meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
41
Latest Decision
1987-09-09

Clearances · page 130 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K873175 CENTRAL SUPPLY ROOM WRAP Ulti-Med Intl., Inc. FRG Class II 1987-09-09
K872228 PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM American Pharmaseal Div. Ahsc FNM Class II 1987-09-04
K872233 INJECT-EASE Palco Laboratories, Inc. KZH Class II 1987-09-04
K872820 SAFETY SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1987-09-04
K871965 JMS NEEDLES AND JMS SYRINGES Jms Co., Ltd. FMF Class II 1987-09-04
K870801 FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD Travenol Laboratories, S.A. FRN Class II 1987-09-04
K872795 CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE Medex, Inc. FPA Class II 1987-09-04
K872944 LOOK SPRING-ASSIST SYRINGES Look, Inc. FMF Class II 1987-09-04
K873109 MODEL CC-72 CAVERNOSOMETRY/CAVERNOSOGRAPHY SET Life-Tech Intl., Inc. OJA Class II 1987-08-28
K872566 MULTIPLE NEEDLE, INJECTION, DISPOSABLE Cotran Corp. FMI Class II 1987-08-25
K872446 MODIFIED INSTAFIL Instafil, Inc. LHI Class II 1987-08-25
K872838 NORFOLK NORPORT (TM) -SP (SKIN PARALLEL) Norfolk Medical Products, Inc. LJT Class II 1987-08-25
K871443 CASANDRA SYRINGE CAP Casandra Medical Corp. FMF Class II 1987-08-18
K872850 RATE INFUSER SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic FRN Class II 1987-08-14
K872580 HR (TM) COLLECTION SYSTEM Icu Medical, Inc. FMI Class II 1987-08-13
K872975 LIGHTPLAST(TM) Beiersdorf, Inc. KGX Class I 1987-08-13
K860688 MONOJECT PHARMACY TRAY Sherwood Medical Co. FMF Class II 1987-08-06
K872754 HEALTH-PAK/WYCOMBE CSR WRAP Health-Pak, Inc. FRG Class II 1987-08-06
K872358 STA-PUT Design Technologies, Inc. KMI Class I 1987-08-06
K872594 ANDOVER MOLESKIN Andover Coated Products, Inc. KGX Class I 1987-08-04
K872634 CUTTER PUREFLO PLUS IV FILTER Miles Laboratories, Inc. FPB Class II 1987-08-04
K871889 COMPRESSION LEGGING DEVICE A-T Surgical Mfg. Co., Inc. LLK Class II 1987-08-04
K872149 SURECATH-ITP PERCUTANEOUS ACCESS KIT Titan Medical, Inc. LJT Class II 1987-08-04
K872067 STERICAP ASSEMBLY AND REPLACEMENT TRAY Stericap Systems FMG Class II 1987-08-04
K872066 STERICAP STOPCOCK Stericap Systems FMG Class II 1987-08-04
K872593 ANDOVER ADHESIVE TAPE, SURGICAL Andover Coated Products, Inc. KGX Class I 1987-08-04
K870950 UNIPORT MODEL SD-60, SD-70 Healthcare Technologies, Inc. LJT Class II 1987-08-04
K870995 SCALP VEIN SET Mac Lee Medical Products FPA Class II 1987-07-31
K872868 ASPEN ESMARK BANDAGE Aspen Laboratories, Inc. FQM Class I 1987-07-31
K870817 MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT C.R. Bard, Inc. LJT Class II 1987-07-30
K872584 FORTEC MI-306, MI-327 DIGITAL THERMOMETER Nam Tai , Ltd. FLL Class II 1987-07-27
K872821 INFUSION PUMP ENCLOSURE Pharmacia Deltec, Inc. FRN Class II 1987-07-27
K871728 MODIFIED LIFECARE(R) 4100 PCA INFUSER Abbott Laboratories FRN Class II 1987-07-27
K871908 IV ADMINISTRATION SET Travenol Laboratories, S.A. BRZ Class II 1987-07-27
K872729 INFUSION STAND Camtec FOX Class I 1987-07-23
K872527 OMRON DIGITAL FEVER THERMOMETER MODEL MC-12B Omron Electronics, Inc. FLL Class II 1987-07-23
K871950 VIA-GUARD Surgimark, Inc. JOL Class II 1987-07-23
K871798 FILM AND PAPER COMBINATION STERILIZING BAG Cost Rite Health Products, Inc. FRG Class II 1987-07-21
K871843 TWO FLUID W/CHECK VALVE Panamedix, Inc. FPA Class II 1987-07-21
K871084 NITROGLYCERINE PUMP SET Churchill Corp. FRN Class II 1987-07-16
K872313 NEEDLE & BLADE COUNTER & DISPOSAL UNIT Gary Plastic Packaging Corp. MMK Class II 1987-07-02
K871142 ULTIMATE PROTECTIVE SAFETY CAP (UPS CAP) Peachtree Medical, Inc. FMI Class II 1987-06-29
K864984 ROBINJECT International Medical Products, Inc. KZE Class II 1987-06-29
K870866 THE GRIPPER(TM) PORT-A-CATH NEEDLES Pharmacia, Inc. FPA Class II 1987-06-25
K871771 COMFORTWEIGH Curlington Industrial Electronics, Inc. FRW Class I 1987-06-24
K871209 NORFOLK MEDICAL NORPORT Norfolk Medical Products, Inc. LJT Class II 1987-06-24
K871842 TWO FLUID I.V. SETS Panamedix, Inc. FPA Class II 1987-06-24
K871998 GROSHONG CV CATHETER REPAIR KIT Catheter Technology Corp. LJS Class II 1987-06-24
K871841 THREE FLUID I.V. SETS Panamedix, Inc. FPA Class II 1987-06-24
K871546 SAFESIDE(TM) LUMED Luther Medical Products, Inc. FOZ Class II 1987-06-17
K871449 ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG Pa Medical Corp. KPE Class II 1987-06-17
K871888 DIGITAL FEVER THERMOMETER MODEL MC-5 Omron Electronics, Inc. FLL Class II 1987-06-17
K870330 SP55 SYRINGE PUMP Vickers , Ltd. FRN Class II 1987-06-15
K871732 CHURCHILL-H VENTED IV SET W/METERING CHAMBERS Churchill Corp. FPA Class II 1987-06-15
K871085 EXTENSION TUBE PUMP SET Churchill Corp. FPK Class II 1987-06-15
K871086 IV PUMP SET Churchill Corp. FPA Class II 1987-06-15
K872128 K-GEL Taro Pharmaceuticals, Inc. KMJ Class I 1987-06-12
K871192 SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT Norfolk Medical Products, Inc. LJT Class II 1987-06-10
K870222 AMEDA AMECARE(R) NEONATAL INCUBATOR Hollister, Inc. FMZ Class II 1987-06-10
K870223 AMEDA AMELETTE(R) NEONATAL INCUBATOR Hollister, Inc. FMZ Class II 1987-06-10
K871740 LYOSHEET SURGICAL SHEET FOR BURNS Acme United Corp. FPY Class I 1987-06-09
K870742 AMERICAN LUBRICATING JELLY STERILE 2.7G & 5G Span-America Medical Systems, Inc. KMJ Class I 1987-06-05
K871594 BIRTHING ROOM WARMER Air-Shields, Inc. FMT Class II 1987-06-05
K871753 MASTER MEDICAL DEVICE IS I.V. STAT 2 The Master Medical Corp. FPA Class II 1987-06-05
K871399 OHIO(R) CARE PLUS INCUBATOR Ohmeda Medical FMZ Class II 1987-06-05
K870992 IMED(R) MODEL 965A VOLUMETRIC INFUSION PUMP Imed Corp. FRN Class II 1987-06-04
K870991 IMED(R) MODEL 960A VOLUMETRIC INFUSION PUMP Imed Corp. FRN Class II 1987-06-04
K871672 STERILIZATION INDICATOR FOR FLASH STERILIZATION Propper Mfg. Co., Inc. LRT Class II 1987-06-01
K871202 FLASHPAK CONTAINER SYSTEM Performance Instruments Corp. FRG Class II 1987-05-29
K871281 IV START KIT The Jarid Group, Inc. LRS Class II 1987-05-27
K870572 ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT Arrow Intl., Inc. JOL Class II 1987-05-26
K871203 BED PATIENT PRESENCE MONITOR Human Technologies, Inc. KMI Class I 1987-05-26
K871104 OLYMPIC SMART SCALE Olympic Medical Corp. FRW Class I 1987-05-22
K871725 DRIPRIDE DISPOSABLE UNDERPADS Weyerhaeuser Co. KME Class I 1987-05-15
K862282 RAPIDEX BIOLOGICAL SURFACTANT Rapidex of London FLG Class I 1987-05-11
K871465 THERMOMETER SHEATHS Abco Dealers, Inc. FLL Class II 1987-05-11
K871475 SOLOLIFT - PATIENT TRANSFER STRETCHER Adel Medical , Ltd. FMR Class I 1987-05-11
K870863 FNA THYROID BIOPSY KIT Flint Laboratories Div. Travenol FMI Class II 1987-05-08
K870187 NORFOLK NORPORT, SUBCUT. IMPLANTED DRUG DEL. DEPOT Norfolk Medical Products, Inc. LJT Class II 1987-05-07
K870276 HEATED INSTRUMENT BATH Simpson/Basye, Inc. LRJ Class I 1987-05-07
K870759 CLEANING SOLUTION, CATALOG NO. 8203 Treace Medical, Inc. LRJ Class I 1987-05-07
K871629 FOLDING LITTER SUPPORT, NSN6530-00-660-0034 Junkin Safety Appliance Co., Inc. FPP Class I 1987-05-06
K870886 LIFEPORT VASCULAR ACCESS SYSTEM W/0.76 MM CATHETER Strato Medical Corp. LJT Class II 1987-05-06
K870524 AMBULATORY INFUSION PUMP DRUG RESERVOIR Med Fusion Systems, Inc. FRN Class II 1987-05-06
K870403 CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE Burron Medical Products, Inc. FOZ Class II 1987-05-01
K871556 MERIVAARA EMERGENCY PATIENT TROLLEY #436 Global Medical Prods, Inc. FPO Class II 1987-04-30
K871540 SWIVEL CONNECTORS #014452/#014453/#014459-120 Clinical Connections, Inc. FPK Class II 1987-04-30
K871007 ANTI NEEDLE STRIKE ANTI DRUG ABUSE HYPO. SYRINGE Habley Medical Technology Corp. FMF Class II 1987-04-30
K870518 SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT Surgitek FMF Class II 1987-04-29
K870147 CARERITE & COST RITE NYLON STERILIZATION FILM Cost Rite Health Products, Inc. FRG Class II 1987-04-23
K870770 TIMLEINE(TM) VENIPUNCTURE SYSTEM Ipax, Inc. KMK Class I 1987-04-23
K870581 LIFEPORT(R) 7 INCH CONTINUOUS INFUSION SET Strato Medical Corp. FPA Class II 1987-04-23
K870582 LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE Strato Medical Corp. FPA Class II 1987-04-23
K861687 BIOJECTOR SYRINGE SYSTEM Bioject, Inc. KZE Class II 1987-04-23
K870444 HOMEPRO II VOLUMETRIC INFUSION PUMP American Edwards Laboratories FRN Class II 1987-04-17
K870975 MODIFIED CASTLE POWERCLAVE Castle Co. FLE Class II 1987-04-17
K865029 CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER Travenol Laboratories, S.A. FPB Class II 1987-04-17
K870192 DISPOSABLE SYRINGE TUBERCULIN W/NEEDLE Can-Am Surgical Corp. FMF Class II 1987-04-16
K870956 OMRON DIGITAL FEVER THERMOMETER MODEL MC-7 Omron Electronics, Inc. FLL Class II 1987-04-16
K870190 DISPOSABLE SYRINGE W/O NEEDLE Can-Am Surgical Corp. FMF Class II 1987-04-16

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