FDA 510(k) clearances — page 950

176,637 clearances on record, most recent first.

Clearances — page 950

94,901–95,000 of 176,637

K970578 — RADIONICS BURR HOLE VALVERadionics, Inc.·Product code JXG·1997-06-04
K970865 — ISG FAMILY OF VIEWING WANDSI.S.G. Technologies, Inc.·Product code HAW·1997-06-04
K970905 — SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENTBeckman Instruments, Inc.·Product code CHI·1997-06-04
K971066 — TAMARYN I.V. FLOW REGULATOR EXTENSION SETTamaryn Medical Systems, Inc.·Product code FPA·1997-06-04
K971220 — GREINER VACUETTE BLOOD COLLECTION TUBEGreiner America, Inc.·Product code JKA·1997-06-04
K971350 — SERIES XE, SERIES SE, SERIES TEMicro-Mega Societe Anonyme·Product code EGS·1997-06-04
K971424 — DERMACLEAN X-AM (PROTEIN LABELING CLAIM) EXAMINATION GLOVESAnsell Perry·Product code LYY·1997-06-04
K971465 — NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYSNational Healthcare Mfg. Corp.·Product code HOY·1997-06-04
K971551 — DUQIAODuqiao Glasses (Group) Co. , Ltd.·Product code HQY·1997-06-04
K971575 — BENCHMARK-IVJ.F. Jelenko & Co., Inc.·Product code EJT·1997-06-04
K971603 — STERILE SUREFLEX FILES AND INSTRUMENTSDentsply Intl.·Product code EFA·1997-06-04
K964549 — ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCERAloka Co., Ltd.·Product code ITX·1997-06-03
K965204 — AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANTAvanta Orthopaedics, Inc.·Product code KYI·1997-06-03
K970243 — CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATORCynosure, Inc.·Product code GEX·1997-06-03
K970523 — SOLORanger All Season Corp.·Product code INI·1997-06-03
K970774 — TEMPOCEM NE (MULTIPLE)Foremost Dental Mfg., Inc.·Product code EMA·1997-06-03
K970775 — TEMPO CEM (MULTIPLE)Foremost Dental Mfg., Inc.·Product code EMA·1997-06-03
K970791 — INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTYCustom Services Intl., Inc.·Product code LTZ·1997-06-03
K970804 — TRU-PULSE CO2 SURGICAL LASERTissue Technologies, Inc.·Product code GEX·1997-06-03
K970823 — SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETERScimed Life Systems, Inc.·Product code DQY·1997-06-03
K970950 — EASY RODAcromed Corp.·Product code MNH·1997-06-03
K970957 — OSTEONICS RESTORATION ACETABULAR RINGOsteonics Corp.·Product code JDJ·1997-06-03
K971036 — ODONTIT AUTOGENOUS BONE COLLECTION DEVICEInterpore Intl.·Product code GCY·1997-06-03
K971039 — HEMAGEN ANTI CARDIOLIPIN SCREENHemagen Diagnostics, Inc.·Product code MID·1997-06-03
K971063 — OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIRKing Dental Corp.·Product code KLC·1997-06-03
K971114 — BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.·Product code GDM·1997-06-03
K971201 — AUTO SUTURE* ILM** KITUnited States Surgical, A Division of Tyco Healthc·Product code FZP·1997-06-03
K971283 — SYNCHRON SYSTEMS CAL 5 PLUSBeckman Instruments, Inc.·Product code JIX·1997-06-03
K971284 — OPALDAMUltradent Products, Inc.·Product code EIG·1997-06-03
K971411 — DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030KBentec Medical, Inc.·Product code EMX·1997-06-03
K971506 — SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATORBeckman Instruments, Inc.·Product code DMT·1997-06-03
K971513 — COMPOGLASS FIvoclar North America, Inc.·Product code EBF·1997-06-03
K971539 — NOVATIP FAMILY OF LASER HANDPIECE TIPSXanova Corp.·Product code GEX·1997-06-03
K971606 — STERILE FLEXOFILE FILES AND INSTRUMENTSDentsply Intl.·Product code EFA·1997-06-03
K971788 — SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATORBeckman Instruments, Inc.·Product code DHR·1997-06-03
K971911 — LUMAX CYSTOMETRY ADMINISTRATION TUBE SETMedamicus, Inc.·Product code FEN·1997-06-03
K963571 — VYGON MULTI-DOSE VIAL ADAPTER & BIONECTORVygon Corp.·Product code FMI·1997-06-02
K964801 — OPTICAL TRACKING SYSTEM (OTS)Radionics Software Applications, Inc.·Product code HAW·1997-06-02
K964929 — PERIPHERALLY INSERTED CENTRAL CATHETERB.Braun Medical, Inc.·Product code LJS·1997-06-02
K964986 — QUANTA LITE IGA GLIADIN ELISAInova Diagnostics, Inc.·Product code MST·1997-06-02
K970446 — DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEMAlthin Medical AB an Affiliate of Baxter Intl·Product code KDI·1997-06-02
K970767 — CONDOM (RUBBER), LUBRICATED, EXTRA STRENGTHCustom Services Intl., Inc.·Product code HIS·1997-06-02
K970792 — INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICETitan Condoms·Product code HIS·1997-06-02
K970942 — MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEMPhysiometrix, Inc.·Product code GWQ·1997-06-02
K971085 — SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETERB.Braun Medical, Inc.·Product code LJS·1997-06-02
K971517 — SILICONE PUTTY EAR PLUGSBentec Medical, Inc.·Product code EWD·1997-06-02
K971833 — ELECSYS FERRITINBoehringer Mannheim Corp.·Product code JMG·1997-06-02
K951927 — COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)Csen , Ltd.·Product code BSO·1997-05-30
K951928 — DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)Csen , Ltd.·Product code BSP·1997-05-30
K964341 — IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KITImmco Diagnostics, Inc.·Product code MST·1997-05-30
K964344 — IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KITImmco Diagnostics, Inc.·Product code MST·1997-05-30
K964985 — QUANTA LITE IGG GLIADIN ELISAInova Diagnostics, Inc.·Product code MST·1997-05-30
K970491 — DUPEL II BUFFERED IONTOPHORESIS ELECTRODESEmpi·Product code EGJ·1997-05-30
K970824 — MDX 2000, DIGITAL ANALYZERShotwell & Carr, Inc.·Product code JOY·1997-05-30
K971218 — QUIKSTRIP ONE STEP AMPHETAMINE TESTDrial Consultants, Inc.·Product code DKZ·1997-05-30
K971376 — DRIED GRAM-NEGATIVE MIC/COMBO PANELSDade Microscan, Inc.·Product code JWY·1997-05-30
K971691 — LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3Bio-Rad·Product code DIF·1997-05-30
K961229 — HR12000 ULTRASOUND SYSTEMInternational Ultrasound Corp.·Product code IYO·1997-05-29
K962142 — SONOLINE VERSA 555 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc.·Product code IYO·1997-05-29
K963065 — CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERSShantou Institute of Ultrasonic Instuments·Product code IYO·1997-05-29
K963068 — CTS-200 WITH EZU-PL21 TRANSDUCERShantou Institute of Ultrasonic Instuments·Product code IYO·1997-05-29
K963990 — GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIESPhilips Medical Systems, Inc.·Product code LNH·1997-05-29
K964438 — 511 KEV COLLIMATORTrionix Research Laboratory, Inc.·Product code KPS·1997-05-29
K964767 — QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(R&D Systems, Inc.·Product code JZG·1997-05-29
K964791 — B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.·Product code JZG·1997-05-29
K964861 — ACUPUNCTURE NEEDLESC.A.M. Supply, Inc.·Product code MQX·1997-05-29
K970803 — ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGERetractable Technologies, Inc.·Product code MEG·1997-05-29
K970980 — CARDIAC SCORING FOR CT SCANNERSElscint, Inc.·Product code JAK·1997-05-29
K971113 — DMA TRIGLYCERIDES PROCEDURESData Medical Associates, Inc.·Product code CDT·1997-05-29
K971216 — FRIGIDERM FRIGISPRAYDermatologic Lab & Supply, Inc.·Product code GEH·1997-05-29
K971345 — CHOL OR CHOLESTEROLCarolina Liquid Chemistries Corp.·Product code CHH·1997-05-29
K971372 — VARIOLINK IIIvoclar North America, Inc.·Product code EBF·1997-05-29
K971396 — CK REAGENTCarolina Liquid Chemistries Corp.·Product code CGS·1997-05-29
K971403 — SMART - GLOVE POWDER FREE LATEX EXAMINATION GLOVESj Medical Products (M) Sdn Bhd·Product code LYY·1997-05-29
K971454 — TYMPANOSTOMY VENTILATION TUBEIkonos Corp.·Product code ETD·1997-05-29
K971495 — PATHFINDER SUNGLASSESCoil·Product code HQY·1997-05-29
K971748 — TAS PT-NCTEST CONTROLSCardiovascular Diagnostics, Inc.·Product code GGN·1997-05-29
K952545 — WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEMWright Industries·Product code CBF·1997-05-28
K961104 — NOTEBOOK IMAGERDigirad Corp.·Product code IYX·1997-05-28
K964223 — CLINITRON RITE-HITEHill-Rom, Inc.·Product code INX·1997-05-28
K964607 — THERATON 1000ETheratronics, Inc.·Product code IWD·1997-05-28
K964881 — ULTRAVERSE PTA CATHETERVas-Cath, Inc.·Product code LIT·1997-05-28
K970526 — ARTHROCARE MONOPOLAR ELECTROSURGERY LOOPArthrocare Corp.·Product code FAS·1997-05-28
K970685 — EARCHECK PROMdi Instruments, Inc.·Product code ETY·1997-05-28
K970797 — OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIESOlympus America, Inc.·Product code GEI·1997-05-28
K970828 — UHS MICRONET PROGRAMMABLE HEARING AIDS MODELS 901,902,903,906,909/PROGRAMMERUnited Hearing Systems, Inc.·Product code ESD·1997-05-28
K970842 — Cordis Endeavor Infusion CatheterCordis Corp.·Product code QEY·1997-05-28
K971034 — USCI MAINSTAY GUIDING CATHETERC.R. Bard, Inc.·Product code DQO·1997-05-28
K971156 — KASHA VISUAL FIELD SYSTEMKasha Software, Inc.·Product code HPT·1997-05-28
K971480 — DURALASTIC I AND DURALASTIC IIAllied Biomedical Corp.·Product code MIB·1997-05-28
K971544 — SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)Synthes (Usa)·Product code HWE·1997-05-28
K963423 — KSEA CO2 ENDOFLATORKarl Storz Endoscopy·Product code HIF·1997-05-27
K964252 — ORTHOCHUCKBuckman Co., Inc.·Product code GEY·1997-05-27
K964802 — CYBERJET LOCAL ANESTHESIA SYSTEMIntra Vantage, Inc.·Product code EGM·1997-05-27
K970554 — CONVERTORS SMS DRAPESAllegiance Healthcare Corp.·Product code KKX·1997-05-27
K970718 — QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)R&D Systems, Inc.·Product code JNM·1997-05-27
K970776 — LIFECORE O-RING ABUTMENT; LIFECORE DALLA BONA ABUTMENTLifecore Biomedical, Inc.·Product code DZE·1997-05-27
K970786 — ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7)Alexander Mfg. Co.·Product code MRZ·1997-05-27
K970814 — NON-STERILE ISOLATION GOWNAmerican Seal Co.·Product code FYC·1997-05-27
K971202 — COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPSComeg Endoskopie GmbH·Product code OCZ·1997-05-27

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