meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
33
Latest Decision
1988-05-11

Clearances · page 128 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K874546 SIM MODULE Critikon Company, LLC FRN Class II 1988-05-11
K881236 TORAY ANTHRON P-U CATHETERS Toray Industries (America), Inc. FOZ Class II 1988-05-11
K881745 INFUSE-A-PORT RADIOPAQUE POLYURETHANE CATHETER Shiley Infusaid, Inc. LJT Class II 1988-05-11
K875316 BIONICA MDS 110 PCA Bionica, Inc. FRN Class II 1988-05-11
K881666 HR(TM) INTRAVASCULAR CATHETER Icu Medical, Inc. FOZ Class II 1988-05-06
K880838 BASSINET STAND WITH DRESSING TRAY Serv-Queen, Inc. FMS Class II 1988-04-29
K880928 MARQUETTE MEDICAL, INC. IV EXTENSION SETS Marquette Medical, Inc. FPA Class II 1988-04-29
K875348 MODEL 400A INFUSION PUMP Avi, Inc. FRN Class II 1988-04-29
K875347 MODEL 210A INFUSION PUMP Avi, Inc. FRN Class II 1988-04-29
K881390 NEEDLE SHIELD NEEDLE DISPOSAL UNIT Xenetics Biomedical, Inc. FPA Class II 1988-04-29
K875365 MODEL 200A INFUSION PUMP Avi, Inc. FRN Class II 1988-04-29
K880305 LIFEPORT LOW PROFILE VASCULAR ACCESS PORT W/CATH. Strato Medical Corp. LJT Class II 1988-04-26
K880204 CADD-TPA(TM) MODEL 5600 AMBULATORY INFUSION PUMP Pharmacia Deltec, Inc. FRN Class II 1988-04-25
K880479 IMED(R) GEMINI(TM) PC-1 VOLUMETRIC INFUSION PUMP Imed Corp. FRN Class II 1988-04-25
K881509 LEUKOPOR(TM) SURGICAL TAPE Beiersdorf, Inc. KGX Class I 1988-04-22
K881256 NON CORING INFUSION SET Taris Corp. LJT Class II 1988-04-21
K880207 EXPANDOVER ELASTIC BANDAGE Expandover C/O Hale and Dorr KGX Class I 1988-04-21
K880569 TEAMMATE(TM) Infusion Systems Corp. FRN Class II 1988-04-21
K880892 BLOOD COLLECTING NEEDLE AND HOLDERS Abco Dealers, Inc. FMI Class II 1988-04-21
K880623 MINIMED MODEL 404-SP EXTERNAL INFUSION PUMP Medtronic Minimed FRN Class II 1988-04-21
K880625 HALF HOUR INFUSOR Baxter Healthcare Corp FRN Class II 1988-04-19
K870874 CSPI SPECIMEN TRAP (NON-STERILE) Custom Surgical Products, Inc. GCX Class II 1988-04-19
K875297 JAMES TENDOS (SYRINGE HOLDER) Med-Text Intl. FMF Class II 1988-04-19
K880260 SAFECATH Phase Medical Systems, Inc. FOZ Class II 1988-04-19
K880026 CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS Churchill Corp. FPB Class II 1988-04-14
K880025 CHURCHILL 0.22 MICRON LIQUID FILTER SETS Churchill Corp. FPB Class II 1988-04-14
K875364 MODIFIED PCA INFUSER Bd Becton Dickinson Vacutainer Systems Preanalytic FRN Class II 1988-04-13
K881371 COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE Cox Sterile Products, Inc. KMH Class II 1988-04-13
K875276 PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM Pharmacia Deltec, Inc. LJT Class II 1988-04-13
K880027 CHURCHILL 1.2 MICRON LIQUID FILTER SET Churchill Corp. FPB Class II 1988-04-13
K881043 FOLDING HOSPITAL COT NSN 6530-00-299-8517 Junkin Safety Appliance Co., Inc. FNJ Class I 1988-04-12
K880537 POLE, INTRAVENOUS Ferguson Medical FOX Class I 1988-04-06
K874725 SITE SOLUTION ADMINISTRATION SET Site Microsurgical Systems, Inc. FPA Class II 1988-04-01
K880578 LAKE DISPOSABLE PROBE COVER Lake Medical Products, Inc. FLL Class II 1988-03-31
K880894 ALLERGIST SYRINGES Abco Dealers, Inc. FMF Class II 1988-03-31
K875193 INDISTRIP (STERILIZATION PROCESS INDICATOR) Indilab, Inc. JOJ Class II 1988-03-31
K875174 RATEMINDER V INFUSION PUMP Critikon Company, LLC FRN Class II 1988-03-29
K880704 CERULLO SUCTION REGULATOR Aesculap Instruments Corp. GCX Class II 1988-03-29
K880072 PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM Pharmacia Deltec, Inc. LLD Class II 1988-03-29
K881020 SURGICAL SEALANT DISPENSER (SSD) Micromedics, Inc. KYZ Class I 1988-03-25
K880006 STA-SET I.V. FLOW REGULATOR Controlled Flow , Ltd. LDR Class II 1988-03-24
K872998 VITAACCESS (TM) CATHETER INTRODUCER SYSTEM Vitaphore Corp. FOZ Class II 1988-03-24
K874306 INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE Busse Hospital Disposables, Inc. LGM Class II 1988-03-22
K880482 SECONDARY SOLUTION ADMINISTRATION SET W/SHEATH Baxter Healthcare Corp FPA Class II 1988-03-18
K880964 POLYDERM PEC(TM), POROUS ELASTIC COVER Laivan Corp. KGX Class I 1988-03-17
K875082 O.P.C. INTRAVASCULAR CATHETER Taut, Inc. FOZ Class II 1988-03-08
K880571 CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM Catheter Technology Corp. LJT Class II 1988-03-04
K880048 BLADE, SURGICAL PREP RAZOR STRAIGHT Crescent Corp. LDQ 1988-03-04
K874916 TECHNICON CHEM 1(TM) SYSTEM Technicon Instruments Corp. LDR Class II 1988-03-03
K875213 SURECATH - ITP II PERCUTANEOUS PORT ACCESS DEVICE Titan Medical, Inc. LJT Class II 1988-03-03
K874481 IVAC(R) VOLUMETRIC CONTROLLER - MODEL 290 Y LDR Class II 1988-03-03
K874694 ADAP-TEMP, MODEL: AT-100 Respiratory Support Products, Inc. FLL Class II 1988-03-01
K874491 IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+ Y LDR Class II 1988-02-25
K880342 UROSTHESIA Medical Research Innovators, Inc. FMF Class II 1988-02-25
K874877 PEGASUS AIRWAVE SYST/SPEC MATTRESS DECUBITUS ULCER Pegasus Airwave, Inc. FNM Class II 1988-02-22
K875074 VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 Timeter Instrument Corp. KDP Class II 1988-02-22
K874181 BAXTER BEDSIDE SYSTEM Travenol Laboratories, S.A. FRN Class II 1988-02-22
K880385 KIMBERLY-CLARK PROFESSIONAL JACKET Kimberly-Clark Corp. FME Class I 1988-02-19
K880538 TRACK AND CARRIER, INTRAVENOUS Ferguson Medical FOX Class I 1988-02-19
K875214 A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM Therex Corp. LJT Class II 1988-02-19
K874602 ASD-BIO ANTI-STICK DEVICE Biosurge, Inc. FMI Class II 1988-02-19
K880297 SEA - PORT INFUSION SET Harbor Medical Devices, Inc. LJT Class II 1988-02-19
K875315 I.V. START KITS Ni-Med, Inc. LRS Class II 1988-02-17
K875097 DISPOSABLE SYRINGE California Ent. FMF Class II 1988-02-16
K875186 IV EXTENSION SET Marquette Medical, Inc. FPK Class II 1988-02-16
K880350 YUE/FA DISPOSABLE SYRINGE Honway International Co. FMF Class II 1988-02-16
K880174 JMS TRANSFUSION SET Jms Co., Ltd. BRZ Class II 1988-02-16
K875155 60 ML RESERVOIR BAG, ITEM #200 Prn Services, Inc. KPE Class II 1988-02-16
K874495 ADCOMP 4000 HP SYSTEM Healthtek, Inc. LHI Class II 1988-02-16
K875148 MEDICRAT, HYPODERMIC SYRINGES & NEEDLES Knowltech Ind., Inc. FMF Class II 1988-02-11
K874564 MINIMED III INFUSION PUMP & UNI-SET ADMIN SET Medtronic Minimed FRN Class II 1988-02-11
K875037 STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BED Stryker Corp. FNL Class II 1988-02-11
K874801 ORTHODERM THERAPY BED Health Products, Inc. FNM Class II 1988-02-05
K874807 EXTRAVAKIT Cancer Technologies, Inc. FMF Class II 1988-02-04
K874747 10CC SYRINGE CONTROL RING SET Procedure Products, Inc. FMF Class II 1988-02-04
K874514 HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE Mallinckrodt Critical Care FLL Class II 1988-01-29
K874813 OMED WOUND CLOSURE STRIPS Oxboro Medical Intl., Inc. FPX Class I 1988-01-29
K874307 MODEL DMC-75 MINI-CATHETER SET Life-Tech Intl., Inc. FPA Class II 1988-01-29
K874644 STEAM AUTOCLAVE CONTROL. & DATALOG. BY DATACON Pharmetics, Inc. FLE Class II 1988-01-27
K870820 IVY COMMANDER (MODEL 500) Ivy Medical, Inc. LDR Class II 1988-01-20
K873465 VAN DELLEN BACTERIA FILTER Van Dellen, Ltd. FPK Class II 1988-01-20
K874581 IVAC(R) DUAL RATE ADAPTER - MODEL 70090 Y FPA Class II 1988-01-19
K874579 COEUR CONTROL SYRINGE Coeur Laboratories, Inc. FMF Class II 1988-01-19
K875270 INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS Air-Shields, Inc. FMT Class II 1988-01-19
K874649 CADD-PLUS(TM) MODEL 5400 AMBULATORY INFUSION PUMP Pharmacia Deltec, Inc. FRN Class II 1988-01-19
K875234 MON-A-THERM'S SKIN TEMPERATURE SENSOR Mon-A-Therm, Inc. FLL Class II 1988-01-19
K873792 SEPACELL R-500 AND SEPACELL R-500A Advocacy International, Ltd. CAK Class II 1988-01-19
K875177 J&J SCALP VEIN INFUSION SETS Critikon Company, LLC FOZ Class II 1988-01-14
K874133 MX710 SERIES VASCULAR ACCESS INFUSION SET Medex, Inc. FPA Class II 1988-01-14
K873205 TYMPANIC TEMPERATURE SENSOR Respiratory Support Products, Inc. FLL Class II 1988-01-14
K874414 HYPODERMIC NEEDLES, SINGLE LUMEN Harbor Medical Devices, Inc. FMI Class II 1988-01-14
K874520 MODIFIED AIRWAY TEMPERATURE SENSOR Mon-A-Therm, Inc. FLL Class II 1988-01-06
K874568 HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR Mallinckrodt Critical Care FLL Class II 1988-01-06
K873666 PALL LEUKOCYTE REMOVAL FILTER, BLOOD Pall Biomedical Products Co. CAK Class II 1988-01-06
K873746 AUTO SYRINGE MODEL AS20G INFUSION PUMP Baxter Healthcare Corp FRN Class II 1988-01-06
K873667 PALL LEUKOCYTE REMOVAL FILTER, PLATELETS Pall Biomedical Products Co. CAK Class II 1988-01-06
K871881 MODEL 3000 INFUSION PUMP Bd Becton Dickinson Vacutainer Systems Preanalytic FRN Class II 1988-01-06
K874521 MODIFIED THERMAL WELL TEMPERATURE SENSOR Mon-A-Therm, Inc. FLL Class II 1988-01-06
K872953 DISPOSABLE I.V. ADMINISTRATION SET Mac Lee Medical Products FPA Class II 1988-01-06
K874524 MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR Mon-A-Therm, Inc. FLL Class II 1988-01-06

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