FDA 510(k) clearances — page 1349

176,637 clearances on record, most recent first.

Clearances — page 1349

134,801–134,900 of 176,637

K881961 — MSI STANDARD BED MODELS: L1097-64 AND L1085-64Med Service, Inc.·Product code FNJ·1988-11-01
K882598 — 250 ML BAG W/Y INJECT. & 12 EXTENSION SETPrn Services, Inc.·Product code FRN·1988-11-01
K882949 — TYMPANIC TEMPERATURE SCANNEROmega Medical Corp.·Product code FLL·1988-11-01
K882978 — Q4000 OPTION FOR Q4000Quinton, Inc.·Product code DSI·1988-11-01
K883300 — IRRIGATION SETEdwards Orthopaedics Div., Baxter Healthcare Corp.·Product code HRX·1988-11-01
K883653 — EP-100 INFUSION PUMPStereotactic Medical Systems, Inc.·Product code FRN·1988-11-01
K883688 — ORTHO FACTOR XII DEFICIENT PLASMAOrtho Diagnostic Systems, Inc.·Product code GJT·1988-11-01
K883689 — ORTHO OWREN'S BUFFEROrtho Diagnostic Systems, Inc.·Product code JPA·1988-11-01
K883690 — ORTHO FACTOR X DEFICIENT PLASMAOrtho Diagnostic Systems, Inc.·Product code GJT·1988-11-01
K883691 — ORTHO FACTOR XI DEFICIENT PLASMAOrtho Diagnostic Systems, Inc.·Product code GJT·1988-11-01
K883692 — ORTHO FACTOR VII DEFICIENT PLASMAOrtho Diagnostic Systems, Inc.·Product code GJT·1988-11-01
K883747 — IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIESDiagnostic Products Corp.·Product code CFT·1988-11-01
K883878 — AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)Amersham Corp.·Product code CFT·1988-11-01
K883893 — OMNISOUND(TM) 3000Physio Technology, Inc.·Product code IMG·1988-11-01
K884259 — MODIFIED LANDMARK VENOUS ACCESS DEVICEMenlo Care, Inc.·Product code FOZ·1988-11-01
K884307 — IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262Y·Product code LDR·1988-11-01
K884343 — SONY COLOR VIDEO CAMERAS AND ACCESSORIESSony Corp. of America·Product code FWB·1988-11-01
K884357 — PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEMPrecision Dynamics Corp.·Product code KOT·1988-11-01
K880690 — SIEMENS PACS/I-ASiemens Gammasonics, Inc.·Product code IZI·1988-10-31
K881422 — COE PAK AUTO MIX, REGULAR OR HARD SETCoe Laboratories, Inc.·Product code EMA·1988-10-31
K882048 — MEDITRON ENDOLAV MODEL EL-100Xylog Corp.·Product code KNS·1988-10-31
K882629 — DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KITBd Becton Dickinson Vacutainer Systems Preanalytic·Product code GQG·1988-10-31
K882896 — ONE-STEP HCGWampole Laboratories·Product code DHA·1988-10-31
K883033 — PISTON SYRINGE WITH NEEDLESelect Sources, Inc.·Product code FMF·1988-10-31
K883078 — INSULIN SYRINGESelect Sources, Inc.·Product code FMF·1988-10-31
K883182 — FIAGEN RUBELLA IGGCyberfluor, Inc.·Product code LFX·1988-10-31
K883256 — BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEMBio Clinic Co.·Product code FNM·1988-10-31
K883267 — IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN)Diagnostic Products Corp.·Product code CDZ·1988-10-31
K883337 — PL 20/20 INFANT VISION TESTEROptimed Technologies, Inc.·Product code HOX·1988-10-31
K883408 — NATURALYTE MIXERNational Medical Care, Medical Products Div., Inc.·Product code FIN·1988-10-31
K883432 — IMMUNOCCULT-LXIIntl. Immunoassay Laboratories, Inc.·Product code KHE·1988-10-31
K883539 — SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZERSerono-Baker Diagnostics, Inc.·Product code JJE·1988-10-31
K883635 — KD 0.1 M SODIUM CITRATE SOLUTIONKing Diagnostics, Inc.·Product code JPA·1988-10-31
K883637 — KD 0.02 M CALCIUM CHLORIDE SOLUTIONKing Diagnostics, Inc.·Product code JPA·1988-10-31
K883640 — KD ONE-STAGE PROTHROMBIN TIME TESTKing Diagnostics, Inc.·Product code JPA·1988-10-31
K883646 — BEHRING TURBITIMERBehring Diagnostics, Inc.·Product code JJQ·1988-10-31
K883699 — B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNERFonar Corp.·Product code LNH·1988-10-31
K883765 — TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINEBiotecx Laboratories, Inc.·Product code KHQ·1988-10-31
K883806 — ROCKET INTRAUTERINE SOUNDA & A Medical, Inc.·Product code HHM·1988-10-31
K883844 — HI CHEM KINETIC CHOLESTEROL REAGENT #88218Hichem Diagnostics·Product code CHH·1988-10-31
K883847 — DERATA MEDI-JECTOR VDerata Corp.·Product code KZE·1988-10-31
K883961 — UNIMAX(TM) HEARING AID BTE MODELS:100S, 110C, PPS4Unimax Hearing Instruments·Product code ESD·1988-10-31
K884002 — ANALYST THEOPHYLLINE ROTORThe DU Pont Co.·Product code KLS·1988-10-31
K884053 — PRN PLUS + INFUSION SETPrn Services, Inc.·Product code FPA·1988-10-31
K882345 — PERMANENT PACING LEADS PYBJ SERIESOscor Medical Corp.·Product code DTB·1988-10-28
K882462 — PERMANENT PACING LEAD MODEL RXBJ SERIESOscor Medical Corp.·Product code DTB·1988-10-28
K882682 — COMPAT ENTERAL DELIVERY SYSTEMSandoz Nutrition·Product code KNT·1988-10-28
K882804 — 0.014 PERIPHERAL GUIDE WIREIntensive Technology, Inc.·Product code DQX·1988-10-28
K883058 — SOLCOTRANS ORTHO. DRAINAGE/REINFUSION SYSTEMSolco Basle, Inc.·Product code CAC·1988-10-28
K883314 — PMT 3721-1 EPIDURAL KITProgress Mankind Technology·Product code CAZ·1988-10-28
K883526 — PORGES STEPPED NEOPLEX DILATORPorges Corp.·Product code KNQ·1988-10-28
K883877 — BM-103 BATTERY MODULEDatex Division Instrumentarium Corp.·Product code DQA·1988-10-28
K883908 — 3D VASCULAR RECORDERD. E. Hokanson, Inc.·Product code JOM·1988-10-28
K883916 — ROTATING HEMOSTATIC VALVEDevices For Vascular Intervention, Inc.·Product code DQY·1988-10-28
K883956 — BIO-MEDICUS TUBING CONNECTORSBio Medicus, Inc.·Product code DTL·1988-10-28
K884167 — TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR.Technical Medical Products, Inc.·Product code CBN·1988-10-28
K883187 — SCALP HYDROBATH/TREATMENT DELIVERY SYSTEMIntl. Health Technology, Inc.·Product code ILJ·1988-10-27
K883371 — MULTI-ALLERGEN IGE FASTSCREEN V (T1,T3,T5,T7,T10)3M Company·Product code DHB·1988-10-27
K883746 — MICROMEDIC FERRITIN IRMA KITIcn Micromedic Systems·Product code DBF·1988-10-27
K883881 — MODIFIED MODEL 2001 FIBER OPTICS CATHETERMetatech Corp.·Product code GWM·1988-10-27
K883883 — ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)Immco Diagnostics, Inc.·Product code LKJ·1988-10-27
K883902 — INFUSA-PLATEKalajian Ent.·Product code FRN·1988-10-27
K883907 — SCEPTORPETTE SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic·Product code LRG·1988-10-27
K883949 — ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)Immco Diagnostics, Inc.·Product code LKJ·1988-10-27
K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN GOrion Diagnostica, Inc.·Product code DAH·1988-10-27
K884147 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN MOrion Diagnostica, Inc.·Product code DFT·1988-10-27
K884185 — CIBA CORNING MAGIC LITE TOTAL IGE IMMUNOASSAYCiba Corning Diagnostics Corp.·Product code DHB·1988-10-27
K884311 — MODEL SL60 SURGILASE CO2 SURGICAL LASER SYSTEMSSurgilase, Inc.·Product code GEX·1988-10-27
K884313 — MODEL SL45 SURGILASE CO2 SURGICAL LASER SYSTEMSSurgilase, Inc.·Product code GEX·1988-10-27
K881843 — PEDIATRIC HOSPITAL BEDThe Medical Group, Inc.·Product code IOQ·1988-10-26
K882893 — CONDOMS (RAMSES, SHEIK AND KOROMEX)Schmid Laboratories, Inc.·Product code HIS·1988-10-26
K883192 — SMI 3000 AIRBEDSmi Patientcare, Inc.·Product code IOQ·1988-10-26
K883467 — THE SAXON SPERMICIDAL CONDOMCircle Rubber Corp.·Product code HIS·1988-10-26
K884052 — GILLUM'S WHEELCHAIR WIDTH REDUCING ATTACHMENTProfessional Service Unltd.·Product code KNN·1988-10-26
K884165 — MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYSSpark Instruments & Academics, Inc.·Product code LBB·1988-10-26
K881079 — UVP VOLUMED 2001Ferguson Medical·Product code FRN·1988-10-25
K881264 — PERMA PURE NAFION TUBE DRYER-MODEL MEPerma Pure Products, Inc.·Product code CBQ·1988-10-25
K882059 — BILIRUBIN STANDARDVerichem Laboratories, Inc.·Product code JIT·1988-10-25
K882232 — DISCOVER(R)Carter Products·Product code LCX·1988-10-25
K882428 — REDY 2000Organon Teknika Corp.·Product code FKT·1988-10-25
K882486 — LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND IIBio-Rad·Product code JJY·1988-10-25
K882811 — STREPSLIDENcs Diagnostics, Inc.·Product code GTY·1988-10-25
K883083 — MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEMMedical Diagnostic Technologies, Inc.·Product code GSA·1988-10-25
K883104 — CHEM 1 UIBC (IRON BINDING CAPACITY TEST)Technicon Instruments Corp.·Product code JMO·1988-10-25
K883173 — MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATIONKARL STORZ Endoscopy-America, Inc.·Product code OCX·1988-10-25
K883266 — FDL ELISA FOR CHLAMYDIAFairleigh Dickinson Laboratories, Inc.·Product code LJC·1988-10-25
K883321 — CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TESTHeraeus Kulzer, Inc.·Product code JJE·1988-10-25
K883390 — PMD SYSTEM-20Datatek, Inc.·Product code KMI·1988-10-25
K883403 — DENTA PLUSConnoisseurs Products Corp.·Product code JER·1988-10-25
K883453 — ROCHE REAGENT FOR CALCIUMRoche Diagnostic Systems, Inc.·Product code CJY·1988-10-25
K883479 — STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYMEBaxter Healthcare Corp·Product code CDP·1988-10-25
K883489 — KRATZ NOVA SERT(TM)Coopervision-Cilco·Product code KYB·1988-10-25
K883525 — OXALATE REAGENTSigma Chemical Co.·Product code LPW·1988-10-25
K883560 — CDT CYTOTOXI TESTAdvanced Clinical Diagnostics·Product code LLH·1988-10-25
K883605 — MODIFIED REUSABLE SITE FIBER OPTIC CABLESite Microsurgical Systems, Inc.·Product code HQE·1988-10-25
K883658 — I-SPOSE EYE SHIELDProducts For Medicine·Product code FXX·1988-10-25
K883778 — RUBELLA IGM MICROASSAYDiamedix Corp.·Product code LFX·1988-10-25
K883830 — FIBER OPTIC LARYNGOSCOPEEffner, Inc.·Product code CCW·1988-10-25
K883971 — QLIA T UPTAKE ASSAYBd Becton Dickinson Vacutainer Systems Preanalytic·Product code CEC·1988-10-25
K883975 — DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI.Site Microsurgical Systems, Inc.·Product code HQE·1988-10-25

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