27
K811901 CENTURY BATHING SYSTEM Century Manufacturing Co. FNG Class II 1981-07-23
K811966 VISITEC NEEDLE RANGE (GENERAL HOSPITAL) Visitec Co. FMI Class II 1981-07-23
K811899 CENTURY LIFT TRANSFER SYSTEM Century Manufacturing Co. FSA Class I 1981-07-23
K811917 I.V. ADMIN. SETS FOR THE AMP MARK IV PMP American Medical Products, Inc. FRN Class II 1981-07-23
K811918 AMP MARK IV INFUSION PUMP American Medical Products, Inc. FRN Class II 1981-07-20
K811884 IVAC 700 SYRINGE INFUSION PUMP Y FRN Class II 1981-07-20
K811933 GUARDIAN, VOLUMETRIC CONTROL DELIVERY Avi, Inc. FRN Class II 1981-07-20
K811631 THERMOMETER (MADE IN CHINA) Robert I. Chien & Assoc., Inc. FLK Class II 1981-07-20
K811773 BACTAGARD Tri-Med, Inc. FPB Class II 1981-07-13
K811847 SEA MEDICAL PRODUCTS LO-VOL Sea Medical Products, Inc. FPK Class II 1981-07-13
K811432 MILLIPORE DUAL RATE INTRAVENOUS CASSETTE Millipore Corp. LDR Class II 1981-07-13
K811670 STERI-LOK DUAL PURPOSE PACKAGING/8400 3M Company FRG Class II 1981-07-10
K811625 PREP-SITE PROTECTIVE DRESSING WIPE Acme United Corp. KMF Class I 1981-07-10
K811774 OPEN LOOP AMBULATORY INFUSION DEVICE Cardiac Pacemakers, Inc. FRN Class II 1981-07-10
K811724 2M 9810 MICROWAVE OVEN Travenol Laboratories, S.A. LHF Class II 1981-07-10
K811726 LEKSELL STEREOACTIC SYSTEM Downs Surgical , Ltd. LHF Class II 1981-07-10
K811837 I.V. ADMINISTRATION SET Medisystems Corp. FPA Class II 1981-07-10
K811272 RAZEL MODEL C Razel Scientific Instruments, Inc. FRN Class II 1981-07-10
K811739 ENTRI ENTERAL FEEDING PUMP Biosearch Medical Products, Inc. FRN Class II 1981-07-10
K811424 ELECTRONIC APGAR TIMER Pt&E LHB Class I 1981-07-09
K811397 ECA Gillco, Inc. FOA Class I 1981-07-02
K811684 AMERICAN AIRCARE SYSTEM American Hamilton FNM Class II 1981-07-02
K811078 RADIATION STERILIZED ADMIN. SET Travenol Laboratories, S.A. FPA Class II 1981-07-02
K811685 I.V. ADMINISTRATION SET Quest Medical, Inc. FPA Class II 1981-06-30
K810761 ALPHA MICRON-40 FILTER Alpha Therapeutic Corp. CAK Class II 1981-06-30
K811561 LO-VOL I.V. SETS Sea Medical Products, Inc. FPA Class II 1981-06-26
K811672 NORELCO ELECTRONIC DIGITAL THERMOMETER North American Philips Corp. FLL Class II 1981-06-26
K810614 CASTLE STEAM STERILIZATION INDICATOR Sybron Corp. JOJ Class II 1981-06-24
K811268 BOTTLE-TO-BOTTLE Medi-Plast Intl., Inc. KPE Class II 1981-06-18
K811505 MONOJECT STERILE M503 3CC SYRINGES Sherwood Medical Co. FMF Class II 1981-06-18
K811541 MGN CONNECTING TUBE Mgn Medical Manufacturing, Inc. BYY Class II 1981-06-18
K811547 MATELAS COQUILLE LATTREDE TASSIGNY Firn-France FPP Class I 1981-06-18
K811173 STRUVA & MEDI Weco FQM Class I 1981-06-18
K811234 I.V. BOTTLE (RIDGID) Medi-Plast Intl., Inc. KPE Class II 1981-06-18
K811233 I.V. PLASTIC BAG Medi-Plast Intl., Inc. KPE Class II 1981-06-17
K810930 BACILLUM PUMILUS SPORE STRIPS Oxoid U.S.A., Inc. FRC Class II 1981-06-16

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