meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
38
Latest Decision
1990-08-30

Clearances · page 111 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K903193 SMITH & NEPHEW DYONICS LEVELERT SYSTEM Smith & Nephew Dyonics, Inc. FLN Class II 1990-08-30
K903784 AVI MODEL 480CM INFUSION PUMP 3M Avi, Inc. FRN Class II 1990-08-30
K903781 AVI MODEL 880 DUAL CHANNEL INFUSION PUMP 3M Avi, Inc. FRN Class II 1990-08-30
K902624 BD FLEXIBLE DIGITAL THERMOMETER Bd Becton Dickinson Vacutainer Systems Preanalytic FLL Class II 1990-08-30
K902770 PATIENT EXAMINATION GLOVE Mastri Lieno, PT LYY Class I 1990-08-29
K903107 PATIENT EXAM GLOVES (DUSTED W/USP STARCH POWDER) Ansell, Inc. LYY Class I 1990-08-29
K902854 GRAVITY ASSIST Instrument Makar, Inc. KYZ Class I 1990-08-29
K901755 MODEL 3001 SYRINGE INFUSION PUMP Medfusion, Inc. FRN Class II 1990-08-29
K903108 PATIENT EXAM GLOVES (FINISH W/USP STARCH POWDER) Ansell, Inc. LYY Class I 1990-08-29
K902278 PVC PATIENT EXAMINATION GLOVE Fujian Province Jiu Zhou Group FMC Class I 1990-08-29
K900468 LIFECARE(R) MODEL 3 PUMP Abbott Laboratories FRN Class II 1990-08-27
K900467 LIFECARE MODEL 4 PUMP Abbott Laboratories FRN Class II 1990-08-27
K903350 PROLAX DISPOSABLE LATEX GLOVES (EXAM) HYPOALLERGEN Prolax Medical Products, Inc. LYY Class I 1990-08-23
K903352 PROLAX DISPOSABLE LATEX GLOVES (EXAMINATION) Prolax Medical Products, Inc. LYY Class I 1990-08-23
K901225 LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR) Abbott Laboratories KZD Class I 1990-08-23
K901263 NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM Navion Biomedical Corp. FOZ Class II 1990-08-22
K895910 STEAMLINE Propper Mfg. Co., Inc. JOJ Class II 1990-08-22
K895922 METRICARE EMPTY CONTAINER SYSTEMS Metrix Co. LHI Class II 1990-08-22
K896075 CADD-PCA AMBULATORY INFUSION PUMPS Pharmacia Deltec, Inc. FRN Class II 1990-08-21
K903656 PATIENT EXAMINATION GLOVES United Rubber Corp. (Sabah) Sdn. Bhd. LYY Class I 1990-08-21
K901237 GLOVE LEAK DETECTOR Utah Medical Products, Inc. LDQ 1990-08-21
K901096 LUMISCOPE ALTERNATING PRESSURE PAD & PUMP Lumiscope Co., Inc. FNM Class II 1990-08-21
K901065 INFUSION PUMP Kendall Mcgaw Laboratories, Inc. FRN Class II 1990-08-21
K902166 WINGED INFUSION SET Therex Corp. FPA Class II 1990-08-17
K903307 TEMP MARQ TEMPERATURE TREND INDICATOR Marquest Medical Products, Inc. KPD Class II 1990-08-17
K902309 PARKER MICROPUMP MODEL 2100 Chathamborough Research Group, Inc. FRN Class II 1990-08-17
K903607 POWDER FREE, NON-STERILE EXAMINATION GLOVES Tillotson Rubber Co., Inc. LYY Class I 1990-08-17
K900056 CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE Abbott Laboratories FOZ Class II 1990-08-15
K902497 SCD THERAPEUTIC STOCKING SYSTEM Kendall Healthcare Products Co. Div.Of Tyco Health DWL Class II 1990-08-15
K902260 SCALE-TRONIX INCUBATOR SCALE MODEL:4050 Scale-Tronix, Inc. FRW Class I 1990-08-14
K902835 FTS-100 FLUID TRANSFER SYSTEM Richard James, Inc. FRN Class II 1990-08-10
K902601 REGENT BIOGEL DIAG PROCED GLOVES HYPOALLERG CLAIMS Regent Hospital Products LYY Class I 1990-08-10
K901394 ELASTYREN - EXAMINATION AND DENTAL GLOVES Danpren Gloves A/S LZA Class I 1990-08-10
K901640 MULTICATH PLACEMENT KIT Vygon Corp. FOZ Class II 1990-08-10
K902446 DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST Mallinckrodt Group, Inc. FMW Class I 1990-08-10
K902617 PATIENT EXAMINATION GLOVES Unicorn Latex, Ltd. LYY Class I 1990-08-10
K895644 CADD-PCA AMBULATORY INFUSION PUMPS Pharmacia Deltec, Inc. FRN Class II 1990-08-08
K901777 3M FIRST AID BANDAGE FOR MINOR WOUNDS 3M Company KGX Class I 1990-08-08
K901887 MODIFIED SEPACELL R-SERIES BLOOD FILTERS Asahi Medical Co., Ltd. CAK Class II 1990-08-08
K894506 ENTERA-FLO ENTERAL FEEDING PUMP Delmed, Inc. FRN Class II 1990-08-06
K900752 INCUBATOR 8000 Dragerwerk AG FMZ Class II 1990-08-02
K896717 PARTNER INFUSION SYSTEM: Q-Life Systems, Inc. FRN Class II 1990-08-02
K900375 BECTON DICKINSON PROGRAM 2 INFUSION PUMP Bd Becton Dickinson Vacutainer Systems Preanalytic FRN Class II 1990-08-02
K902749 OLYMPIC MINI BILI-LITE, MODEL 77 Olympic Medical Corp. LBI Class II 1990-08-02
K902135 PERCUTANEOUS INTRODUCER KIT Device Labs, Inc. FOZ Class II 1990-08-01
K900432 MODEL #M8 ELECTRONIC STERILIZER Midmark Corp. FLE Class II 1990-07-27
K902092 RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY Critikon Company, LLC FRN Class II 1990-07-26
K895924 METRICARE DRUG RESERVOIRS Metrix Co. KPE Class II 1990-07-26
K902545 VAAKA BABY SCALE Ferguson Medical FRW Class I 1990-07-26
K902474 WEEVAC 1 PORTABLE RESCUE STRETCHER W. Murphy Ent., Inc. FPP Class I 1990-07-24
K902912 THERMOSCAN-INSTANT THERMOMETER MODEL IR-4000 Thermoscan, Inc. FLL Class II 1990-07-24
K900263 ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER Arrow Intl., Inc. FOZ Class II 1990-07-24
K901845 TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX 3M Company KGX Class I 1990-07-23
K895770 EXEL HUBER INFUSION SET Exel Intl. FPA Class II 1990-07-19
K902409 BECTON DICKINSON 360 INFUSER (TM) SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic FRN Class II 1990-07-19
K902036 STERI-VAC GAS STERILIZER MODEL 5XL 3M Company FLF Class II 1990-07-19
K901706 LIGHT, HEAD, EXAMINATION Burton Medical Products Corp. KZF Class I 1990-07-19
K902344 ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER Ati FRC Class II 1990-07-19
K895710 ABBOTT LIFECARE 4100 PCA INFUSER Abbott Laboratories FRN Class II 1990-07-16
K901987 OLYMPIC BILI-LITE-PAD(TM) Olympic Medical Corp. LBI Class II 1990-07-16
K901937 CODMAN SUCTION PATTIE Codman & Shurtleff, Inc. GCX Class II 1990-07-16
K895709 ABBOTT PATIENT CONTROLLED ANALGESIA (PCA) PUMP Abbott Laboratories FRN Class II 1990-07-12
K900646 MERCURY THERMOMETERS (ORAL AND RECTAL) Abel Industries, Inc. FLK Class II 1990-07-11
K902644 BALDUR LATEX EXAMINATION GLOVES Hti Trading Group LYY Class I 1990-07-11
K901790 THERMOMETER, MERCURY/CLINICAL Perlink USA, Inc. FLK Class II 1990-07-11
K902183 S.S.C. MEDICAL PRODUCTS HOME HEALTH CARE BED Super Sagless Corp. FNL Class II 1990-07-11
K900865 ADD-A-VIAL II BINARY CONNECTOR Kendall Mcgaw Laboratories, Inc. LHI Class II 1990-07-11
K900742 RATE INFUSER PLUS Bd Becton Dickinson Vacutainer Systems Preanalytic FRN Class II 1990-07-11
K901760 LITTER, FOLDING RIGID POLE, DECONTAMINABLE Dept. of the Army FPP Class I 1990-07-10
K890736 TFV-2300 INFUSION PUMP Nihon Kohden America, Inc. FRN Class II 1990-07-09
K900134 BABY BOARDS IV SUPPORT ASSEMBLY Baby Boards, Inc. KMK Class I 1990-07-09
K902089 EQUI-GUARD (ASPIRATOR FILTER) Equi-Tron Mfg., Inc. GCX Class II 1990-07-06
K901063 LUER LOCK TRANSFER PIN Acacia, Inc. LHI Class II 1990-07-06
K901722 CHEMOSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM Device Labs, Inc. LJT Class II 1990-07-03
K900441 BURNS CASUALTY SHEET Pilgrim Medical Services FPY Class I 1990-07-03
K900771 ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR 3M Company FRC Class II 1990-07-03
K902565 ALADAN TRI-CLEAN 110 POWDERLESS LATEX GLOVE Aladan Corp. LYY Class I 1990-07-03
K900442 BURNS CASUALTY SHEET BURN ROLL Pilgrim Medical Services FPY Class I 1990-07-03
K900443 BURNS CASUALTY SHEET LIMB WRAP Pilgrim Medical Services FPY Class I 1990-07-03
K895942 GESCO DUAL LUMEN PER-Q-CATH-DL Gesco Intl., Inc. FOZ Class II 1990-07-02
K901151 I.V. ADMINISTRATION SET CONNECTING DEVICE Dmd, Div. of Casta Pacific Co. FPA Class II 1990-07-02
K902482 VITALMIX (SET & BAG) Pacific Device, Inc. LHI Class II 1990-07-02
K900048 HYPERTHERMIA SENSOR ACCESSORIES Valley Medical Research, Inc. FLL Class II 1990-07-02
K901546 NEEDLEPOINT GUARD Needlepoint Guard, Inc. FMF Class II 1990-07-02
K901588 MINIMED(R) MODEL 506 EXTERNAL INSULIN PUMP Medtronic Minimed LZG Class II 1990-07-02
K901801 LATEX PATIENT EXAMINATION GLOVES Fujian Provincial Medicines and Health Products LYY Class I 1990-06-28
K901579 LATEX EXAMINATION GLOVES P.T. Perkebunan LYY Class I 1990-06-28
K901404 NUTRIMIX MACRO TPN COMPOUNDER Abbott Laboratories LHI Class II 1990-06-26
K902346 DISPOSABLE CORONARY CONTROL SYRINGE Advance Medical Designs, Inc. FMF Class II 1990-06-26
K902463 RUBIN PATIENT EXAMINATION GLOVES P.T. Perkebunan LYY Class I 1990-06-26
K902503 HARE FOLDING BACK EMERGENCY STRETCHER Dyna Corp. FPO Class II 1990-06-26
K895867 PANCRETEC I.V. MODEL 5000 INFUSER Abbott Laboratories FRN Class II 1990-06-26
K902196 MODIFIED STICK-GARD SAFETY NEEDLE Ziehm International, Inc. FPA Class II 1990-06-26
K893769 LIFECARE MICRO PUMP (INFUSION PUMP) Abbott Laboratories FRN Class II 1990-06-26
K901877 ALLEVYN DRESSING (LABELING REVISED) Smith & Nephew United, Inc. KMF Class I 1990-06-22
K900353 SHIELDED PIGGYBACK IV NEEDLE Pascall Saringia Medical Corp. FPA Class II 1990-06-22
K901879 INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING) Smith & Nephew United, Inc. KGX Class I 1990-06-22
K901585 OHMEDA - OHIO(R) CARE PLUS INCUBATOR Ohmeda Medical FMZ Class II 1990-06-22
K901522 OLYMPIC SMART SCALE PEDIATRICS MODEL 50 Olympic Medical Corp. FRW Class I 1990-06-22
K901878 INTRASITE GEL (LABELING REVISION) Smith & Nephew United, Inc. KMF Class I 1990-06-22

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