FDA 510(k) clearances — page 1433

176,637 clearances on record, most recent first.

Clearances — page 1433

143,201–143,300 of 176,637

K864083 — GAMBRO BICARBONATE MONITOR BCM 10-2Gambro, Inc.·Product code FKP·1986-11-06
K864167 — PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED)Datascope Corp.·1986-11-06
K864169 — FRESENIUS HEMOFLOW F50 & F70Seratronics, Inc.·Product code KDI·1986-11-06
K861211 — MONO ACU-SLIDE TESTCal-Tech Diagnostics, Inc.·Product code JHJ·1986-11-05
K861425 — SUB-VENT (TM) IMPLANT/ENDOSSEOUS BLADE IMPLANTCore-Vent Corp.·Product code DZE·1986-11-05
K862421 — SERUM CLONAZEPAM TOXICOLOGY CONTROLUtak Laboratories, Inc.·Product code LAS·1986-11-05
K862946 — OXOID SIGNAL BLOOD CULTURE SYSTEMOxoid U.S.A., Inc.·Product code JSG·1986-11-05
K862984 — UNIDEX GLUCOSE TEST STRIPUnidex, Inc.·Product code CGA·1986-11-05
K863475 — THEOFAST(TM) TEST PACKAGE3M Company·Product code LER·1986-11-05
K863490 — ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORTOrtho Diagnostic Systems, Inc.·Product code LJC·1986-11-05
K863521 — LYTENING 2Amdev, Inc.·Product code JGS·1986-11-05
K863738 — EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95Em Diagnostic Systems, Inc.·Product code CGX·1986-11-05
K863744 — HCG CONTROL KITMonoclonal Antibodies, Inc.·Product code JJX·1986-11-05
K863802 — VMAX KINETIC MICROPLATE READERMolecular Devices Corp.·Product code JJQ·1986-11-05
K863840 — METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEME.I. Dupont DE Nemours & Co., Inc.·Product code JJE·1986-11-05
K863887 — SMI MULTIPETTOR(TM)American Dade·Product code JQW·1986-11-05
K863888 — DU PONT PHENYTOIN ASSAY AND CALIBRATORE.I. Dupont DE Nemours & Co., Inc.·Product code DIR·1986-11-05
K864097 — WIDEX HEARING AID MODEL ES2Widex Hearing Aid Co., Inc.·Product code ESD·1986-11-05
K864102 — LIGACLIP 20/20* MULTIPLE CLIP APPLIERETHICON, Inc.·Product code FZP·1986-11-05
K864139 — RANFAC CUT BIOPSY NEEDLERanfac, Corp.·Product code GAA·1986-11-05
K864146 — DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE)Cardio Thoracic Systems·Product code GDW·1986-11-05
K864175 — SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHESFraass Survival Systems, Inc.·Product code EFQ·1986-11-05
K864180 — INTEGRA, CUSTOM IN-THE-EAR HEARING AIDBernafon, Inc.·Product code ESD·1986-11-05
K855233 — DIAGNOSTIC REAGENT SET-RPLAOxoid U.S.A., Inc.·Product code GTN·1986-11-04
K855234 — DIAGNOSTIC REAGENT VET-RPLAOxoid U.S.A., Inc.·Product code GNA·1986-11-04
K855235 — DIAGNOSTIC REAGENT PET-RPLAOxoid U.S.A., Inc.·Product code JSP·1986-11-04
K855236 — DIAGNOSTIC REAGENT TST-RPLAOxoid U.S.A., Inc.·Product code GTN·1986-11-04
K862059 — SHEATH, ENDOSCOPEEndovations·Product code FGE·1986-11-04
K862164 — EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNERHitachi Medical Corp. of America·Product code IYO·1986-11-04
K862855 — CRAIG NASO-GASTRIC TUBE HOLDERHenley Intl.·Product code KNT·1986-11-04
K862913 — CARDIOSCAN WITH DOPPLER OPTIONInterspec, Inc.·Product code JOP·1986-11-04
K863172 — RESPIRONICS PTL REVIVEEASYRespironics, Inc.·Product code CAO·1986-11-04
K863273 — MARTIN MEDICAL PRO-SCOPE ANOSCOPEMartin Medical·Product code KOA·1986-11-04
K863354 — BIO-GUARD AB COATED CATHETERCook Urological, Inc.·Product code KOD·1986-11-04
K863372 — SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBESInterspec, Inc.·Product code DPT·1986-11-04
K863385 — (ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLECook Urological, Inc.·Product code KNN·1986-11-04
K863571 — BILIARY BALLOON CATHETERUresil Corp.·Product code FGE·1986-11-04
K863937 — OSRAM ULTRAMED 400 WOsram GmbH·Product code FTC·1986-11-04
K863958 — TUBEGRIPPER, UROLOGICAL CATHETER & ACCESSORYCathaid, Inc.·Product code KOD·1986-11-04
K863996 — MODEL XE-103 XENON/MASTER IIMedi Nuclear Corp., Inc.·Product code IYT·1986-11-04
K864044 — ESOPHAGEAL/RECTAL TEMPERATURE PROBE W/TYPE TRespiratory Support Products, Inc.·Product code FLL·1986-11-04
K864176 — GENTLE FEELMali, Inc.·Product code HFS·1986-11-04
K862190 — WALRUS: DOUBLE BALLOON SHUNTING CATHETERMedical Parameters, Inc.·Product code DWF·1986-11-03
K862260 — EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLSSyva Co.·Product code LCD·1986-11-03
K862436 — TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)Acutronic Medical Systems AG·Product code BTO·1986-11-03
K862875 — E-VAC(TM)Laerdal California, Inc.·Product code BTA·1986-11-03
K863353 — MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)Grason-Stadler, Inc.·Product code ETY·1986-11-03
K863421 — SR-IVOLEN TRAY MATERIALIvoclar USA, Inc.·Product code EBH·1986-11-03
K863635 — UPDATED STERILE ENDOTRACHEAL BRUSHESBiological & Environmental Control Laboratories·Product code EPE·1986-11-03
K863675 — CALIBRATION GAS FOR SERVO GAS MONITOR 120Siemens Elema AB·Product code BXK·1986-11-03
K863781 — MODEL 493-08 POLYFLEX ENDOCARDIAL LEADIntermedics, Inc.·Product code DTB·1986-11-03
K863858 — TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE--Hybritech, Inc.·Product code DGC·1986-11-03
K864047 — MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTERIntermedics, Inc.·Product code DTB·1986-11-03
K864048 — MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTERIntermedics, Inc.·Product code DTB·1986-11-03
K864088 — HITACHI HAND HELD MASSAGER A/C POWEREDHitachi Sales Corporation of America·Product code ISA·1986-11-03
K864117 — SUPPORT ARMLeonard Medical, Inc.·1986-11-03
K864141 — CORDIS CONTRAST INJECTION LINESCordis Corp.·Product code DQO·1986-11-03
K864162 — DEGUPALDegussa Dental, Inc.·Product code EJS·1986-11-03
K864181 — SOMATICS MOUTH GUARD (BITE BLOCK)Somatics, Inc.·Product code JXL·1986-11-03
K862451 — LUER LOCK SKIRTHewlett-Packard Co.·Product code DTL·1986-10-31
K862634 — TDMAC-HEPARIN COATED RMI CAROTID BY-PASS SHUNTResearch Medical, Inc.·Product code DWF·1986-10-31
K862740 — QUINTON Q.CATHQuinton, Inc.·Product code DQK·1986-10-31
K862742 — NEPHROSTOMY SETMeadox Surgimed, Inc.·Product code LJE·1986-10-31
K862911 — BI-PLANE TRANSRECTAL PROBE NUMBER H4221TGeneral Electric Co.·Product code ITX·1986-10-31
K862949 — HATCHER STONE EXTRACTOR - DISPOSABLE CATHETEROscor Medical Corp.·Product code LQR·1986-10-31
K862966 — 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1)Oscor Medical Corp.·Product code DTB·1986-10-31
K863040 — DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGSCher Mel Corp.·Product code KPE·1986-10-31
K863246 — MIRALITEMira, Inc.·Product code HQF·1986-10-31
K863281 — CARE + PLUS IRREGATION TRAYWelmed Systems, Inc.·Product code KOD·1986-10-31
K863282 — CARE + PLUS CATHETER CARE TRAYWelmed Systems, Inc.·Product code KOD·1986-10-31
K863404 — CARDIOLIFE TEC 7100Nihon Kohden America, Inc.·Product code LDD·1986-10-31
K863405 — CARDIOLIFE TEC 7200Nihon Kohden America, Inc.·Product code LDD·1986-10-31
K863444 — GRIESHABER GLOBAL CONTROL TUBING SETGrieshaber & Co.·Product code HQC·1986-10-31
K863517 — FOLEY CATHETERSInstrumentation Industries, Inc.·Product code KOD·1986-10-31
K863537 — CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTYCordis Corp.·Product code DXT·1986-10-31
K863547 — MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLEMedtronic Vascular·Product code DRO·1986-10-31
K863581 — MODIFIED MODEL 5320 T.E.D. COMPRESSION LIMBThe Kendal Co.·Product code JOW·1986-10-31
K863725 — CATARACT DIAMOND KNIFEMedical Technology Development Corp.·Product code HNN·1986-10-31
K863727 — FIXATION INSTRUMENTSMedical Technology Development Corp.·Product code HNR·1986-10-31
K863728 — THE ERGOSYSTEM CHAIRCharles D. Bell, Inc.·Product code HME·1986-10-31
K863986 — XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURESAmerican Edwards Laboratories·Product code HRX·1986-10-31
K863988 — THORTON TITANIUM HOOK ANGLED RIGHTKeeler Instruments, Inc.·Product code HNQ·1986-10-31
K863989 — THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)Keeler Instruments, Inc.·Product code HNC·1986-10-31
K863990 — THORNTON TITANIUM SILVER SPATULAKeeler Instruments, Inc.·Product code HND·1986-10-31
K863991 — THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STANDKeeler Instruments, Inc.·Product code HNR·1986-10-31
K863992 — THORNTON TITANIUM FORCEPS (VARIOUS TYPES)Keeler Instruments, Inc.·Product code HNR·1986-10-31
K863993 — VTS REPORTER OR VTS LINKSensory Aids Corp.·Product code HPF·1986-10-31
K863994 — VIEWSCANSensory Aids Corp.·Product code HOT·1986-10-31
K864003 — PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPSAllergan, Inc.·Product code HNR·1986-10-31
K864056 — GRIESHABER AIR SYSTEM/PRESSURE OPHTHALMIC IRRIGANTGrieshaber & Co.·Product code HQC·1986-10-31
K864077 — CANDIDA BROM CRESOL GREEN AGARBd Becton Dickinson Vacutainer Systems Preanalytic·Product code JSI·1986-10-31
K864078 — MODIFIED N.Y.C. FERMENTATION MEDIUM BASEBd Becton Dickinson Vacutainer Systems Preanalytic·Product code JTY·1986-10-31
K864100 — TRYCOPHYTON AGARSBd Becton Dickinson Vacutainer Systems Preanalytic·Product code JSH·1986-10-31
K862385 — SCHEIN BLEACHING UNITHenry Schein, Inc.·Product code EEG·1986-10-30
K862950 — WHITE-SIPOSS TUBE, CAT NO WS-1American Omni Medical, Inc.·Product code BTR·1986-10-30
K863207 — OHMEDA 'B' SERIES GAS DELIVERY SYSTEMOhmeda Medical·Product code BSZ·1986-10-30
K863243 — SHINER STRESS DIRECTING ATTACHMENTJs & R - R & D Co.·Product code EGG·1986-10-30
K863411 — GUTTA PERCHAEndodent, Inc.·Product code EKM·1986-10-30
K863638 — GUTTA PERCHA POINTSEndodent, Inc.·Product code EKM·1986-10-30
K863753 — FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000Foundations Plus, Inc.·Product code KGX·1986-10-30

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