meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
38
Latest Decision
1992-03-18

Clearances · page 105 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K913985 TRANSFER-AID(TM) Healthtek, Inc. LHI Class II 1992-03-18
K914216 FRENTA II+ ENTERAL FEEDING PUMP Fresenius Pharma LZH Class II 1992-03-18
K914475 IV START KIT Cypress Medical Products, Ltd. LRS Class II 1992-03-18
K914864 MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR Air-Shields, Inc. FMZ Class II 1992-03-13
K915390 3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES Baxter Healthcare Corp FPA Class II 1992-03-12
K914921 SCM-3 AND ACCESSORIES Gaymar Industries, Inc. IKY Class I 1992-03-12
K915067 DISPOSABLE NEEDLE COUNTERS & DISPOSABLE SYSTEMS American Medical Corp. MMK Class II 1992-03-11
K915577 IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE Impra, Inc. CAR Class II 1992-03-11
K920059 ULTRASAFE Ultrawin Sdn Bhd LYY Class I 1992-03-11
K913876 ENDOTRACHEAL SUCTIONTUBE Willowtech JOL Class II 1992-03-06
K913896 JAIN BLOOD SHIELD Jain Surgical Equipment, Inc. JOL Class II 1992-03-06
K915499 FLO-GARD 8000 HALF-SET Baxter Healthcare Corp FRN Class II 1992-03-06
K914924 CHEMO PRIMING PIN(TM) Block Medical, Inc. FPA Class II 1992-03-06
K913931 PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF Abbott Laboratories FRN Class II 1992-03-04
K914315 OPTICAL CATHETER INTRODUCER SETS, MODIFICATION Medical Dynamics, Inc. KGX Class I 1992-03-04
K915409 INTRAOSSEOUS ACCESS NEEDLE Cook, Inc. FMI Class II 1992-03-04
K913258 DISPOSABLE INTROSSEOUS INFUSION NEEDLES Cook, Inc. FMI Class II 1992-03-04
K915565 IMMOBILE Tnt Moborg Intl. , Ltd. KGX Class I 1992-03-02
K912506 CRITIC-AID WOUND DRESSING Sween Corp. KMF Class I 1992-03-02
K915523 FLO-GARD(R) 6301 Baxter Healthcare Corp FRN Class II 1992-02-28
K915522 FLO-GARD(R) 6201 Baxter Healthcare Corp FRN Class II 1992-02-28
K915189 STERILETX POWDER FREE LATEX EXAMINATION GLOVES Transcorp LYY Class I 1992-02-27
K915303 FOIL BABY BUNTING Gam Industries, Inc. KME Class I 1992-02-20
K912444 MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM Radiometer America, Inc. LGM Class II 1992-02-18
K913696 GLOVE-CHEK PORTABLE FLUID LEAKAGE SENSING DEVICE Vertex Technical Group, Inc. LDQ 1992-02-18
K912193 3000 INFUSION PUMP Graseby Medical , Ltd. FRN Class II 1992-02-14
K912192 3100 INFUSION PUMP Graseby Medical , Ltd. FRN Class II 1992-02-14
K912771 ACACIAS PHARM/PUMP Acacia, Inc. LHI Class II 1992-02-14
K913945 STABILET INFANT RADIANT WARMER MODEL 2000C Hill-Rom, Inc. FMT Class II 1992-02-12
K915126 LATEX MED.EXAM.GLOVES POWDERED AMBIDEXTROUS Hedd Roz Canada, Inc. LYY Class I 1992-02-11
K915140 PRIMARY DRESSING TRAY Mediflex Intl. LYY Class I 1992-02-11
K913337 INJECTION CAP Cp Medical FPA Class II 1992-02-11
K915107 KEITH A-GAURD Kbk Medical Products, Inc. LYY Class I 1992-02-11
K915127 MED.EXAM.GLOVES POWDERED ANATOMICALLY CORRECT Hedd Roz Canada, Inc. LYY Class I 1992-02-11
K913804 EXCELSIOR SINGLE LEAD DISPENSING SET Excel Medical, Inc. LHI Class II 1992-02-11
K915065 I.V.IRRIGATION POLE American Medical Mfg., Inc. FOZ Class II 1992-02-11
K913888 MED-SAFE(TM) LATEX EXAMINATION GLOVES Promed Corp. LYY Class I 1992-02-07
K913958 FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP Abbott Laboratories LZH Class II 1992-02-07
K914601 SUCTION CONNECTING TUBING Bemis Mfg. Co. GCX Class II 1992-02-07
K914763 DERMACARE SYNTHETIC MEDICAL GLOVE Bd Becton Dickinson Vacutainer Systems Preanalytic LYZ Class I 1992-02-07
K914147 ALLEVLYN WOUND DRESSING, MODIFICATION Smith & Nephew United, Inc. KMF Class I 1992-02-03
K914942 PERRY(R) CUT-RESISTANT GLOVES Smith & Nephew Perry LYY Class I 1992-01-31
K914932 SUTURE REMOVAL KIT Westmark Hospital Supplies FRG Class II 1992-01-31
K915061 PROACT CLA-1500 SYSTEM Clinical Systems, Inc. FNM Class II 1992-01-31
K914927 DRESSING CHANGE KIT Westmark Hospital Supplies LYY Class I 1992-01-31
K902386 MODEL TM101 TEMPERATURE MONITOR Fisher & Paykel Electronics , Ltd. FLL Class II 1992-01-28
K920092 AUDIOTONE MODEL A97 Miracle-Ear, Inc. LYY Class I 1992-01-28
K915478 SENSICARE SYNTHETIC MEDICAL GLOVES Bd Becton Dickinson Vacutainer Systems Preanalytic LYZ Class I 1992-01-27
K914855 MULTIPLE DOSE CONTROLLER Block Medical, Inc. FRN Class II 1992-01-24
K914854 THUMPER Block Medical, Inc. FRN Class II 1992-01-24
K915231 EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS Q-Life Systems, Inc. FRN Class II 1992-01-22
K915376 GLASION VARNISH Sci-Pharm Scientific Pharmaceutical, Inc. FMC Class I 1992-01-22
K914113 ANGIOGRAPHIC FLUSH SYSTEM E-Z-Em, Inc. FPA Class II 1992-01-22
K914760 LATEX EXAMINATION GLOVES Ansell, Inc. LYY Class I 1992-01-17
K913308 IVEX-TPN EXTENSION FILTER SET Abbott Laboratories FPB Class II 1992-01-15
K914691 INDIVIDUAL/LARGE/BELT FIRST AID KITS The Lighthouse For the Blind, Inc. LYY Class I 1992-01-15
K914792 PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET Filtertek, Inc. FPA Class II 1992-01-15
K913933 TURNSOFT MATTRESS Turnsoft, Inc. FNM Class II 1992-01-10
K913386 CHEMO-PORT Hdc Corp. FMI Class II 1992-01-10
K914709 LATEX PATIENT EXAMINATION GLOVES - HYPOALLERGENIC Klh Medical, Inc. LYY Class I 1992-01-10
K905208 MORSE ANESTHESIA North American Instrument Corp. FPA Class II 1992-01-10
K913751 PRESSURE INFUSER Biomedical Dynamics, Inc. KZD Class I 1992-01-09
K914026 ANGIODYNAMICS ANGIOFILL FLUID MANAGEMENT SYSTEM E-Z-Em, Inc. FPA Class II 1992-01-09
K914543 ST5500 UNIVERSAL CARE STRETCHER Lic Care, Inc. FPO Class II 1992-01-08
K913531 PATIENT EXAMINATION GLOVEWS Pt. Sarana Indoprotex LYY Class I 1992-01-07
K914478 NSN #6545-00-656-1093 KIT, FIRST AID Cooperative Workshops, Inc. LYY Class I 1992-01-06
K913114 TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT Gerard Medical Enterprises, Inc. FMF Class II 1992-01-02
K913602 IDEAS' PORT Ideal Medical, Inc. FMF Class II 1992-01-02
K912358 LANDMARK ADD-A-LUMEN CATHETER KIT Menlo Care, Inc. FOZ Class II 1992-01-02
K913560 STOPCOCK Graham Medical Products FMG Class II 1991-12-31
K912257 CHEM-SLEEVE B Haz-Med, Inc. KME Class I 1991-12-31
K911440 RAPI-JECT(R) SYRINGE David Bull Laboratories, USA, Inc. FMF Class II 1991-12-30
K913793 SIMPEX INC. ORAL AND RECTAL THERMOMETERS Simpex, Inc. FLK Class II 1991-12-30
K914316 CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH Medi-Flex Hospital Products, Inc. LYY Class I 1991-12-24
K914284 PATIENT EXAMINATION GLOVES K-International Exports Pvt. , Ltd. LYY Class I 1991-12-23
K914349 PROVIDER APM INFUSION PUMP Abbott Laboratories FRN Class II 1991-12-19
K913661 MODIFIED VOLUMETRIC INFUSION PUMP Mcgaw, Inc. FRN Class II 1991-12-18
K914502 BARD PCA II PUMP WITH PROGRAM CARTRIDGES C.R. Bard, Inc. MEA Class II 1991-12-18
K914487 OHIO CARE PLUS INCUBATOR Ohmeda Medical FMZ Class II 1991-12-18
K912856 MEDE-FLO I.V. EXTENSION SET Medevice, Inc. FPA Class II 1991-12-17
K913694 PALCO LABS LOADMATIC Palco Laboratories, Inc. FMF Class II 1991-12-17
K912908 AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM Air-Shields Vickers, Inc. LBI Class II 1991-12-13
K913885 RINN E-Z CAPPER Rinn Corp. FMI Class II 1991-12-13
K913907 VIVUS PS (PROGRAMMING SOFTWARE) I-Flow Corp. FRN Class II 1991-12-13
K914157 DRESSING/CVP DRESSING CHANGE/HYPERALIMENT TRAYS Cml, Inc. LYY Class I 1991-12-13
K912103 LIFESHIELD EXTENSION SET Abbott Laboratories FPK Class II 1991-12-13
K912165 LANDMARK DUAL-LUMEN MIDLINE CATHETER SYSTEM Menlo Care, Inc. FOZ Class II 1991-12-11
K913082 BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D Respiratory Support Products, Inc. FLL Class II 1991-12-11
K912040 LATEX EXAMINATION GLOVES Pt. Indoraya Everlatex LYY Class I 1991-12-09
K914245 DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600) Dale Medical Products, Inc. KGX Class I 1991-12-09
K913520 EVACU SLED Nexus Health Care Products , Ltd. FPP Class I 1991-12-04
K912660 SECURODRIP Op-Co Medical Products , Ltd. KMK Class I 1991-12-04
K914912 PROMEON 63B SURGICAL TAPE Promeon KGX Class I 1991-12-04
K913413 KANGAROO(R) PET(TM) ENTERAL FEED PUMP/CHARGER BASE Sherwood Medical Co. LZH Class II 1991-11-29
K912848 I.V. FILTER EXTENSION SET Filtertek, Inc. FPB Class II 1991-11-29
K911206 MAXIMA-10 Stirn Industries FLE Class II 1991-11-29
K913608 SNAPPER Healthtek, Inc. KPE Class II 1991-11-29
K912623 MEDICAL TAPE Renfrew Tape, Ltd. KGX Class I 1991-11-27
K914498 POWDER FREE, NON-STERILE, LATEX EXAMINATION GLOVES Medmark, Inc. LYY Class I 1991-11-27
K914048 NEEDLE*LOCK(TM) WITH INTERLINK(TM) INJECTION SITE Baxter Healthcare Corp FPA Class II 1991-11-27

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