FDA 510(k) clearances — page 872

176,637 clearances on record, most recent first.

Clearances — page 872

87,101–87,200 of 176,637

K991219 — C-FLEX URETERAL STENTSApplied Medical Resources·Product code FAD·1999-06-21
K991305 — HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVESM.R.G. Industries Sdn. Bhd.·Product code LYY·1999-06-21
K991321 — PACIFIC HEMOSTASIS THROMBOSCREEN 200Pacific Hemostasis·Product code KQG·1999-06-21
K991362 — HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)Morax·Product code JBD·1999-06-21
K991402 — DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1Dako Corp.·Product code GKZ·1999-06-21
K991454 — MOUSE IGG1 NEGATIVE CONTROLSDako Corp.·Product code GKZ·1999-06-21
K991478 — TENDER TOUCH SILICONE GEL PADSCapital Marketing Technologies, Inc.·Product code MDA·1999-06-21
K991488 — SELF CURE COMPOSITEHarry J. Bosworth Co.·Product code EBF·1999-06-21
K991491 — FLC COMPOSITEHarry J. Bosworth Co.·Product code EBF·1999-06-21
K991513 — HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVOI-Flow Corp.·Product code FPA·1999-06-21
K991742 — NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM OYty Industry (Manjung) Sdn Bhd·Product code LYY·1999-06-21
K982096 — DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURORapid Mfg. Co.·Product code GXY·1999-06-18
K990250 — HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0Morax·Product code LBT·1999-06-18
K990581 — DIRECT HDL-CHOLESTEROL REAGENTKamiya Biomedical Co.·Product code LBS·1999-06-18
K990697 — RS-4V MUSCLE STIMULATORRs Medical·Product code IPF·1999-06-18
K990953 — RENAL LINKBaxter Healthcare Corp·Product code KPF·1999-06-18
K990969 — KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSORKonica Medical Corp.·Product code IXW·1999-06-18
K990996 — GENYX MEDICAL INJECTION NEEDLEGenyx Medical, Inc.·Product code FBK·1999-06-18
K991008 — DIMENSION BITEEspe Dental AG·Product code ELW·1999-06-18
K991047 — HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)Hardcover Products, Inc.·Product code LTZ·1999-06-18
K991243 — NORMA 10Odin Technologies , Ltd.·Product code LNH·1999-06-18
K991310 — EXPLOR-X 70Villa Sistemi Medicali S.P.A.·Product code EHD·1999-06-18
K991318 — CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERASHitachi Medical Corp. of America·Product code KPS·1999-06-18
K991518 — PANATOMEImaging Sciences Intl., Inc.·Product code EHD·1999-06-18
K991671 — HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEMAdvanced Technology Laboratories, Inc.·Product code IYO·1999-06-18
K991692 — CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.·Product code CDP·1999-06-18
K991716 — HISPEED NX/I CT SCANNER SYSTEMGe Medical Systems, Inc.·Product code JAK·1999-06-18
K991751 — STATUS CUP ACCUSIGN CUPPrinceton BioMeditech Corp.·Product code DKE·1999-06-18
K983922 — DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELSDade Microscan, Inc.·Product code JWY·1999-06-17
K990925 — MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)Hardcover Products, Inc.·Product code HIS·1999-06-17
K990930 — 3D ANATOMICAL MESHSanterra Medical Technology, Inc.·Product code FTL·1999-06-17
K991179 — ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEMZeus Scientific, Inc.·Product code DDC·1999-06-17
K991526 — ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501Imagyn Medical Technologies, Inc.·Product code KXK·1999-06-17
K991657 — QUANTA LITE ANA ELISAInova Diagnostics, Inc.·Product code LLL·1999-06-17
K991876 — SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATER&D Systems, Inc.·Product code JPK·1999-06-17
K984536 — REMOVABLE CUFF ABUTMENTSulzer Calcitek, Inc.·Product code DZE·1999-06-16
K990944 — OSTEOMED INTRAORAL DISTRACTION SYSTEMOsteomed Corp.·Product code MQN·1999-06-16
K991406 — TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETERTerumo Medical Corp.·Product code FOZ·1999-06-16
K991498 — ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGALNeometrics, Inc.·Product code JIA·1999-06-16
K991858 — SSA-390A/POWER VISION 8000Toshiba America Medical Systems, In.C·Product code IYN·1999-06-16
K991872 — LYNX ULTRASOUND SYSTEMEcton, Inc.·Product code IYN·1999-06-16
K991898 — ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIREMicrovena Corp.·Product code DQX·1999-06-16
K990949 — CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORTIntersurgical, Inc.·Product code CAH·1999-06-15
K991049 — CLIMAXMedilatex Sdn. Bhd.·Product code HIS·1999-06-15
K991374 — INVIGRAIndus Medicare , Ltd.·Product code HIS·1999-06-15
K991376 — DAHEDI INSULIN INFUSION PUMPDisetronic Medical Systems·Product code LZG·1999-06-15
K991425 — XANTOPREN COMFORTHeraeus Kulzer, Inc.·Product code ELW·1999-06-15
K991599 — CADD ADMINISTRATION SETSims Deltec, Inc.·Product code FPA·1999-06-15
K991675 — MODIFICATION OF: STERRAD BI TEST PACKAdvanced Sterilization Products·Product code FRC·1999-06-15
K991811 — CORDIS MAXI DS PTA BALLOON CATHETERCordis Corp.·Product code LIT·1999-06-15
K991855 — CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXXConmedcorp·Product code GEI·1999-06-15
K984576 — K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, KTerumo Europe N.V.·Product code FMI·1999-06-14
K990859 — DEFLECTABLE TAC ELECTROTHERMAL PROBEOratec Interventions, Inc.·Product code GEI·1999-06-14
K990877 — HISTOFREEZER DEVICEOraSure Technologies, Inc.·Product code GEH·1999-06-14
K990956 — BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005Biosensor Corp.·Product code DQK·1999-06-14
K991307 — TELEMEDICINE 2000Card Guard Scientific Survival , Ltd.·Product code DXH·1999-06-14
K991758 — MONOJECT INSULIN SYRINGEThe Kendal Co.·Product code FMF·1999-06-14
K982448 — CARDIOLIGHTCapintec, Inc.·Product code DSH·1999-06-11
K983791 — PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULAEdwards Lifesciences Research Medical·Product code DWF·1999-06-11
K990183 — IMPLEX ALUMINA FEMORAL HEADImplex Corp.·Product code LZO·1999-06-11
K990852 — COOPERSURGICAL INFRARED COAGULATORCooperSurgical, Inc.·Product code KNS·1999-06-11
K990864 — SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228Boston Scientific Corp·Product code MND·1999-06-11
K990905 — PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JITPassy-Muir, Inc.·Product code JOH·1999-06-11
K991002 — PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIPV. Mueller Neuro/Spine·Product code FZP·1999-06-11
K991143 — MAGNA-ROM 21 KNEE SYSTEEMSulzer Orthopedics, Inc.·Product code JWH·1999-06-11
K991178 — FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253Richard Wolf Medical Instruments Corp.·Product code FGB·1999-06-11
K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.·Product code EFQ·1999-06-11
K991407 — SYNTHES LOCKING CALCANEAL PLATESSynthes (Usa)·Product code LXT·1999-06-11
K991447 — CARDIOQUANT CARDIAC ASSESSMENT CONTROLSSpectral Diagnostics, Inc.·Product code JJY·1999-06-11
K991630 — ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEETAdvanced Medical Solutions Group Plc·Product code MDA·1999-06-11
K991686 — LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS)Arista Latindo Industrial Ltd. P.T·Product code LYY·1999-06-11
K991824 — AT HOME DRUG TEST, MODEL 9171Phamatech·Product code MVO·1999-06-11
K991831 — BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1Boston Medical Technologies, Inc.·Product code DPS·1999-06-11
K991842 — SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGINGGe Vingmed Ultrasound·Product code IYO·1999-06-11
K980438 — 11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MTMedical Components, Inc.·Product code MPB·1999-06-10
K990246 — STERI-PAK LF BOWIE-DICK TEST PACKSteritec Products Mfg Co, Inc.·Product code JOJ·1999-06-10
K990846 — AMORPHOUS DIAMOND COATED DRILLNobel Biocare Uas, Inc.·Product code DZI·1999-06-10
K990871 — PILLOWPOSITIVE CERVICAL PILLOWLifesleep Systems, Inc.·Product code MYB·1999-06-10
K990920 — DRG TITANIUM BONE PLATEDoctor'S Research Group, Inc.·Product code JEY·1999-06-10
K991099 — AMERICAN DENTAL PRODUCTS ETCH-DETECTAmerican Dental Products, Inc.·Product code EBC·1999-06-10
K991113 — `INEAR WRIST COIL, MODEL 440GE-09Medical Advances, Inc.·Product code MOS·1999-06-10
K991127 — VARIANT II B-THALASSEMIABio-Rad·Product code JPD·1999-06-10
K991166 — K-ASSAY MICROALBUMIN CALIBRATOR SETKamiya Biomedical Co.·Product code JIX·1999-06-10
K991418 — BROWNE MVI ETHYLENE OXIDE INDICATORAlbert Browne , Ltd.·Product code JOJ·1999-06-10
K991467 — K-ASSAY RHEUMATOID FACTOR CALIBRATOR SETKamiya Biomedical Co.·Product code DHR·1999-06-10
K983839 — BIOTEST ANTI-EBV RECOMBINANTBiotest Diagnostics Corp.·Product code LSE·1999-06-09
K983841 — BIOTEST ANTI-EBV RECOMBINANT, EBNA IGGBiotest Diagnostics Corp.·Product code LSE·1999-06-09
K983842 — BIOTEST ANTI-EBV RECOMBINANT, EA IGMBiotest Diagnostics Corp.·Product code LSE·1999-06-09
K983867 — FUJI CATHETER, MODEL CTH001Windy Hill Technology, Inc.·Product code KNW·1999-06-09
K984235 — INTERSOURCE 125, MODEL 1251LInternational Brachytherapy, Inc.·Product code KXK·1999-06-09
K990063 — NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIESNihon Kohden America, Inc.·Product code CCK·1999-06-09
K990243 — FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIESFotona D.D.·Product code GEX·1999-06-09
K990809 — CADISCOPE ELECTRONIC STETHOSCOPECaditec AG·Product code DQD·1999-06-09
K990909 — MTP UROPUMP DISPOSABLE TUBING SETMtp Medical Technical Promotion GmbH·Product code LJH·1999-06-09
K990912 — MTP EXTRACTION BAGMtp Medical Technical Promotion GmbH·Product code GCJ·1999-06-09
K990954 — ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SETNsk Nakanishi, Inc.·Product code EBW·1999-06-09
K990974 — VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.·Product code EFQ·1999-06-09
K991003 — PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLIDayspring Medical, Inc.·Product code FKY·1999-06-09
K991077 — MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)Microrecording Systems Consultants, LLC·Product code GZL·1999-06-09
K991086 — CAPNOCHECK II, MODEL 8400Bci Intl., Inc.·Product code CCK·1999-06-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.