meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
41
Latest Decision
1986-12-29

Clearances · page 132 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K864076 HERCON ANTISEPTIC TRANSPARENT DRESSING Hercon Laboratories Corp. KGX Class I 1986-12-29
K864778 MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC Mac Lee Medical Products FMF Class II 1986-12-29
K864783 MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC Mac Lee Medical Products FMF Class II 1986-12-23
K864780 MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC Mac Lee Medical Products FMF Class II 1986-12-23
K864782 MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC Mac Lee Medical Products FMF Class II 1986-12-23
K864692 EXTENSION SETS Salt Creek Medical Technologies FPK Class II 1986-12-18
K863606 BUTTERFLY NON-CORING NEEDLE SET Cormed, Inc., Sub. C.R.Bard, Inc. FMI Class II 1986-12-18
K864414 SEAL SYRINGE (3CC,5CC,12CC,20CC,30CC & 50CC) Seal Syringe Corp. FMF Class II 1986-12-18
K864405 MANAN CONTRAST MEDIA ADMINISTRATION SET Manan Manufacturing Co., Inc. FPA Class II 1986-12-18
K863122 ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. Surgicot, Inc. FRC Class II 1986-12-17
K864395 LOW VOLUME EXTENSION SET Panamedix, Inc. FPK Class II 1986-12-16
K864164 CRIS ADAPTED WITH VOLUME LIMITING BAG Y FPA Class II 1986-12-16
K864761 USI AUTOJECT INSULIN SYRINGE Ulster Scientific, Inc. FMF Class II 1986-12-16
K864229 STA-SET MODEL 250 I.V. FLOW REGULATOR Sta-Set Corp. LDR Class II 1986-12-16
K864015 STERILABELS Diversatronics, Inc. LDQ 1986-12-12
K863997 ABBOTT LIFECARE(R) 4100 PCA INFUSER Abbott Laboratories FRN Class II 1986-12-12
K864517 MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS Medtronic Minimed FRN Class II 1986-12-12
K862153 ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE Arrow Intl., Inc. FOZ Class II 1986-12-11
K863304 PRESELECTED FLOW RATE I.V. SET Migada, Ltd. FPA Class II 1986-12-09
K861725 INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT Parke-Davis Co. FOZ Class II 1986-12-04
K864038 SUPERCATH I.V. CATHETER Togo Medikit Co., Ltd. FOZ Class II 1986-12-04
K863750 HICKMAN(TM) SUBCUTANEOUS PORT W/DETACHED CATHETER C.R. Bard, Inc. LJT Class II 1986-12-01
K864397 DISPOSABLE PHARMASEAL TEMPERATURE MONITORING PROBE American Pharmaseal Div. Ahsc FLL Class II 1986-12-01
K864556 AQUALUBE(TM) Parker Laboratories, Inc. KMJ Class I 1986-12-01
K864555 3 RING ATTACHMENT Professional Medical Services FMF Class II 1986-12-01
K863796 CREATIVE CARE SYSTEMS' IV START KIT American Biomaterials Corp. LRS Class II 1986-11-28
K864124 SPAND-GEL GRANULATED GEL Medi-Tech Intl. Corp. KMF Class I 1986-11-26
K863646 ESOPHAGEAL RECTAL TEMPERATURE PROBE Respiratory Support Products, Inc. FLL Class II 1986-11-25
K863981 STERILIZATION WRAPS #620,624,648,640,636,630,612 Graham Medical Products FRG Class II 1986-11-25
K864116 ANAGO ISOLATION MASK (#80-950) Anago, Inc. LGM Class II 1986-11-25
K864106 SR-MODEL 230 (MODIFICATION) Hirata Sangyo Co. USA, Inc. FRN Class II 1986-11-19
K864195 SURFACE SKIN TEMP PROBE W/THERMOCOUPLE TYPE T Respiratory Support Products, Inc. FLL Class II 1986-11-19
K864338 SECONDARY SET LOCK Travenol Laboratories, S.A. FPA Class II 1986-11-19
K864160 LEUKOPLAST(R) POROUS AND SPORT TAPE Beiersdorf, Inc. KGX Class I 1986-11-17
K862412 INTESTOPLANT Burron Medical Products, Inc. LLD Class II 1986-11-13
K864172 HILL-ROM CENTURY CC, MODELS 891 & 893 WEIGHING SYS Hill-Rom, Inc. FNL Class II 1986-11-13
K864186 HILL-ROM CENTURY CC MODELS 892 &894 (RADIOLUCENT) Hill-Rom, Inc. FNL Class II 1986-11-13
K864269 MODEL 35-B ALL LEVEL COT Ferno-Washington, Inc. FPO Class II 1986-11-13
K853827 LIFE-PORT IMPLANTABLE VASCULAR ACCESS Strato Medical Corp. LJT Class II 1986-11-13
K864089 HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA Hitachi Sales Corporation of America FLL Class II 1986-11-07
K864203 NESBIT EVANS NURSING HOME BED J. Nesbit Evans & Co. FNJ Class I 1986-11-07
K864176 GENTLE FEEL Mali, Inc. HFS Class I 1986-11-04
K864044 ESOPHAGEAL/RECTAL TEMPERATURE PROBE W/TYPE T Respiratory Support Products, Inc. FLL Class II 1986-11-04
K863040 DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS Cher Mel Corp. KPE Class II 1986-10-31
K863753 FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000 Foundations Plus, Inc. KGX Class I 1986-10-30
K863723 NORFOLK NORPORT/SUBCUTAN. IMPLANTED DRUG DEPOT Norfolk Medical Products, Inc. LJT Class II 1986-10-29
K863712 I.V. START KIT, STERILE, DISPOSABLES Busse Hospital Disposables, Inc. LRS Class II 1986-10-22
K862495 STARCRAFT ELITE AUTOCLAVE Starcraft Medical Corp. FLE Class II 1986-10-22
K863633 SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES Biological & Environmental Control Laboratories LDQ 1986-10-16
K862432 HEPACRON PUREAIR-ZONE SYSTEM Hepacron, Inc. FRF Class II 1986-10-16
K863814 BAG SPIKE EXTENSION SET Med Fusion Systems, Inc. FPA Class II 1986-10-14
K863305 HICKMAN SUBCUTANEOUS PORT W/PRE-ATTACHED CATHETER C.R. Bard, Inc. LJT Class II 1986-10-10
K863748 HOSPITAL BED Global Medical Prods, Inc. FNJ Class I 1986-10-09
K863683 BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP C.R. Bard, Inc. FRN Class II 1986-10-07
K863208 OHMEDA AUXILIARY POWER SYSTEM Ohmeda Medical FMT Class II 1986-10-03
K863514 PROMEDICOR Terra Marketing Assoc. FMI Class II 1986-09-25
K862492 EXEL THREE-WAY STOPCOCK Exel Intl. FMG Class II 1986-09-25
K863511 IMMOBILIZING VACUUM MATRESS (IVM) Omnium Services Partners, Inc. FPP Class I 1986-09-25
K862959 MERIVAARA PATIENT TROLLEY - MODEL #416 Global Medical Prods, Inc. FPO Class II 1986-09-25
K863561 URESIL THORACIC VENT Uresil Corp. KDQ Class II 1986-09-23
K862289 KOREAN GREEN CROSS SCALP VEIN SET Sturbridge Medical FPA Class II 1986-09-23
K862295 MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER Imed Corp. FRN Class II 1986-09-23
K863152 MEDSENTRY FLOTATION SYSTEM Medsentry Corp. FNM Class II 1986-09-23
K862441 EZ LOAD MODEL 30, ALL LEVEL COT Ferno-Washington, Inc. FPO Class II 1986-09-12
K863296 INFUSE-A-PORT EXPLANT KIT Intermedics/Infusaid, Inc. LJT Class II 1986-09-11
K863181 HEALTHCHECK THERM-STRIP Healthcheck Corp. FQZ Class I 1986-09-11
K860353 SYRINGE INFUSION PUMP Travenol Laboratories, S.A. FRN Class II 1986-09-05
K863083 BETA MEDICAL PRODUCTS EMR-301 HYDRAULIC STRETCHER Beta Medical Products Co. FPO Class II 1986-09-03
K862477 HOYER DIGITAL ELECTRONIC SCALE Ted Hoyer & Co., Inc. FRW Class I 1986-09-03
K863204 DEKA JR. Deka Research & Development Corp. LDR Class II 1986-09-03
K862018 MICRO PORT Intermedics/Infusaid, Inc. LJT Class II 1986-09-03
K860952 I.V. SET WITH AND WITHOUT AIR VENT Migada, Ltd. FPA Class II 1986-08-27
K862491 EXEL BUTTERFLY SCALP VEIN SET Exel Intl. FPA Class II 1986-08-27
K862927 CADD-1, MODEL 5100 HF Deltec Systems, Inc. FRN Class II 1986-08-27
K861563 VITAGUARD PERCUTANEOUS INFECTION CONTROL KIT Vitaphore Corp. LJS Class II 1986-08-27
K863179 KIMLON DISPOSABLE BLANKET Kimberly-Clark Corp. KME Class I 1986-08-27
K861623 MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER Luxtron FLL Class II 1986-08-19
K861586 LOPEZ VALVE Icu Medical, Inc. MJF Class II 1986-08-18
K862772 V. MUELLER (R) GOOSENECK CIRCULAR STAPLER American V. Mueller GAG Class II 1986-08-18
K862130 COMFORT-SET* I.V. CATHETER PLACEMENT UNIT. Menlo Care, Inc. FOZ Class II 1986-08-14
K862241 STANDARD BASIN KIT CUSTOM BASIN KIT Quali-Med, Inc. FRG Class II 1986-08-01
K861539 NIKKISO INFUSION PUMP MODEL PFA-02 International Medical Products, Inc. FRN Class II 1986-07-31
K862653 LUER LOCK ADAPTER/NUT Mallinckrodt Critical Care FPA Class II 1986-07-31
K862480 BT CATH (INTRAVASCULAR CATHETER) Baron Technologies, Inc. FOZ Class II 1986-07-31
K862691 STOPCOCK Ram Development FMG Class II 1986-07-28
K861598 INTELLIGRAPH(TM) PROGRAMMER Intelligent Medicine, Inc. FRN Class II 1986-07-24
K861299 HYGIENIC AIR PURIFYING DEVICE Puridyne, Inc./Imutech, Inc. FRF Class II 1986-07-23
K861644 CRITIKON 48-HOUR AIR ELIMINATING FILTER Critikon Company, LLC FPB Class II 1986-07-22
K862273 BETAFLO 2000 Betaflo, Inc. LDR Class II 1986-07-18
K855101 ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR Surgicot, Inc. FRC Class II 1986-07-17
K861390 DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET Baxter Healthcare Corp FMI Class II 1986-07-17
K853332 HDC CHEMO-PORT (VASCULAR) Hdc Corp. LJT Class II 1986-07-17
K862146 BOMDAL TRAVELMASTER LIFT Bomdal Medical Equipment, Inc. FNG Class II 1986-07-15
K861608 UNICARE BREAST SHELLS Unicare Medical Products, Inc. HFS Class I 1986-07-15
K860528 THE KEYMED FIBERSCOPE STERILIZATION CASE Keymed, Inc. KCT Class II 1986-07-15
K861977 BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR Biomedical Dynamics, Inc. KZD Class I 1986-07-15
K861781 DELIVERY ROOM WARMER Air-Shields, Inc. FMT Class II 1986-07-15
K862147 BOMDAL STANDARD LIFT Bomdal Medical Equipment, Inc. FNG Class II 1986-07-15
K861557 APLICARE SKIN PROTECTANT PREP PAD Aplicare, Inc. NEC Class I 1986-07-11
K862333 (MT-27) THERMOMETER AND (M-10PC) PROBE COVERS Sharp Electronics Corp. FLL Class II 1986-07-08

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