FDA 510(k) clearances — page 952

176,637 clearances on record, most recent first.

Clearances — page 952

95,101–95,200 of 176,637

K970951 — GRASS BRAINWAVE SOFTWAREAstro-Med, Inc.·Product code OLV·1997-05-19
K971231 — WHITE RIVER MINI MANUAL BREAST PUMPWhite River Concepts·Product code HGY·1997-05-19
K953647 — MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATINGMeadox Medicals, Div. Boston Scientific Corp.·Product code LIT·1997-05-16
K963767 — MANAN V.S. ACCESS NEEDLE/SETManan Medical Products, Inc.·Product code FGE·1997-05-16
K964605 — BRAUN THERMOSCAN PRO-2000 INSTANT THERMOMETER (PRO-2000)Thermoscan, Inc.·Product code FLL·1997-05-16
K970295 — FLEXICAIR EXLIPSE PLUSHill-Rom, Inc.·Product code IOQ·1997-05-16
K970362 — CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEMApex Metal, Inc.·Product code FNM·1997-05-16
K970596 — DHD EMERALD PRODUCTDhd Diemolding Healthcare Div.·Product code BWF·1997-05-16
K970649 — HERO 642Micro-Mega·Product code EKS·1997-05-16
K970659 — DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVERTelediagnostic Systems, Inc.·Product code GYE·1997-05-16
K970716 — OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGEOpticon Medical, Inc.·Product code EZL·1997-05-16
K970915 — DSL ESTRONE-SULFATE RIADiagnostic Systems Laboratories, Inc.·Product code CGF·1997-05-16
K971124 — TM MICRO-CATHETERSXomed, Inc.·Product code ETD·1997-05-16
K971177 — IMMULITE VITAMIN B12 (LKVB1,LKVB5)Diagnostic Products Corp.·Product code CDD·1997-05-16
K971203 — SYNCHRON SYSTEMS THYROXINE REAGENTBeckman Instruments, Inc.·Product code KLI·1997-05-16
K971463 — ALP REAGENT SETCarolina Liquid Chemistries Corp.·Product code CJE·1997-05-16
K971524 — TOTAL PROTEIN OR TPCarolina Liquid Chemistries Corp.·Product code CEK·1997-05-16
K963904 — P.H.D. - PERSONAL HEART DEVICE MODEL 5258Heart Alert, Inc.·Product code DXH·1997-05-15
K964584 — AMBU SPUR NEONATEAmbu, Inc.·Product code BTM·1997-05-15
K964832 — HEWLETT-PACKARD CENTRALVUE SOFTWAREHewlett-Packard Co.·Product code DSI·1997-05-15
K970639 — NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-KMedicotest, Inc.·Product code GXY·1997-05-15
K971148 — 700-SP SERIES DISPOSABLE STIMULATION ELECTRODESCardiotronics Systems, Inc.·Product code MKJ·1997-05-15
K971390 — QUANTUM 3080SP SURGICAL TABLESTERIS Corporation·Product code GDC·1997-05-15
K964518 — FAST-CATH TRANSSEPTAL CATHETER INTRODUCERDaig Corp.·Product code DYB·1997-05-14
K964796 — ODYSSEY I DENTAL WATER UNITGermiphene Corp.·Product code EIA·1997-05-14
K964869 — NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITORThe Magstim Company , Ltd.·Product code ETN·1997-05-14
K964961 — MODEL 405T WITH ETCO2 OPTIONIvy Biomedical Systems, Inc.·Product code CCK·1997-05-14
K965052 — D3 (PHEMFILCON A) UV OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSESWesley Jessen Corp.·Product code LPL·1997-05-14
K965232 — CALTAG CAL-LYSECaltag Laboratories, Inc.·Product code GKZ·1997-05-14
K970428 — REST X SYSTEMRestxsys·Product code FNM·1997-05-14
K970522 — MYERSON'S ECONOMY DENTURE BASE MATERIALAustenal, Inc.·Product code EBI·1997-05-14
K970562 — TENOSNARELuxtec Corp.·Product code HRX·1997-05-14
K970694 — MODEL 1700, HYDRO PREPPhysiometrix, Inc.·Product code GYB·1997-05-14
K970784 — ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T)Alexander Mfg. Co.·Product code DXG·1997-05-14
K970787 — ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3)Alexander Mfg. Co.·Product code DPS·1997-05-14
K970799 — ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)Alexander Mfg. Co.·Product code LIF·1997-05-14
K970850 — SCANRITE DFSScanrite Systems·Product code EHD·1997-05-14
K970881 — CEDIA DIGOXINBoehringer Mannheim Corp.·Product code KXT·1997-05-14
K970947 — B-350 CEILING MOUNTED C-POSITIONEROmega Medical Imaging, Inc.·Product code JAA·1997-05-14
K971000 — EPISTAXIS NASAL PACKInvotec International, Inc.·Product code EMX·1997-05-14
K971109 — QUIKPAC II ONE STEP AMPHETAMINE TESTDrial Consultants, Inc.·Product code DKZ·1997-05-14
K971365 — PHILIPS INTEGRIS H5000Philips Medical Systems North America, Inc.·Product code IZI·1997-05-14
K971452 — MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLESiemens Medical Solutions USA, Inc.·Product code IZZ·1997-05-14
K964132 — MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENTBio-Logic Systems Corp.·Product code EWO·1997-05-13
K964391 — CHASE LEFT VENT SAFETY VALVEChase Medical, Inc.·Product code DWF·1997-05-13
K964405 — MBI ILLUMINATED RETINAL PICKM.B. Industries, Inc.·Product code MPA·1997-05-13
K964553 — MBI CO-AXIAL ILLUMINATED RETINAL PICKM.B. Industries, Inc.·Product code MPA·1997-05-13
K970667 — NUVO-LASE 660 LASER SYSTEMAmerican Laser Medical·Product code GEX·1997-05-13
K970699 — AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLESYeong Jiuh Corp.·Product code HQY·1997-05-13
K970724 — QUICKPAC II ONE STEP METHAMPHETAMINE TESTDrial Consultants, Inc.·Product code DKZ·1997-05-13
K970914 — CHASE AORTIC PERFUSION CANNULAChase Medical, Inc.·Product code DWF·1997-05-13
K971041 — CHASE CORONARY OSTIAL PERFUSION CANNULAChase Medical, Inc.·Product code DWF·1997-05-13
K971208 — MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKSMedline Industries, Inc.·Product code GAM·1997-05-13
K971412 — SUNGLASSESTeam Chien Industrial Co., Ltd.·Product code HQY·1997-05-13
K961631 — ODONT HEX SYSTEMOdontit S.A.·Product code DZE·1997-05-12
K963340 — MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECEContinuum Biomedical, Inc.·Product code GEX·1997-05-12
K970094 — MODEL DX MICRO COMPUTER CONTROLInvacare Respiratory Corp.·Product code ITI·1997-05-12
K970509 — INNOFLOUR CALIBRATOR REAGENT SETOxis Intl., Inc.·Product code DLJ·1997-05-12
K970510 — INNOFLOUR TOPIRAMATE REAGENT SETOxis Intl., Inc.·Product code MSL·1997-05-12
K970517 — INNOFLUOR TOPIRAMATE CONTROL SETOxis Intl., Inc.·Product code LAS·1997-05-12
K970536 — MEDISYSTEMS TRANDUCER PROTECTORMedisystems Corp.·Product code FIB·1997-05-12
K970556 — SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.·Product code CGA·1997-05-12
K970564 — DYNAMIC WEDGEMitsubishi Electronics America, Inc.·Product code IYE·1997-05-12
K970586 — BRAINLAB MICRO MULTI-LEAF COLLIMATORBrainlab Med. Computersysteme GmbH·Product code IYE·1997-05-12
K970628 — GE ADVANTAGE DIGITIZER WORKSTATIONGe Medical Systems, Inc.·Product code LMD·1997-05-12
K970702 — SPECTRUM DESIGNS SPECTRAGELSpectrum Designs, Inc.·Product code MDA·1997-05-12
K971236 — GREINER VACUETTE BLOOD COLLECTION TUBEGreiner America, Inc.·Product code JKA·1997-05-12
K971239 — GREINER VACUETTE BLOOD COLLECTION TUBEGreiner America, Inc.·Product code JKA·1997-05-12
K971353 — DSL ACTIVE NON-EXTRACTION IGF-I ELISADiagnostic Systems Laboratories, Inc.·Product code CFL·1997-05-12
K954577 — WS FREQUENCY SPECTRUM EFFECT PHYSIATRICS APPARATUSC.A.I. Industries Corp.·Product code ILY·1997-05-09
K961608 — SYNTHES (U.S.A.) POLYPINSynthes (Usa)·Product code HTY·1997-05-09
K961805 — TOMEY DTL ELECTRODETomey Corporation USA·Product code HLZ·1997-05-09
K963256 — NEUROMATE STEREOTACTIC SYSTEMIntegrated Surgical Systems, S.A.·Product code HAW·1997-05-09
K964239 — COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZERSpegas Industries, Ltd.·Product code CCK·1997-05-09
K964302 — HEARTPORT THORACIC TROCARHeartport, Inc.·Product code DRC·1997-05-09
K964644 — AD-TECH'S DEPTH ELECTRODEAd-Tech Medical Instrument Corp·Product code GZL·1997-05-09
K964710 — BLEDSOE COLD CONTROLMed Technology, Inc.·Product code ILO·1997-05-09
K964781 — IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENTBeckman Instruments, Inc.·Product code DDS·1997-05-09
K965103 — WINMAX SOFTWARE SYSTEMSDiagnostic Products Corp.·Product code JJF·1997-05-09
K970426 — VALUETRODEAxelgaard Mfg. Co., Ltd.·Product code GXY·1997-05-09
K970441 — K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTHMedi-Flex Hospital Products, Inc.·Product code FPX·1997-05-09
K970494 — HANNIBAL GUIDEWIRESchneider (Europe) GmbH·Product code DQX·1997-05-09
K970496 — HEARTPORT MAZE SYSTEM: CRYOPROBE SETHeartport, Inc.·Product code OCL·1997-05-09
K970516 — SULLIVAN AUTOSET HOME NASAL CPAP SYSTEMResmed, Ltd.·Product code BZD·1997-05-09
K970587 — AD-TECH SUBDURAL ELECTRODEAd-Tech Medical Instrument Corp·Product code GYC·1997-05-09
K970710 — STAT PROFILE ULTRA M ANALYZERNova Biomedical Corp.·Product code CHL·1997-05-09
K970725 — OPTI-PLAST XL 5.5 F PTA CATHETERVas-Cath, Inc.·Product code LIT·1997-05-09
K970746 — SEE3 (LOTRAFILCON A) SOFT CONTACT LENSCiba Vision Corporation·Product code LPL·1997-05-09
K970748 — TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEMSmith & Nephew, Inc., Orthopaedic Div.·Product code KTT·1997-05-09
K970757 — FOTONA SKINSCANMedical Laser Solutions·Product code GEX·1997-05-09
K970779 — OSTEONICS TIBIAL TRAY SCREW HOLE PLUGSOsteonics Corp.·Product code LZN·1997-05-09
K970982 — T-RX RETRIEVAL FORCEPSTri-Med Specialties, Inc.·Product code OCZ·1997-05-09
K971048 — PERI-STRIPS DRY - STAPLE LINE REINFORCEMENTBio-Vascular, Inc.·Product code FTM·1997-05-09
K971327 — UNIKAEyewear Partners Co.·Product code HQY·1997-05-09
K971389 — ECLIPSE 400 MANUALLY OPERATED WHEELCAIRPdg Product Design Group, Inc.·Product code IOR·1997-05-09
K960441 — STERITEC INTEGRAPH MODEL CI-101Steritec Products Mfg Co, Inc.·Product code JOJ·1997-05-08
K964069 — DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEMSiemens Medical Solutions USA, Inc.·Product code IZH·1997-05-08
K965102 — ACROMED PEDICLE SCREWAcromed Corp.·Product code MNH·1997-05-08
K965224 — EMPOWER ANTERIOR DIRECT SCREWSSmith & Nephew Richards, Inc.·Product code KWP·1997-05-08
K970455 — DUKAL NON ADHERENT DRESSINGDukal Corp.·Product code EFQ·1997-05-08

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