meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
33
Latest Decision
1991-04-24

Clearances · page 108 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K910673 BAG SPIGOT Procedure Products, Inc. KPE Class II 1991-04-24
K910868 TEMPERATURE WELL PROBE, TWP SERIES Gish Biomedical, Inc. FLL Class II 1991-04-22
K905849 STRATO PLASTIC PORT INTRO KT(10 FR) LPS 7523/MODIF Strato Medical Corp. LJT Class II 1991-04-19
K905840 STRATO PORT INTRODUCER KT(10 FR) LPS 5057/MODIFIED Strato Medical Corp. LJT Class II 1991-04-19
K905838 STRATO PORT INTRODUCER KT(10 FR) LPS 5015/MODIFIED Strato Medical Corp. LJT Class II 1991-04-19
K902613 BARD PCA II PUMP WITH PROGRAM CARTRIDGES C.R. Bard, Inc. FRN Class II 1991-04-19
K910377 COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM CooperSurgical, Inc. GCX Class II 1991-04-19
K910486 8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER Davol, Inc. LJS Class II 1991-04-19
K905850 STRATO PLASTIC PORT INTRO(9 FR)LPS 7513/MODIFIED Strato Medical Corp. LJT Class II 1991-04-19
K905841 STRATO PORT INTRODUCER KT(12 FR) LPS 5200/MODIFIED Strato Medical Corp. LJT Class II 1991-04-19
K905839 STRATO PORT INTRODUCER KT(10 FR) LPS 5013/MODIFIED Strato Medical Corp. LJT Class II 1991-04-19
K905852 STRATO PLAST PORT INTRO KT(10 FR)LPS 7013/MODIFIED Strato Medical Corp. LJT Class II 1991-04-19
K905843 STRATO PLAST INTRODUCER KIT(12 FR) LPS 7113/MODIF Strato Medical Corp. LJT Class II 1991-04-19
K905845 STRATO PORT INTRODUCER KT(9 FR) LPS 5513/MODIFIED Strato Medical Corp. LJT Class II 1991-04-19
K905842 STRATO PORT INTRODUCER KT(12 FR) LPS 5213/MODIFIED Strato Medical Corp. LJT Class II 1991-04-19
K911055 A-PORT IMPLANT VASC ACCESS SYST LINE EXT-A2 PORT Therex Corp. LJT Class II 1991-04-19
K911146 TAN CHONG GLOVE, HYPOALLERGENIC Boston Medical Corp. LYY Class I 1991-04-18
K905498 STAT 2 IV PUMPETTE The Master Medical Corp. LDR Class II 1991-04-16
K910213 NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION Abbott Laboratories LHI Class II 1991-04-16
K910520 SAFETYSNAP SAFETY SYRINGE U.S. Medical Instruments, Inc. FMF Class II 1991-04-16
K911447 LATEX EXAMINATION GLOVES (HYPOALLERGENIC) Aladan Corp. LYY Class I 1991-04-16
K905497 MASTER FLOW I.V. PUMPETTE The Master Medical Corp. LDR Class II 1991-04-16
K911355 LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015 Strato Medical Corp. LJT Class II 1991-04-15
K905693 H-TRON V 100 INSULIN INFUSION PUMP Disetronic Medical Systems LZG Class II 1991-04-12
K910977 LANEX EXAM GLOVES Multi M Intl., Inc. LYY Class I 1991-04-12
K910718 YSI PRECISION 4000 THERMOMETER Yellow Springs Instrument Co., Inc. FLL Class II 1991-04-09
K905846 STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION Strato Medical Corp. LJT Class II 1991-04-08
K910218 LAPAROMED CHOLANGIOGRAM VACUUM DEVICE Laparomed Corp. GCX Class II 1991-04-08
K905848 LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI Strato Medical Corp. LJT Class II 1991-04-08
K910428 EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS Baxter Healthcare Corp FRN Class II 1991-04-08
K910315 PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K Sorex Medical LJS Class II 1991-04-05
K905851 STRATO PLAST W/PRE-ATTACH CATH(LPS 6015)/MODIFIED Strato Medical Corp. LJT Class II 1991-04-05
K905847 STRATO LIFE PORT II DUAL LUMEN PORT/MODIFICATION Strato Medical Corp. LJT Class II 1991-04-05
K905844 STRATO STAND METAL PORTS (LPS 1013/1015)/MODIFIED Strato Medical Corp. LJT Class II 1991-04-03
K910425 LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH. Baxter Healthcare Corp FRN Class II 1991-04-01
K905586 RSVP RF-2000 Tactilitics, Inc. KMI Class I 1991-04-01
K910709 WEEVAC TC HAND CARRIED RESCUE STRETCHER W. Murphy Ent., Inc. FPP Class I 1991-04-01
K910906 CENTURION KLEEN-NEEDLE SYSTEM I.V. EXTENSION SETS Tri-State Hospital Supply Corp. FPK Class II 1991-04-01
K910622 GESCO PER-Q-CATH REPAIR KIT Gesco Intl., Inc. LJS Class II 1991-03-29
K910363 MEGA DRESSING CHANGE KIT Megadyne Medical Products, Inc. MCY Class II 1991-03-28
K905448 THORA-KLEX CHEST DRAINAGE UNIT Davol, Inc. GCX Class II 1991-03-27
K905646 OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY Norfolk Medical LJT Class II 1991-03-27
K910011 POST SURGICAL KIT/POST BIOPSY KIT Dermatological Research Laboratories, Inc. MCY Class II 1991-03-27
K901157 MP4, MP4SI, IT4 INCUBATORS Mediprema FMZ Class II 1991-03-27
K905123 G-TUBE DRESSING CHANGE TRAY Continental Medical Laboratories, Inc. MCY Class II 1991-03-27
K901763 NATURE'S CRADLE(TM) Infant Advantage, Inc. FMS Class II 1991-03-22
K905384 DAVID SIMMONDS ANESTHESIA EXTENSION TUBES Sparta Surgical Corp. FMF Class II 1991-03-22
K905527 NEEDLESTICK PROTECTIVE GLOVE Medev Corp. LZC Class I 1991-03-22
K910799 LANDMARK VENOUS ACCESS DEVICE Menlo Care, Inc. FOZ Class II 1991-03-21
K910793 RECONSTITUTION DEVICE Baxter Healthcare Corp LHI Class II 1991-03-21
K910581 U.S. MEDICAL PS-1000 PEDIATRIC SCALE U.S. Medical Corp. FRW Class I 1991-03-21
K910582 U.S. MEDICAL PS-2000 PEDIATRIC SCALE U.S. Medical Corp. FRW Class I 1991-03-21
K910523 MODIFIED VOLUMETRIC INFUSION PUMPS ATTACHMENTS Baxter Healthcare Corp FRN Class II 1991-03-21
K910695 AUTO SASH (TM) Block Medical, Inc. FPA Class II 1991-03-21
K911081 LATEX PATIENT EXAMINATION GLOVES Medical Device Inspection Co., Inc. LYY Class I 1991-03-21
K910583 U.S. MEDICAL PS-3000 NEONATAL SCALE U.S. Medical Corp. FRW Class I 1991-03-21
K904904 MEDICOPASTE BANDAGE WITH CALAMINE/MODIFICATION Graham-Field, Inc. KGX Class I 1991-03-19
K910436 ELASTIC ADHESIVE BANDAGE Byron Medical KGX Class I 1991-03-19
K904620 STERAID DISPOSABLE SYRINGE Disposable Medi-Aids , Ltd. FMF Class II 1991-03-15
K905664 VIAL ACCESS CANNULA Baxter Healthcare Corp FMI Class II 1991-03-15
K905122 SENTRY SCALE Apollo Enterprise, Ltd. Co. FRW Class I 1991-03-15
K905062 INJECTOR, INSULIN Sound 2000 Medical Systems, Inc. KZE Class II 1991-03-15
K905629 PEDICRAFT INFANT REFLUX WEDGE Pedicraft, Inc. FRP Class I 1991-03-13
K910202 DENTRONIX MODEL 2000 Dentronix, Inc. KMH Class II 1991-03-13
K905630 INFANT REFLUX SLING Pedicraft, Inc. FRP Class I 1991-03-13
K910335 MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA Medical Technical Products FRN Class II 1991-03-13
K910005 VITAL-PORT(TM) M.R.I. VASCULAR ACCESS SYSTEM Med Institute, Inc. LJT Class II 1991-03-13
K905381 MANHANDLER Lifeport, Inc. FPP Class I 1991-03-13
K905572 EDLICH WOUND MANAGEMENT TRAY Sorex Medical MCY Class II 1991-03-12
K910891 PVC VINYL GLOVE Pioneer Sundries Products , Ltd. LYZ Class I 1991-03-11
K910471 MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE Baxter Healthcare Corp GAZ Class II 1991-03-08
K905755 NON-STERILE PATIENT EXAMINATION GLOVES Superior Healthcare Group, Inc. LYY Class I 1991-03-08
K905696 STRATOFUSE PCA INFUSER Strato Medical Corp. FRN Class II 1991-03-08
K904697 PATIENT EXAMINATION GLOVES Shamrock Marketing Co. LYY Class I 1991-03-08
K910417 EVIDENCE BIOLOGICAL INDICATOR Skyland Scientific Services, Inc. FRC Class II 1991-03-08
K910660 BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC Boston Medical Corp. LYY Class I 1991-03-07
K910631 SUNTEX STERILE EXAM GLOVES P.T. Latexindo Prautama LYY Class I 1991-03-07
K901146 JOSLYN EO STERILIZER/ EO MODERNIZATION KIT Joslyn Valve Corp. FLF Class II 1991-03-07
K910775 JM GLOVES STERILE VINYL EXAMINATION Jm Gloves Co., Ltd. LYZ Class I 1991-03-07
K905631 COMPRINET, COMTESSE AND BELLAVAR STOCKINGS Jobst Institute, Inc. DWL Class II 1991-03-07
K910774 AM GLOVES STERILE VINYL EXAMINATION Am Gloves Co., Ltd. LYZ Class I 1991-03-07
K903648 VYGON LIFEVAC PICC Vygon Corp. LJS Class II 1991-03-07
K904445 OMIBAND Omikron Scientific, Ltd. KGX Class I 1991-03-06
K905414 MANGAR BOOSTER Northfleet Management Group, Inc. FNG Class II 1991-03-05
K905610 MICRORATE INTELLIGENT PUMP Kendall Mcgaw Laboratories, Inc. FRN Class II 1991-03-01
K905611 MICRORATE PLUS INTELLIGENT PUMP Kendall Mcgaw Laboratories, Inc. FRN Class II 1991-03-01
K905765 PILGRIM NITRILE LATEX GLOVES (VARIOUS TYPES) Tillotson Rubber Co., Inc. LYY Class I 1991-02-25
K910439 FOXELL PLUS MULTIPLE (PERSONAL TOUCH TM) Lowenkamp Intl., Inc. LYY Class I 1991-02-25
K910542 DIGIFLEX, LATEX PATIENT EXAMINATION GLOVES 21st Century Group LYY Class I 1991-02-19
K910455 IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR Ziehm International, Inc. FMI Class II 1991-02-14
K905652 MYOCARDIAL TEMPERATURE MONITORING PROBES, CJ-1000 Daily Medical Products, Inc. FLL Class II 1991-02-14
K910118 DATA RECORDER Healthdyne, Inc. FLL Class II 1991-02-14
K910442 PATIENT EXAMINATION GLOVES Asian Latex, Ltd. LYY Class I 1991-02-12
K905061 APOLLO MOBILE SCALE Apollo Enterprise, Ltd. Co. FRW Class I 1991-02-12
K905421 EXIT ALARM Alertcare KMI Class I 1991-02-12
K904839 PATIENT EXAM GLOVES(MFG: YUNG CHIEH ENTERPRISE) Up TO Date, Inc. LYY Class I 1991-02-12
K905305 SAFE-SITE NEEDLE COVER North American Medical Products, Inc. FMI Class II 1991-02-12
K904558 DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL Davol, Inc. FOZ Class II 1991-02-11
K905022 AQUA-GARD WATERPROOF WOUND PATCH Bellhouse Medical, Inc. KGX Class I 1991-02-11
K905768 PLEUR-EVAC CHEST DRAINAGE SYSTEMS Deknatel, Inc. KDQ Class II 1991-02-11

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