meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
37
Latest Decision
1988-09-15

Clearances · page 127 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K883614 CYTOGUARD(R) Survival Technology, Inc. FMF Class II 1988-09-15
K882556 BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI. Bd Becton Dickinson Vacutainer Systems Preanalytic FRN Class II 1988-09-15
K883311 COUNT-A-DOSE Pavel Jordan & Associates, Inc. FMF Class II 1988-09-15
K875280 STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT Steris C/O Medical Device Consultants, Inc. MED Class II 1988-09-13
K882403 OPHTHALMIC FLUID INJECTOR Trek Medical Products, Inc. FMF Class II 1988-09-09
K882506 MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0 Span-America Medical Systems, Inc. KMJ Class I 1988-09-09
K882536 OPHTHALMIC PAO VALVE Look, Inc. FMF Class II 1988-09-09
K880857 SYRINGE PUMP MS2000 Smash Ent., Inc. FRN Class II 1988-09-01
K882347 HARMAC EXTENSION INFUSION SET Harmac Medical Specialties, Inc. FPA Class II 1988-08-30
K882468 ELIMINATOR AIR FILTER Apex Medical, Inc. KDQ Class II 1988-08-29
K882361 STIHLER ASTOTHERM IFT 200, IFT 220 Stihler Electronic, C/O Worldwide Regul. Services LGZ Class II 1988-08-25
K882503 30 IV EXTENSION SET W/TWO MALE LUER LOCKS Churchill Medical Systems, Inc. FPA Class II 1988-08-25
K883473 SURGICAL CONNECTING TUBES Westmark, Sterile Packing Systems, Inc. (Sps) GAZ Class II 1988-08-25
K882159 522 INTELLIGENT PUMP Kendall Mcgaw Laboratories, Inc. FRN Class II 1988-08-24
K881767 VIGGO INSUFLON Ohmeda Medical FOZ Class II 1988-08-24
K881775 BD MICROFINE IV PEN INJECTOR Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1988-08-23
K882114 AMISCO U-100 INSULIN SYRINGE American Intl. Medical Supply Co. FMF Class II 1988-08-23
K883338 SURGICAL SEALANT APPLICATOR Micromedics, Inc. KYZ Class I 1988-08-23
K882223 PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST Deknatel, Inc. KDQ Class II 1988-08-16
K882102 PROVIDER ONE INFUSION SYSTEM Pancretec, Inc. FRN Class II 1988-08-12
K882713 REBUILDING STERILIZERS Mdt Corp., Inc. FLE Class II 1988-08-12
K882047 ENTRUST(TM) MODEL 800 Avi, Inc. FRN Class II 1988-08-11
K882107 PERFUSOR SECURA SYRINGE PUMP Burron Medical, Inc. FRN Class II 1988-08-11
K882106 PERFUSOR M SYRINGE PUMP Burron Medical, Inc. FRN Class II 1988-08-11
K882644 HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5 Huntleigh Technology, Inc. FNM Class II 1988-08-10
K881471 KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP Kimberly-Clark Corp. FRG Class II 1988-08-10
K883094 MX350 (SERIES) CONTROL SYRINGE Medex, Inc. FMF Class II 1988-08-10
K882360 DERMAPIK Creative Scientific Equipment Corp. SCL Class II 1988-08-09
K882448 MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE Bd Becton Dickinson Vacutainer Systems Preanalytic LJS Class II 1988-08-09
K882880 SAFETY, BLOOD COLLECTION TUBE HOLDER Ryan Medical, Inc. FMI Class II 1988-08-09
K881342 IMPLANTOFIX II IMPLANTABLE DRUG DELIVERY SYSTEM Burron Medical, Inc. LJT Class II 1988-08-09
K883005 ELECTRONIC DIGITAL THERMOMETER Hanson Scale Co. FLL Class II 1988-08-04
K882127 CLINICAL ELECTRONIC THERMOMETERS Sheridan Catheter Corp. FLL Class II 1988-08-04
K881976 CATHETER, INTRAVASCULAR Primrose Medical, Inc. FOZ Class II 1988-08-04
K882230 A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED Therex Corp. LJT Class II 1988-07-29
K881975 SET, INTRAVASCULAR Primrose Medical, Inc. FPA Class II 1988-07-29
K881977 PRESSURE INFUSOR Primrose Medical, Inc. KZD Class I 1988-07-29
K882025 MODIFIED EXTRAVAKIT Extravakit, Inc. FMF Class II 1988-07-27
K882533 LATEX EXAMINATION GLOVE Sukas Export FMC Class I 1988-07-21
K881446 ORMON DIGITAL FEVER THERMOMETER MODEL MC-3B Ormon Electronics, Inc. FLL Class II 1988-07-20
K882493 ROD, IRRIGATOR SUPPORTING, TELESCOPING TYPE Cambridge Technologies, Inc. FOX Class I 1988-07-19
K882332 HEADREST, PATIENT COMFORT Surgic Aid, Inc. KME Class I 1988-07-19
K882798 MULTIFLO ADAPTER Deseret Medical, Inc. FPA Class II 1988-07-18
K882797 LUER-LOK MULTIFLO ADAPTER Deseret Medical, Inc. FPA Class II 1988-07-18
K882583 LATEX EXAM GLOVES, NON-STERILE B Und J Instruments FMC Class I 1988-07-14
K881844 MAGNUM 800(TM) MANAGEMENT SYSTEM The Medical Group, Inc. FNL Class II 1988-07-14
K882100 VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT Vitaphore Corp. LJS Class II 1988-07-13
K880322 DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM Dentronix, Inc. KMH Class II 1988-07-13
K881368 CLINICAL ELECTONIC THERMOMETERS Sheridan Catheter Corp. FLL Class II 1988-07-13
K882388 MR. RAZOR II TWIN Burney Products Corp. LDQ 1988-07-13
K882092 CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM Gaymar Industries, Inc. FNM Class II 1988-07-13
K881782 MSI 4000 SERIES BED Med Service, Inc. FNL Class II 1988-07-12
K881713 SPECIAL PROCEDURES BASE UNIT MODEL 500 Gempco, Inc. FMT Class II 1988-07-12
K882302 IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080 Y FPA Class II 1988-07-12
K882304 DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL) Abco Dealers, Inc. FLL Class II 1988-07-12
K882161 ACUCAIR CUSHION CONTINUOUS AIRFLOW SYSTEM Ssi Medical Services, Inc. FNM Class II 1988-07-12
K881654 ACCI-GUARD MULTI-SAMPLE BLOOD COLLECTION NEEDLE Medical Safety Products, Inc. FMI Class II 1988-07-08
K882064 LO-CORE NEEDLE Device Labs, Inc. FMI Class II 1988-07-08
K872867 BIOSIGN Clinical Technology Corp. FRC Class II 1988-07-06
K882405 HYPODERMIC NEEDLE SHEATH HOLDER Ansr Ent., Inc. FMJ Class II 1988-06-29
K881980 RETROJECT(TM) ANTI-AIDS SYRINGE W/RETRAC. NEEDLE Habley Medical Technology Corp. FMF Class II 1988-06-28
K881963 MSI 3002 SERIES BED Med Service, Inc. FNL Class II 1988-06-28
K881964 MSI 3003 SERIES BED Med Service, Inc. FNJ Class I 1988-06-28
K882465 MODEL 172-P AND 172-N ROTARY SPRAY ARM Boling Precision Components Co. FLE Class II 1988-06-24
K880759 MODIFIED DIGITAL CLINICAL THERMOMETER Epson America, Inc. FLL Class II 1988-06-24
K880963 HAC AUTOLOGY CENTERS DISPENSING KIT FOR FIB.CON. Buckman Co., Inc. FMF Class II 1988-06-24
K882291 RETROFIT BABY FACE SHIELD (RFS) Physician Engineered Products, Inc. LBI Class II 1988-06-20
K882007 EXTENDED LIFE INJECTION SITE Baxter Healthcare Corp FPA Class II 1988-06-20
K882242 LANDMARK(TM) VENOUS ACCESS DEVICE Menlo Care, Inc. FOZ Class II 1988-06-20
K880733 BARD PCA II INFUSION PUMP C.R. Bard, Inc. FRN Class II 1988-06-20
K881252 PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE Deknatel, Inc. GCX Class II 1988-06-17
K881321 BLOOD/SOLUTION SET W/PRESSURE PUMP Baxter Healthcare Corp FPA Class II 1988-06-16
K882335 DISPOSABLE SYRINGE Baxter Healthcare Corp FMF Class II 1988-06-16
K881671 MANAN TABAR-ROTHSCHILD GALACTOGRAPHY KIT Manan Medical Devices FMI Class II 1988-06-15
K881149 MUCUS TRAP OR SUCTION TRAP Ferguson Medical KDQ Class II 1988-06-14
K881397 SANAPLAST Nebo Industries KGX Class I 1988-06-14
K881234 VENOVALVE(TM) Abbott Laboratories FPA Class II 1988-06-13
K881215 CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH Baxter Healthcare Corp FOZ Class II 1988-06-13
K882190 S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEM Harbor Medical Devices, Inc. LJT Class II 1988-06-09
K881286 TEMPA-DOT CLINICAL THERMOMETER SHEATH Pymah Corp. FQZ Class I 1988-06-08
K881969 DRY COMFORT DISPOSABLE UNDERPAD Health Tec, Inc. KME Class I 1988-06-07
K881019 BABYROCKER Cinventa AB FMS Class II 1988-06-07
K881845 HARE ANY LEVEL COT Dyna Industries, Inc. FPO Class II 1988-06-03
K881962 MSI 2005 SERIES BED Med Service, Inc. FNJ Class I 1988-06-03
K881859 DRIPRIDE DISPOSABLE UNDERPAD Weyerhaeuser Co. KME Class I 1988-06-03
K881758 VIGGO VASCUPORT NEEDLE Ohmeda Medical FMI Class II 1988-06-03
K881075 LIFEPORT II, MODEL LPS-1100 Strato Medical Corp. LJT Class II 1988-06-03
K881785 N.S. CADEE First Scientific, Div. FMI Class II 1988-05-31
K881965 MSI 5000 SERIES BED Med Service, Inc. FNL Class II 1988-05-31
K880746 STERILE NEEDLE FOR BLOOD COLLECTION Applied Plastics Technology, Inc. FMI Class II 1988-05-31
K881027 MSI 2002 SERIES BED Med Service, Inc. FNL Class II 1988-05-26
K881909 TOSHIBA DIGITAL CLINICAL THERMOMETER Toshiba Glass Co., Ltd. FLL Class II 1988-05-26
K880605 LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER Miles Laboratories, Inc. FPB Class II 1988-05-26
K881052 CHECK VALVE Baxter Healthcare Corp FPA Class II 1988-05-26
K881590 ADFUSE(TM) Healthtek, Inc. FRN Class II 1988-05-23
K875332 IVAC VOLUMETRIC PUMP - MODEL 590 Y FRN Class II 1988-05-20
K874505 CONTAIN(TM) Arbor Technologies, Inc. GCX Class II 1988-05-20
K880506 MODIFIED EVA-MIX AND DI-MIX BAGS Gil-Med Industries C/O Kegan & Kegan, Ltd. KPE Class II 1988-05-20
K881338 CONDOM-MATE VAGINAL LUBRICANT Upsher-Smith Laboratories, Inc. KMJ Class I 1988-05-16
K880693 MEDSURG MYELOGRAM TRAY Medsurg Industries, Inc. FMF Class II 1988-05-11

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