meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
35
Latest Decision
1991-11-27

Clearances · page 106 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K913498 MX927 BLOOD TRANSFER DEVICE Medex, Inc. FMI Class II 1991-11-27
K914134 INCUBATOR 8000 SC National Draeger, Inc. FMZ Class II 1991-11-22
K913394 INCUBATOR 8000 IC Dragerwerk AG FMZ Class II 1991-11-22
K911893 EASY ACCESS BED Willis Therapeutic Innovations, Inc. FNL Class II 1991-11-22
K911782 PUMPMAN(TM) AMBULATORY DRUG DELIVERY SYSTEM Strato Medical Corp. FRN Class II 1991-11-22
K910448 SNAP-LOCK MICRO PORT, MODIFICATION Infusaid Corp. LJT Class II 1991-11-21
K911939 SAS RUBBER PRODUCTS CO./LATEX EXAMINATION GLOVES Overseas Import & Export Dist. LYY Class I 1991-11-15
K913291 MODEL C386 ISOLETTE(R) INFANT INCUBATOR Air-Shields, Inc. FMZ Class II 1991-11-13
K911103 DANBY D.S.P. SYRINGE PUMP Isys Medical , Ltd. FRN Class II 1991-11-08
K913776 PATIENT EXAMINATION GLOVES P.T. Irama Dinamika Latex LYY Class I 1991-11-07
K914628 PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF Medical Resources, Ltd. LYY Class I 1991-11-07
K910257 BAXA PCA INFUSOR Baxa Corp., Sub. of Cook Group, Inc. MEA Class II 1991-11-07
K904619 INFU.DISK Electrochemical Drug Delivery, Inc. FRN Class II 1991-11-05
K912909 SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM Air-Shields Vickers, Inc. FMZ Class II 1991-11-05
K911865 NORTEC CONNECTING TUBE SET North American Sterilization & Packaging Co. GAZ Class II 1991-11-01
K913568 SURGI-SPRAY O.R. IRRIGATION SYSTEM Phoenix Surgical Products, Inc. FQH Class II 1991-11-01
K913317 MEGA ARTHROGRAM KIT Mega Medical, Inc. FMI Class II 1991-10-31
K913235 DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH Davol, Inc. FMF Class II 1991-10-31
K913720 PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED Abbott Laboratories FRN Class II 1991-10-30
K912910 C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM Air-Shields Vickers, Inc. FMZ Class II 1991-10-30
K913718 PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED Abbott Laboratories FRN Class II 1991-10-30
K913719 PANCRETEC I.V. MODEL 5500 INFUSER Abbott Laboratories FRN Class II 1991-10-30
K914034 INFUCARE SYRINGE PUMP TUBING SET Infucare Products, Inc. FRN Class II 1991-10-30
K911251 FLEX-IV Medway FOZ Class II 1991-10-28
K914094 DERMASAFE(TH) HYPOALLERGENIC Multi-Com Sdn Bhd LYY Class I 1991-10-28
K910778 STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS) Mdt Biologic Co. FLE Class II 1991-10-28
K914314 FORTEX(TM) WOUND DRESSING Calgon Vestal Div. KMF Class I 1991-10-23
K912158 CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY Medical Device Inspection Co., Inc. FOZ Class II 1991-10-23
K913333 I.V. PRIMING SET Gainor Medical Europe, Ltd. FPA Class II 1991-10-23
K914049 MULTIPLE LATEX PATIENT EXAMINATION GLOVES London Rubber Co. (India) , Ltd. LYY Class I 1991-10-23
K913895 FLO-GARD(R) 6200, 6300 & 8000 Baxter Healthcare Corp FRN Class II 1991-10-21
K914074 8000 SERIES VOLUMETRIC PUMP SOLUTION SET Baxter Healthcare Corp FPA Class II 1991-10-21
K912116 PRESSURE SORE MANAGEMENT KIT Medical Device Inspection Co., Inc. MCY Class II 1991-10-18
K913480 WOUND CARE TRAY A Catalina Biomedical Corp. MCY Class II 1991-10-18
K913076 I.V. INSTANT TIMER The Master Medical Corp. FPA Class II 1991-10-17
K910693 PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET Baxter Healthcare Corp JOL Class II 1991-10-17
K912590 AVI MODEL 400D INFUSION PUMP 3M Avi, Inc. FRN Class II 1991-10-17
K912280 BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D Respiratory Support Products, Inc. FLL Class II 1991-10-17
K913141 MEGA MYELOGRAM KIT Megadyne Medical Products, Inc. FMI Class II 1991-10-17
K913083 BI-TEMP TEMPERATURE MONITOR TM-201D Respiratory Support Products, Inc. FLL Class II 1991-10-17
K911383 HOTLINE FLUID WARMER Level 1 Technologies, Inc. LGZ Class II 1991-10-17
K912589 AVI MODEL 840D DUAL CHANNEL INFUSION PUMP 3M Avi, Inc. FRN Class II 1991-10-17
K912684 HOME MEDICAL KIT - FOR LITTLE HURTS Great West Medical Equipment, Inc. MCY Class II 1991-10-15
K912330 B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204 Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1991-10-11
K913643 MUCOUS SPECIMEN TRAP Medical Device Inspection Co., Inc. BYZ Class II 1991-10-10
K914081 ICAN COTTON RAYON BALLS Icn Pharmaceuticals, Inc. FRL Class I 1991-10-09
K912160 BUTTERFLY DRESSING Durden Enterprises, Inc. KGX Class I 1991-10-09
K902401 CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM Burron Medical, Inc. FMF Class II 1991-10-08
K913914 PROGUARDII(TM) BLOOD COLLECTION DEVICE Care Medical Devices, Inc. FMI Class II 1991-10-08
K913479 WOUND CARE TRAY B Catalina Biomedical Corp. MCY Class II 1991-10-08
K912111 MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE Gerard Medical Enterprises, Inc. FMF Class II 1991-10-08
K910323 BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000) Uab Research Foundation FLN Class II 1991-10-03
K912563 ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SE Mbo Laboratories, Inc. FOZ Class II 1991-10-02
K912769 PATIENT LIFT AND TRANSPORT Century Manufacturing Co. FNG Class II 1991-10-02
K913409 LATEX EXAMINATION GLOVES Top Glove Sdn. Bhd. LYY Class I 1991-09-27
K912975 OPERAND LUBRICATING JELLY General Medical Co. KMJ Class I 1991-09-27
K912942 IV HOUSE Progressive Iv'S, Inc. KMK Class I 1991-09-25
K913902 B-D(R) HYPOALLERGENIIC NON-STERILE PAT EXAM GLOVES Bd Becton Dickinson Vacutainer Systems Preanalytic LYZ Class I 1991-09-25
K912861 FLU ADMIN/WASTE DISP SYS/PROTEC STA/ADMIN/FLUSH-N- Biocor, Inc. FPA Class II 1991-09-24
K912392 PROBE LATEX EXAMINATION GLOVES - STERILE Glovetex Industries LYY Class I 1991-09-23
K913279 LATEX EXAMINATION GLOVES Liwe Trading LYY Class I 1991-09-23
K913627 3 PORT ADAPTER Baxter Healthcare Corp FPA Class II 1991-09-23
K912753 XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL Xomed-Treace, Inc. GCX Class II 1991-09-23
K913048 SIME TRUFEEL Sime Health, Ltd. LYY Class I 1991-09-19
K912702 PLASTIC ATTACHABLE DUAL PORT Davol, Inc. LJT Class II 1991-09-18
K913018 MED-E-JET INJECTOR Med-E-Jet D KZE Class II 1991-09-16
K913311 SAFETY INJECTION PORT, MODIFICATION Riverside Technology, Inc. FPA Class II 1991-09-13
K913446 ICAN NEEDLE COUNTERS Icn Pharmaceuticals, Inc. MMK Class II 1991-09-13
K913154 OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION Ohmeda Medical FMZ Class II 1991-09-13
K911079 AMB-ALERT Medway KMI Class I 1991-09-13
K912141 VOLUMETRIC PUMP SOLUTION SET MODIFIED CASSETTE Baxter Healthcare Corp FPA Class II 1991-09-11
K904924 INFUSA PU SYRINGE INFUSION PUMP Ferguson Medical FRN Class II 1991-09-10
K912591 AVI MICRO 210D INFUSION PUMP 3M Avi, Inc. FRN Class II 1991-09-06
K913056 VOLUMETRIC INFUSION PUMP, MODIFICATION Mcgaw, Inc. FRN Class II 1991-09-06
K912503 HYPOALLERGENIC EXAMINATION LATEX GLOVES Medigloves , Ltd. LYY Class I 1991-09-06
K910159 WINGED ADMININ. SET W/NON-CORING NEEDLE Dmd Products FPA Class II 1991-09-06
K911128 MEDIZIV INFUSION SET Medicia Medical Products FPA Class II 1991-09-06
K910649 MDT/CASTLE 10/90 LOAD STATION Mdt Biologic Co. FLF Class II 1991-09-06
K904923 INFUSA T SYRINGE INFUSION PUMP Ferguson Medical FRN Class II 1991-09-06
K912518 CIRCULON(TM) ADHESIVE COMPRESSION BANDAGE Convatec, A Division of E.R. Squibb & Sons KGX Class I 1991-09-04
K910667 STERI-STAT REUSABLE SYRINGE David Craig Marketing, Inc. FMI Class II 1991-09-04
K904925 INFUSA TS SYRINGE INFUSION PUMP Ferguson Medical FRN Class II 1991-09-04
K904922 INFUSA D.SLT SYRINGE INFUSION PUMP Ferguson Medical FRN Class II 1991-09-04
K912860 INTRAVASCULAR ADMINISTRATION SETS Pacific Device, Inc. FPA Class II 1991-08-28
K912704 ATRIUM 2000 CHEST DRAIN Atrium Medical Corp. KDQ Class II 1991-08-26
K911322 MODEL #M9 ULTRACLAVE STEAM STERILIZER Midmark Corp. FLE Class II 1991-08-26
K910789 KAVOKLAVE STEAM AUTOCLAVE Kavo America FLE Class II 1991-08-26
K912824 DEVON SPONGE COUNTER BAGS Devon Industries, Inc. LWH Class I 1991-08-26
K912928 LIFECARE 4100 PCA INFUSER PLUS II Abbott Laboratories FRN Class II 1991-08-26
K913329 V-ACCI-GUARD(TM) REUSABLE HOLDER Medical Safety Products, Inc. FMI Class II 1991-08-23
K912540 CONTOUR-PORT Ideal Medical, Inc. LJT Class II 1991-08-23
K912914 DANBY-DCR VOLUMETRIC INFUSION PUMP Danby Medical , Ltd. FRN Class II 1991-08-22
K912875 AVI MODEL 270CI INFUSION PUMP 3M Avi, Inc. FRN Class II 1991-08-20
K912010 I.V. SKY-HOOK Dina - Industria, Comercio E Exportacao , Ltd. FOX Class I 1991-08-19
K912650 1.1, 1.2, 1.3 TEMPERATURE PROBES Vital Signs, Inc. FLL Class II 1991-08-16
K912550 DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED Convatec, A Division of E.R. Squibb & Sons KGX Class I 1991-08-14
K912232 ULCERCARE Jobst Institute, Inc. MCY Class II 1991-08-14
K912999 DENTA SAFE(TM) LATEX EXAMINATION GLOVES Dental Care Intl., Inc. LYY Class I 1991-08-13
K912765 STASIS BUTTON PRSSURE DEVICE Arch Development Group MHW Class I 1991-08-12
K912738 AVI VOLUMETRIC INFUSION PUMPS-VARIOUS MODELS 3M Avi, Inc. FRN Class II 1991-08-12

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