FDA 510(k) clearances — page 897

176,637 clearances on record, most recent first.

Clearances — page 897

89,601–89,700 of 176,637

K982428 — CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT)Innervision, Inc.·Product code HET·1998-10-09
K982441 — CCA-220Benson Medical Instruments Co.·Product code EWO·1998-10-09
K982687 — DISPOSABLE VINYL EXAM GLOVES, POWDEREDShanghai Antares Industries, Inc.·Product code LYZ·1998-10-09
K982691 — MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)Perusahaan Intan Emas Sdn. Bhd.·Product code LYY·1998-10-09
K982814 — MEDRAD VISTRON CT INJECTOR SYSTEMMedrad, Inc.·Product code DXT·1998-10-09
K982895 — STERNOMEGA COMPOMER CEMENTSterngold/Implamed·Product code EMA·1998-10-09
K983162 — PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASCBio-Vascular, Inc.·Product code FTM·1998-10-09
K983211 — CENTAURIPremier Laser Systems, Inc.·Product code GEX·1998-10-09
K983327 — ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMSSiemens Medical Solutions USA, Inc.·Product code LNH·1998-10-09
K983387 — ONTRAK TESTCUP AND TESTSTIK CONTROLSRoche Diagnostic Systems, Inc.·Product code DIF·1998-10-09
K983492 — BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIACBoehringer Mannheim Corp.·Product code JJY·1998-10-09
K973410 — ULTRACAMW. Edward Johansen·Product code EIA·1998-10-08
K980585 — MILLENNIUMBiolase Technology, Inc.·Product code EFB·1998-10-08
K981521 — AIA-PACK TPOAB ASSAYTosoh Medics, Inc.·Product code JZO·1998-10-08
K981522 — AIA-PACK TGAB ASSAYTosoh Medics, Inc.·Product code JZO·1998-10-08
K982436 — RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-RWoodside Biomedical, Inc.·Product code GZJ·1998-10-08
K982484 — EBI VUECATH ENDOSCOPIC SPINAL SYSTEMElectro-Biology, Inc.·Product code HRX·1998-10-08
K982547 — STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATORSteritec Products Mfg Co, Inc.·Product code JOJ·1998-10-08
K982590 — TEMPBOND CLEAR-2Sybron Dental Specialties, Inc.·Product code EMA·1998-10-08
K982732 — SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)Synthes·Product code HRS·1998-10-08
K982820 — BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEMBarco NV Display Systems·Product code LLZ·1998-10-08
K983222 — PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64Medical Advances, Inc.·Product code MOS·1998-10-08
K972960 — HEALTH CHECK URI-TEST PROTEIN IN URINETcpi, Inc.·Product code JIR·1998-10-07
K974248 — WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEMAir-Shields, Inc.·Product code HGM·1998-10-07
K974854 — HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207Morax·Product code JHO·1998-10-07
K980186 — ZYMED TELEMETRY SYSTEMAgilent Technologies·Product code DSI·1998-10-07
K980953 — ACCU-BITE HOME KIT DISCLUDERJerome M. Simon·Product code MQC·1998-10-07
K981048 — HYDRAGEL 6 CSF KITMorax·Product code CFF·1998-10-07
K981084 — URISCREENDiatech Diagnostics,Inc.·Product code JXA·1998-10-07
K982389 — ODC B2 BIPOLAR CUPOrtho Development Corp.·Product code KWY·1998-10-07
K982406 — COBE VACUUM RELIEF CHECK VALVECobe Cardiovascular, Inc.·Product code MJJ·1998-10-07
K982417 — INNERDYNE STEP TROCAR EXPANDABLE PORT, STEPInnerdyne, Inc.·Product code GCJ·1998-10-07
K982425 — CODA MPX30 MOTION ANALYSIS SYSTEMPinsco Inc. Dba B & L Engineering·Product code LXJ·1998-10-07
K982603 — QUANTA LITE CHROMATIN ELISAInova Diagnostics, Inc.·Product code LLL·1998-10-07
K982659 — MEDIVISION HYSTEROSCOPEMedivision Scope Service Center, Inc.·Product code HIH·1998-10-07
K982679 — MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TESTSpectral Diagnostics, Inc.·Product code DDR·1998-10-07
K973970 — SPO2 FINGER PROBESMedical Cables, Inc.·Product code DQA·1998-10-06
K980906 — TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-COTransonic Systems, Inc.·Product code MQS·1998-10-06
K981024 — QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS SYSTEM)Marquette Medical Systems, Inc.·Product code LOS·1998-10-06
K982196 — DIGITAL RADIOGRAPHIC IMAGING SYSTEMGE Medical Systems·Product code KPR·1998-10-06
K982245 — TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIABiosite Incorporated·Product code MHI·1998-10-06
K982387 — E.CAM EXTRA HIGH ENERGY COLLIMATORSiemens Medical Solutions USA, Inc.·Product code KPS·1998-10-06
K982444 — 7250 ULTRASOUND IMAGING SYSTEMBiosound Esaote, Inc.·Product code IYO·1998-10-06
K982563 — ULTRAPRO MODEL 98Ramsoft, Inc.·Product code LLZ·1998-10-06
K982564 — DELTON FS DIRECT DELIVERY SYSTEMDentsply Intl.·Product code EBC·1998-10-06
K982631 — PHILIPS TOMOSCAN CSPhilips Medical Systems, Inc.·Product code JAK·1998-10-06
K982683 — TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSIONTelex Communications, Inc.·Product code EPF·1998-10-06
K982690 — BARCO MEDICAL DISPLAY CONFORMITY AND CONSISTENCY SOFTWAREBarco N.V.·Product code LLZ·1998-10-06
K983109 — MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANYMedical Advances, Inc.·Product code MOS·1998-10-06
K983321 — MICROFUSE DUAL RATE INFUSERBaxa Corp.·Product code FRN·1998-10-06
K971549 — VMT SYSTEMTarget Health, Inc.·Product code LXV·1998-10-05
K981445 — ULTIMA AIRFLOW SENSOR, 0510Braebon Medical Corp.·Product code BZQ·1998-10-05
K982064 — ACTION STORM RANGER II, ACTION STORM POWER 9000Invacare Corp.·Product code ITI·1998-10-05
K982099 — MOMENTUM NO. FS008 WHEELCHAIRSriram Enterprises D.B.A. Momentum Group·Product code IOR·1998-10-05
K982489 — RFG-3C PLUSRadionics, Inc.·Product code GXD·1998-10-05
K982490 — TENOR SPINAL SYSTEMSofamor Danek USA,Inc.·Product code KWP·1998-10-05
K982550 — BROWSER (EVENT SOFTWARE) MODEL # 4500ERespironics, Inc.·Product code BZQ·1998-10-05
K982583 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXLShimadzu Corp.·Product code JAK·1998-10-05
K982585 — DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORDINATE ULTRA KNEE REVISION SYSTEMDePuy Orthopaedics, Inc.·Product code JWH·1998-10-05
K982734 — OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USEThe Olympus Optical Co.·Product code ODG·1998-10-05
K982783 — VAIL 1000 ENCLOSED BEDVail Products, Inc.·Product code FNL·1998-10-05
K982849 — PANTHER WHEELCHAIRSnug Seat, Inc.·Product code IOR·1998-10-05
K982886 — OTI MODULAR SHOULDER SYSTEMOsteoimplant Technology, Inc.·Product code HSD·1998-10-05
K982905 — MVM 7.5 FRENCH FLEXIBLE URETEROSCOPEKarl Storz Endoscopy·Product code FGB·1998-10-05
K982918 — DEPUY C-STEM SYSTEMDePuy Orthopaedics, Inc.·Product code JDI·1998-10-05
K982989 — QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTRSunrise Medical, Inc.·Product code IOR·1998-10-05
K983121 — NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220Syntec Scientific Corp.·Product code HTY·1998-10-05
K980484 — AESCULAP SPINE SYSTEM EVOLUTIONAesculap, Inc.·Product code MNI·1998-10-02
K982358 — HISTOFREEZER DEVICEOraSure Technologies, Inc.·Product code GEH·1998-10-02
K982359 — NC-STATNeurometrix, Inc.·Product code JXE·1998-10-02
K982375 — STRYKER HIP ARTHOROSCOPY SETStryker Endoscopy·Product code HRX·1998-10-02
K982538 — BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABPBelmont Instrument Corp.·Product code DSP·1998-10-02
K982598 — OTI FEMORAL LOCK TOTAL HIP SYSTEMOsteoimplant Technology, Inc.·Product code JDI·1998-10-02
K982670 — CONTEMPORARY ACETABULAR COMPONENTHowmedica Corp.·Product code JDI·1998-10-02
K982907 — MAGNATEK 40Magna Advanced Technologies, Inc.·Product code DQA·1998-10-02
K982914 — AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTSAesculap, Inc.·Product code MNI·1998-10-02
K983027 — TRIMETHOPRIM/SULPHAMETHOXAZOLEAb Biodisk·Product code JWY·1998-10-02
K980812 — IMX HOMOCYSTEINEAxis Biochemicals, Asa·Product code DFC·1998-10-01
K981295 — UPROAbbott Laboratories·Product code JGQ·1998-10-01
K981345 — CHOLESTRON PRO II CHOLESTEROL TESTLifestream Diagnostics, Inc.·Product code CHH·1998-10-01
K981630 — VYGON DOUBLE LUMEN UMBILICAL CATHETERSchiff & Co.·Product code FOS·1998-10-01
K981861 — LINER 1:HARD RELINE LIQUIDHarry J. Bosworth Co.·Product code EBI·1998-10-01
K982848 — COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECTRoche Diagnostic Systems, Inc.·Product code MRR·1998-10-01
K983023 — MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEMCordis Corp.·Product code DYB·1998-10-01
K972140 — A1 ACOUSTIC RHINOMETERG.M. Instruments , Ltd.·Product code BXQ·1998-09-30
K972675 — CO2 GAS WARMING UNIT (6-800-00)Northgate Technologies, Inc.·Product code HIF·1998-09-30
K972866 — HEMOCHRON JR. MIOCROCOAGULATION CITRATED PTInternational Technidyne Corp.·Product code GJS·1998-09-30
K973203 — THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIESSangstat Medical Corp.·Product code DAK·1998-09-30
K973447 — OMNIFLATOR 6630(6-630-00)Northgate Technologies, Inc.·Product code HIF·1998-09-30
K974170 — DUOSTARMti Corp./ Electrostar S.A.-Haiti·Product code GEI·1998-09-30
K980839 — AVOCET PTAvocet Medical, Inc.·Product code JPA·1998-09-30
K981337 — DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834AMesure Technology·Product code FLL·1998-09-30
K981711 — SYSMEX AUTOMATED COAGULATION ANALYZER CA-500Dade Behring, Inc.·Product code JPA·1998-09-30
K981876 — SYNTHETIC EXAMINATION GLOVE, POWDEREDHsing YI Plastics Processing Co, Ltd.·Product code LYZ·1998-09-30
K982020 — METRON QA-IDS I.V. PUMP TESTERMetron U.S., Inc.·Product code FRN·1998-09-30
K982113 — UMECO OPTIMA 694 RUBY LASER SYSTEMUmeco, Inc.·Product code GEX·1998-09-30
K982256 — OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMPMckinley, Inc.·Product code MEB·1998-09-30
K982349 — SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERSSiemens Medical Solutions USA, Inc.·Product code JAK·1998-09-30
K982422 — EAGLESOFT CHAIRSIDEEaglesoft, A Patterson Co.·Product code LLZ·1998-09-30
K982440 — NITRILE PATIENT EXAMINATION GLOVEPerusahaan Getah Asas Sdn. Bhd.·Product code LZA·1998-09-30

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