FDA 510(k) clearances — page 1189

176,637 clearances on record, most recent first.

Clearances — page 1189

118,801–118,900 of 176,637

K921075 — PHADEBACT MONOCLONAL GC TEST, MODIFICATIONKaro Bio Diagnostics AB·Product code LIC·1992-05-22
K921124 — MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADSMedtronic Vascular·Product code DTB·1992-05-22
K921463 — PHILIPS 31 SERIES IN THE EAR HEARING AIDPhilips Hearing Instruments Co.·Product code ESD·1992-05-22
K921847 — ACTION FX MANUAL WHEELCHAIRInvacare Corp.·Product code IOR·1992-05-22
K920821 — UNIMAX MODEL 2000 COLOR-CORRECTED MICROSPOT CO2Reliant Laser Corp.·Product code GEX·1992-05-21
K921550 — LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CPSt. Jude Medical, Inc.·Product code KFM·1992-05-21
K913181 — AUTOLOGOUS BLOOD PROCESSING SYSTEMLifestream Int'L, Inc.·Product code CAC·1992-05-20
K913395 — EZ-1 SYSTEM RESPIRATORY EFFORT SENSORSPro-Tech, Inc.·Product code BZG·1992-05-20
K914754 — MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 540-DMedtronic Bio-Medicus, Inc.·Product code DWA·1992-05-20
K914984 — E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATIONE-Z-Em, Inc.·Product code DQY·1992-05-20
K914986 — GUIDE WIRES, MODIFICATIONE-Z-Em, Inc.·Product code DQX·1992-05-20
K914987 — HIGH PRESSURE CONNECTING SETS, MODIFICATIONE-Z-Em, Inc.·Product code DTL·1992-05-20
K915211 — MICROCHAMBERRespiratory Delivery Systems, Inc.·Product code CAF·1992-05-20
K920091 — IOWA ORAL PERFORMANCE ISNTRUMENTBreakthrough, Inc.·Product code IKE·1992-05-20
K920436 — MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATORMedtronic Vascular·Product code IPF·1992-05-20
K920567 — MODELS 3987 AND 3988 RESUME LEAD FOR PNSMedtronic Vascular·Product code GZF·1992-05-20
K920690 — NOROTRACK 360 INCLINOMETERNoromed, Inc.·Product code KQX·1992-05-20
K920307 — AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTIONAusonics Pty , Ltd.·Product code ITX·1992-05-19
K921775 — SPYROFLEX WOUND CLOSURESPolymint Industrial Co. , Ltd.·Product code FPX·1992-05-19
K904579 — SPORICIDIN BRAND DISINFECTANT TOWELETTESSporicidin Intl.·Product code LRJ·1992-05-18
K904580 — SPORICIDIN BRAND DISINFECTANT SPRAYSporicidin Intl.·Product code LRJ·1992-05-18
K904581 — SPORICIDIN BRAND DISINFECTANT SOLUTIONSporicidin Intl.·Product code LRJ·1992-05-18
K914589 — SABRATEK 3030 INFUSION PUMPSabratek Corp.·Product code FRN·1992-05-18
K915388 — LAPAROCOPIC MYOMA SCREWCook Urological, Inc.·Product code HHO·1992-05-18
K915412 — HYSTEROSCOPIC MYOMA SCREWCook Urological, Inc.·Product code HHO·1992-05-18
K920718 — DISPOSABLE POSTERIOR MICROSCISSORSStorz Instrument Co.·Product code HQE·1992-05-18
K920756 — FELDMUHLE CERAMIC HEADLink America, Inc.·Product code LZO·1992-05-18
K921255 — PHILIPS BV26 MOBILE C-ARM STANDPhilips Medical Systems, Inc.·Product code OXO·1992-05-18
K921278 — M-2000 DIAGNOSTIC AND TELERADIOLOGY WORKSTATIONMetecon, Inc.·Product code LMD·1992-05-18
K922065 — TELEX MODEL M29 ITE CUSTOM HEARING AIDTelex Communications, Inc.·Product code ESD·1992-05-18
K922066 — TELEX MODEL 28A ITE CUSTOM HEARING AIDTelex Communications, Inc.·Product code ESD·1992-05-18
K910625 — ULTRACALMSion Technology, Inc.·Product code LWM·1992-05-15
K913209 — ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.·Product code DXK·1992-05-15
K914565 — OSTEONICS 7000 POSTERIOR STAB. TOTAL KNEE FEM. COMOsteonics Corp.·Product code JWH·1992-05-15
K915202 — INTERNAL MODEM FOR THE E560 ELECTROCARDIOGRAPHSiemens Burdick, Inc.·Product code LOS·1992-05-15
K915567 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE(ACCESORY)Fonar Corp.·Product code LNH·1992-05-15
K915828 — INJECTION SITE WITH LUER LOCKBaxter Healthcare Corp·Product code FPA·1992-05-15
K920094 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIESSiemens Medical Solutions USA, Inc.·Product code LNH·1992-05-15
K920524 — OSTEONICS 7000 SERIES TOTAL KNEE BONE AUGMENTATIONOsteonics Corp.·Product code JWH·1992-05-15
K920577 — HOWEDICA ZIRCONIA FEMORAL HEADHowmedica Corp.·Product code LZO·1992-05-15
K920842 — AEROSOL DELIVERY SYSTEMSHospitak, Inc.·Product code LRD·1992-05-15
K920949 — SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5Heraeus Kulzer, Inc.·Product code GKZ·1992-05-15
K920988 — ATMOS MIRROR WARMERJedmed Instrument Co.·Product code LRC·1992-05-15
K920994 — HOOD NASAL SEPTAL BUTTONHood Laboratories·Product code LFB·1992-05-15
K921085 — PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR)Hear-Well Technologies, Inc.·Product code EWO·1992-05-15
K921098 — MAGNETOM 63SPSiemens Medical Solutions USA, Inc.·Product code LNH·1992-05-15
K921101 — PHILIPS INTEGRIS V3000 FILMPhilips Medical Systems, Inc.·Product code IZI·1992-05-15
K921191 — GIANTURCO-ROSCH BILIARY Z STENTCook, Inc.·Product code FGE·1992-05-15
K921257 — EURION LOTOS P HEARING AIDManro Corp.·Product code ESD·1992-05-15
K921501 — DELUXE C ARM RADIOLOGICAL TABLE, MODEL #056-004Biodan Medical Systems, Ltd.·Product code IZZ·1992-05-15
K914941 — SIMON BREAST LESION LOCALIZATION NEEDLEManan Medical Products, Inc.·Product code GDF·1992-05-14
K914955 — K-DEFIB/PACE ELECTRODEKatecho, Inc.·Product code DRO·1992-05-14
K915066 — DISPOSABLE SKIN MARKERAmerican Medical Mfg., Inc.·Product code FZZ·1992-05-14
K915560 — LO-PROFILE EXTENSION SETDouglas Medical Products Corp.·Product code FPK·1992-05-14
K920004 — PBI MULTILASE D COPPER VAPOR LASERWm.I.Kern & Co., Inc.·Product code GEX·1992-05-14
K920058 — SUPERGLOVESSempermed Glove Industries Sdn Bhd·Product code LYY·1992-05-14
K920206 — POSEY SITTERJ. T. Posey Co.·Product code KMI·1992-05-14
K921629 — N-TACT(R) PTH SP KITIncstar Corp.·Product code CEW·1992-05-14
K915874 — BASKET LITTER CARRIERBradco Med , Ltd.·Product code FPP·1992-05-13
K920013 — UNI-DOSE SYRINGE PUMPElectrochemical Drug Delivery, Inc.·Product code FRN·1992-05-13
K920240 — SOLUMBRA SUN PROTECTIVE CLOTHINGWetmore Assoc., Inc.·Product code MIW·1992-05-13
K920812 — FAIRBANKS BABY SCALEFairbanks Scales, Inc.·Product code FRW·1992-05-13
K921013 — SYVA EMIT II METHAQUALONE ASSAYSyva Co.·Product code KXS·1992-05-13
K921596 — SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECESharplan Lasers, Inc.·Product code GEX·1992-05-13
K921625 — CALCIUM-ARSENAZO III REAGENT SETPointe Scientific, Inc.,·Product code CIC·1992-05-13
K921646 — NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENONNextec Corp.·Product code FST·1992-05-13
K903014 — ALPHA-STIM CSElectromedical Products, Inc.·Product code QJQ·1992-05-12
K910616 — LB-2000 CRANIAL ELECTROTHERAPY STIMULATORLife Balance Intl., Inc.·Product code QJQ·1992-05-12
K914966 — TSRH CENTRAL POST HOOKSSofamor Danek Mfg., Inc.·Product code KWP·1992-05-12
K915323 — THE BELTONE AUDIO SCOUTBeltone Electronics Corp.·Product code EWO·1992-05-11
K915411 — DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMABaxter Diagnostics, Inc.·Product code GJT·1992-05-11
K915819 — BRAINSCAN WORKSTATIONBrainlab Medizinische Computersysteme GmbH·Product code HAW·1992-05-11
K920280 — SUTURE REMOVAL KIT, STERILE, DISPOSABLETrinity Laboratories, Inc.·Product code MCZ·1992-05-11
K920409 — DACOMED BATTERY OPERATED VACUUM ERECTION DEVICEDacomed Corp.·Product code LKY·1992-05-11
K920492 — HIGH VACHygoplastic, Inc.·Product code DYN·1992-05-11
K920517 — MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISPTrinity Laboratories, Inc.·Product code KKX·1992-05-11
K920600 — DAB DETECTION KITVentana Medical Systems, Inc.·Product code DEY·1992-05-11
K920700 — SEAMLESS LATEX PATIENT EXAM GLOVESDigitcare Corp.·Product code LYY·1992-05-11
K921055 — KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTERKendall Healthcare Products Co. Div.Of Tyco Health·Product code KNY·1992-05-11
K921331 — CAMBRIDGE PC/GXT STRESS TEST SYSTEMHealth Watch, Inc.·Product code DPS·1992-05-11
K921369 — BIOMEDICAL HORIZONS MODEL 1001Biomedical Horizons, Inc.·Product code KNN·1992-05-11
K921439 — BISCO CORE PASTEBisco, Inc.·Product code EBF·1992-05-11
K921535 — SUOENA AFFINITY (TM) MODEL #802Coloplast Corp.·Product code KCZ·1992-05-11
K910925 — DISINFECTION WITH THE COX DRY HEAT STERILIZERCox Sterile Products, Inc.·Product code KMH·1992-05-08
K914180 — DESERET(R) FLOW RESTRICTION VALVEBecton Dickinson Vascular Access, Inc.·Product code FOZ·1992-05-08
K914577 — RHYTHMSCAN PRECISION 6000Precision Health Care Systems, Inc.·Product code DQK·1992-05-08
K914887 — ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCTMallinckrodt Medical·Product code FRQ·1992-05-08
K915109 — RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SETBallard Medical Products·Product code FPA·1992-05-08
K915230 — H WAVE MUSCLE STIMULATORElectronic Waveform Laboratory, Inc.·Product code IPF·1992-05-08
K915477 — STERILIZATION BAG, POLYESTER/WRAPCgs Supplies Corp.·Product code KCT·1992-05-08
K920566 — AEC DETECTION KITVentana Medical Systems, Inc.·Product code DEY·1992-05-08
K920582 — 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.Site Microsurgical Systems, Inc.·Product code HQE·1992-05-08
K920773 — DURAFUSE INFUSION PUMPBd Becton Dickinson Vacutainer Systems Preanalytic·Product code FRN·1992-05-08
K921420 — AZITHROMYCIN, 15 MCG, SENSI DISCBd Becton Dickinson Vacutainer Systems Preanalytic·Product code JTN·1992-05-08
K921441 — INTERFERENTIAL STIMULATOR MODEL INF 4150/ABiomedical Life Systems, Inc.·Product code LIH·1992-05-08
K921656 — LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLESiemens Hearing Instruments, Inc.·Product code ESD·1992-05-08
K920109 — IMX INSULINAbbott Laboratories·Product code CFP·1992-05-07
K920571 — TRIAL LENS SETR.H. Burton Co.·Product code HPC·1992-05-07
K920926 — KEMTROL SERUM CONTROL-ABNORMALHelena Laboratories·Product code JJY·1992-05-07
K921016 — SYNERMED ALT/GPT REAGENT KITSynermed, Inc.·Product code CKA·1992-05-07

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