FDA 510(k) clearances — page 969

176,637 clearances on record, most recent first.

Clearances — page 969

96,801–96,900 of 176,637

K960982 — MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULASherwood Medical Co.·Product code FMI·1996-12-23
K961601 — H.A.M. APPLICATORMick Radio-Nuclear Instruments, Inc.·Product code JAQ·1996-12-23
K962093 — ULTRAMIXSonotech, Inc.·Product code ITX·1996-12-23
K962138 — FLEXART V3.1 SOFTWAREToshiba America Mri, Inc.·Product code LNH·1996-12-23
K962226 — PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEMJohnson & Johnson Medical, Inc.·Product code FOZ·1996-12-23
K962840 — ECOLOTION TRANSMISSION AND MASSAGE LOTIONEco-Med Pharmaceuticals, Inc.·Product code ITX·1996-12-23
K962976 — PHARMACIA CAP SYSTEM RAST FEIAPharmacia & Upjohn Co.·Product code DHB·1996-12-23
K963111 — COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V SChromogenix AB·Product code GGW·1996-12-23
K963699 — BELRAY/MODEL 096, DENTAL INTRAORAL X-RAYBelmont Equipment Corp.·Product code EHD·1996-12-23
K963762 — CORNEAL TOPOGRAPHER 200Eclipse Ventures·Product code MMQ·1996-12-23
K963795 — VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATHVision-Sciences, Inc.·Product code EOQ·1996-12-23
K963860 — THE NOMOS TALON POSITIONING AND IMMOBILIZATION SYSTEMNomos Corp.·Product code IYE·1996-12-23
K963952 — SERIES 9600 MOBILE DIGITAL IMAGING SYSTEMGe Dec Medical Systems·Product code OWB·1996-12-23
K963980 — PHILIPS EASYVISIONPhilips Medical Systems North America, Inc.·Product code LLZ·1996-12-23
K964031 — DCL8 ENHANCED PULSED ND:YAG LASER SYSTEMSlt-J , Ltd.·Product code GEX·1996-12-23
K964125 — CONVERTORS DRAPE MATERIALAllegiance Healthcare Corp.·Product code KKX·1996-12-23
K964196 — CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)Northgate Technologies, Inc.·Product code OCX·1996-12-23
K964376 — CIDE-SWIPES P-100B & CIDE-SWIPES C-100AMp Scientific, Inc.·Product code LRJ·1996-12-23
K964453 — REP 3 FLUR SPE-60 KITHelena Laboratories·Product code CEF·1996-12-23
K964471 — REP FLUR CHOLESTEROL-60 KITHelena Laboratories·Product code JHO·1996-12-23
K964618 — CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1Coulter Corp.·Product code GKZ·1996-12-23
K964659 — ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEMDentsply Intl.·Product code EHD·1996-12-23
K964794 — DAHLBERG K-AMP BTEMiracle-Ear, Inc.·Product code ESD·1996-12-23
K952721 — RUBASCAN CARD TESTBd Becton Dickinson Vacutainer Systems Preanalytic·Product code LFX·1996-12-20
K953269 — SAFECIRCUIT MANIFOLD/PULMONARY UNITAdvanced Warming Systems, Inc.·Product code CBN·1996-12-20
K955265 — CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETERCordis Corp.·Product code JXG·1996-12-20
K955324 — BIPAP S/T-D 30 SYSTEMRespironics, Inc.·Product code MNT·1996-12-20
K961013 — DISPOSABLE NEEDLE ELECTRODEMedelec Intl. Corp.·Product code IKT·1996-12-20
K962148 — VERGE VIDEOMETERVerg, Inc.·Product code FXN·1996-12-20
K962424 — NPB-4000Analogic Corp.·Product code MHX·1996-12-20
K962474 — OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY)Olympus America, Inc.·Product code FBO·1996-12-20
K962928 — COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)Camino Neurocare, Inc.·Product code GWM·1996-12-20
K963417 — VITLITE (TR7700)Escalon Trek Medical·Product code MPA·1996-12-20
K963825 — AUTO SUTURE* ABBI* SYSTEMUnited States Surgical, A Division of Tyco Healthc·Product code KNW·1996-12-20
K963837 — HORIZON/WESTHIN 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANWestcon Contact Lens Co., Inc.·Product code LPL·1996-12-20
K963960 — KSEA UNIMAT PLUSKARL STORZ Endoscopy-America, Inc.·Product code HET·1996-12-20
K964215 — ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEMSmith & Nephew Endoscopy, Inc.·Product code HRX·1996-12-20
K964222 — ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANINGPaladin Medical, Inc.·Product code LYL·1996-12-20
K964443 — SURGIFORM ANATOMICAL MALARSurgical Technology Laboratories, Inc.·Product code LZK·1996-12-20
K964519 — CURITY THORACENTESIS TRAYKendall Healthcare Products Co. Div.Of Tyco Health·Product code GCX·1996-12-20
K964621 — A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTONAlto Development Corp.·Product code GEI·1996-12-20
K964774 — PUNCTUM PLUGS & READY-SET PUNCTAL PLUGSFci Ophthalmics, Inc.·Product code LZU·1996-12-20
K964788 — EL DORADO 55Gateway Alloys, Inc.·Product code EJT·1996-12-20
K964789 — LA PLATA 39Gateway Alloys, Inc.·Product code EJT·1996-12-20
K964792 — LA PLATA 40Gateway Alloys, Inc.·Product code EJT·1996-12-20
K964837 — PACIFIC 56 (CB-40)Gateway Alloys, Inc.·Product code EJT·1996-12-20
K964838 — PALLADIA 85 (PM-13)Gateway Alloys, Inc.·Product code EJT·1996-12-20
K945410 — IRT LOCKING SYRINGEInterventional Research Technologies·Product code FMF·1996-12-19
K962139 — SAFESKINSafeskin Corp.·Product code LZA·1996-12-19
K962518 — NITRILE COPOLYMER PATIENT EXAMINATION GLOVESP.T. Irama Dinamika Latex·Product code LZA·1996-12-19
K963465 — PELVIC HOLDERDeroyal Industries, Inc.·Product code FMQ·1996-12-19
K963771 — CHLOROPRENE EXAM GLOVESP.T. Irama Dinamika Latex·Product code LZA·1996-12-19
K963949 — KSEA UNIMAT PLUSKARL STORZ Endoscopy-America, Inc.·Product code HET·1996-12-19
K963959 — OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION)Osteonics Corp.·Product code MEH·1996-12-19
K964059 — MICADENTHampton Research·Product code KOJ·1996-12-19
K964828 — VIREX II 128 GERMICIDAL CLEANER AND DEODORANTS.C. Johnson & Son, Inc.·Product code LRJ·1996-12-19
K960839 — FILM SCANNER 300Cannon U.S.A., Inc.·Product code LMA·1996-12-18
K962049 — C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KITPolymedco, Inc.·Product code DCK·1996-12-18
K962583 — CAT SCOOTER WITH DS60 VONYTOLLRTInvacare Respiratory Corp.·Product code INI·1996-12-18
K962864 — THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERSAlko Diagnostic Corp.·Product code KRZ·1996-12-18
K963228 — REPLIDERM WOUND DRESSINGOrphan Medical, Inc.·Product code KGN·1996-12-18
K963641 — STREPTOCOCCUS MIC PANELDade Microscan, Inc.·Product code JWY·1996-12-18
K963807 — TOMTEC ECHO-SCANTomtec Imaging Systems, Inc.·Product code IYO·1996-12-18
K963826 — ENDOCARE CRYCARE CRYOSURGICAL SYSTEMEndocare, Inc.·Product code GEH·1996-12-18
K963859 — QLVA PLUSSanders Data Systems, LLC·Product code LLZ·1996-12-18
K963861 — LASERSHARE PRINT SPOOLER AND/OR SOFTWAREDejarnette Research Systems·Product code LMD·1996-12-18
K963888 — C-ARM TABLE IVS-100Shimadzu Medical Systems·Product code JAA·1996-12-18
K963896 — MOBILE CT PROSPEED FAMILYGE Medical Systems·Product code JAK·1996-12-18
K963939 — SYNERMED DIRECT BILIRUBIN REAGENT KITSynermed, Inc.·Product code CIG·1996-12-18
K963953 — IMIG-MRIImig-Mri Systems, LLC·Product code LNH·1996-12-18
K964072 — MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYEDETHICON, Inc.·Product code GAN·1996-12-18
K964124 — PHILIPS COMPUTED RADIOGRAPHYPhilips Medical Systems, Inc.·Product code LLZ·1996-12-18
K964203 — PIPERACILLIN/TAZOBACTAM 4Ab Biodisk·Product code JWY·1996-12-18
K964212 — QUINIDINE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.·Product code LBZ·1996-12-18
K964250 — LINX NETWORKING SYSTEMSterling Diagnostic Imaging, Inc.·Product code LMD·1996-12-18
K964270 — UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMAUniversal Reagents, Inc.·Product code GGP·1996-12-18
K964442 — VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEMBayer Corp.·Product code LEG·1996-12-18
K964459 — UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMAUniversal Reagents, Inc.·Product code GGP·1996-12-18
K964721 — VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)Johnson & Johnson Clinical Diagnostics, Inc.·Product code KLI·1996-12-18
K954642 — HYDRO-SELECT GUIDEWIREMicrovena Corp.·Product code DQX·1996-12-17
K955791 — SURGIFLATOR-20 PIMW.O.M. World of Medicine GmbH·Product code HIF·1996-12-17
K961318 — 1ST RESPONSE DISPOSABLE MANOMETERIntertech Resources, Inc.·Product code CAP·1996-12-17
K962185 — HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENSCooperVision, Inc.·Product code LPL·1996-12-17
K962538 — BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06)C.R. Bard, Inc.·Product code FAS·1996-12-17
K962572 — SCIMED CHOICE PT VISION PTCA GUIDE WIREScimed Life Systems, Inc.·Product code DQX·1996-12-17
K962894 — SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEMSynthes (Usa)·Product code HRS·1996-12-17
K963307 — GDC PATIENT RETURN ELECTTRODE MODEL 45021Target Therapeutics·Product code HCG·1996-12-17
K963749 — HIGH PRESSURE INJECTION LINESMaxxim Medical·Product code DTL·1996-12-17
K963993 — RUSCH SIMPLASTIC FOLEY CATHETERIZATION SETRusch, Inc.·Product code FCM·1996-12-17
K964289 — EYE FIXATION SPECULUMEyefix, Inc.·Product code HNC·1996-12-17
K964316 — PLASTIC SUNGLASSESMedical Reports Exchange, Inc.·Product code HQY·1996-12-17
K964554 — PERSONAL TELEMEDICINE MODULEAmerican Telecare, Inc.·Product code DRG·1996-12-17
K954610 — MODEL 430-07 ENDOCARDIAL PACING LEADIntermedics, Inc.·Product code DTB·1996-12-16
K960101 — ISLAND BIOSURGICAL BOLSTERIsland Biosurgical, Inc.·Product code OTN·1996-12-16
K960643 — ADVANTAGE MAPF HIP FEMORAL COMPONENTBiomet, Inc.·Product code KWY·1996-12-16
K961859 — NOVUS STANDARD AND PEDIATRIC VALVESIntegra Neurocare, LLC·Product code JXG·1996-12-16
K962050 — THERATEST EL-RFSCRTheratest Laboratories, Inc.·Product code DHR·1996-12-16
K962230 — CELSITE PORT WITH PRECONNECTED CATHETERB.Braun Medical, Inc.·Product code LJT·1996-12-16
K962283 — EEG ELECTRODESTeca, Inc.·Product code GXY·1996-12-16
K962296 — STREPTOLEX-STATUnipath , Ltd.·Product code GTZ·1996-12-16

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