FDA 510(k) clearances — page 683

176,637 clearances on record, most recent first.

Clearances — page 683

68,201–68,300 of 176,637

K042388 — RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBERadiant Medical·Product code DQY·2004-10-28
K042407 — EMIT CAFFEINE ASSAYDade Behring, Inc.·Product code KLS·2004-10-28
K042810 — CENTURION SES EPIKERATOMENorwood Abbey , Ltd.·Product code HNO·2004-10-28
K042831 — ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER)Reichert, Inc.·Product code IYO·2004-10-28
K042832 — SIENET COSMOS (VERSION V15A)Siemens AG Medical Solutions·Product code LLZ·2004-10-28
K042934 — 1BD SOLOSHOT IX SYRINGEBecton, Dickinson & CO·Product code FMF·2004-10-28
K040170 — FRIADENT PLUS DENTAL IMPLANT SYSTEMSFriadent GmbH·Product code DZE·2004-10-27
K040518 — SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSINGSelect Fabricators, Inc.·Product code FRO·2004-10-27
K040574 — GALILEO GOLDHamilton Medical, Inc.·Product code CBK·2004-10-27
K041669 — VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSDSynovis Surgical Innovations·Product code FTM·2004-10-27
K042077 — BITECH BIPOLAR SCISSORSGuenter Bissinger Medizintechnik GmbH·Product code GEI·2004-10-27
K042161 — ANTI-SNORING/SLEEP APNEA DEVICERj & VK Bird Pty , Ltd.·Product code LRK·2004-10-27
K042183 — GLUCOSE TOLERANCE BEVERAGEEver Scientific·Product code MRV·2004-10-27
K042268 — EBI CAS SPINE SPACER SYSTEMEbi, L.P.·Product code MQP·2004-10-27
K042355 — SYNTHES (USA) LCP WRIST FUSION PLATESSynthes (Usa)·Product code HRS·2004-10-27
K042673 — ZODIAC POLYAXIAL SPINAL FIXATION SYSTEMAlphatec/Nexmed·Product code KWP·2004-10-27
K042833 — SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMSSiemens Medical Solutions USA, Inc.·Product code IYO·2004-10-27
K041102 — IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISAImmco Diagnostics, Inc.·Product code LJM·2004-10-26
K041775 — GE DATEX-OHMEDA ENGSTROM CARESTATIONDatex-Ohmeda, Inc.·Product code CBK·2004-10-26
K042021 — EXACTECH EQUINOXE SHOULDER SYSTEMExactech, Inc.·Product code KWS·2004-10-26
K042034 — NUVASIVE MAXCESS LIGHT GUIDENuvasive, Inc.·Product code FST·2004-10-26
K042048 — GELATO PROPHYLAXIS PASTEDeepak Products, Inc.·Product code EJR·2004-10-26
K042075 — QUILL SYNTHETIC ABSORBABLE BARBED SUTUREQuill Medical, Inc.·Product code NEW·2004-10-26
K042302 — ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLEZoll Medical Corp·Product code LDD·2004-10-26
K042375 — SMK, CX, CXE, RCNTechnomed Europe·Product code GXI·2004-10-26
K042376 — ACUMEN SHEATH, MODEL TTW7807Acumen Medical, Inc.·Product code DYB·2004-10-26
K042435 — COOPER PROSTHETICCooperVision, Inc.·Product code LPL·2004-10-26
K042756 — ENDOREZUltradent Products, Inc.·Product code KIF·2004-10-26
K042802 — H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J & HL168QHealth & Life Co., Ltd.·Product code DXN·2004-10-26
K041149 — GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULEGiven Imaging , Ltd.·Product code NSI·2004-10-25
K041912 — SCB/VALLEYLAB FORCE FX INTERFACE UNITKARL STORZ Endoscopy-America, Inc.·Product code ODA·2004-10-25
K042300 — AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEMApplied Medical Technology, Inc.·Product code KNT·2004-10-25
K042380 — SILICONE BLOCKNational Medical Devices, Inc.·Product code MIB·2004-10-25
K042457 — URO PROW.O.M. World of Medicine AG·Product code LJH·2004-10-25
K040223 — POLYVAC INSTRUMENT DELIVERY SYSTEMSymmetry Medical USA, Inc.·Product code KCT·2004-10-22
K041136 — MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTSBio-Lok Intl., Inc.·Product code DZE·2004-10-22
K041486 — VASOSTASIS VASCULAR CLOSURE SYSTEMCardiva Medical, Inc.·Product code DXC·2004-10-22
K041633 — GYRUS PLASMACISION LAPAROSCOPIC SPATULAGyrus Medical, Inc.·Product code GEI·2004-10-22
K041703 — IPLAN!Brainlab AG·Product code HAW·2004-10-22
K041755 — CROMAX HIGH SPEED TURBINE HANDPIECEJ.R. Medical Technologies, Inc.·Product code EFB·2004-10-22
K042224 — RM3 RENAL PRESERVATION SYSTEMWaters Instruments, Inc.·Product code KDN·2004-10-22
K042357 — IDI-MRSA ASSAYInfectio Diagnostic (I.D.I.), Inc.·Product code NQX·2004-10-22
K042591 — SMARTMIX PRE-FILLED MIXING SYSTEMDePuy Orthopaedics, Inc.·Product code KIH·2004-10-22
K042604 — VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTSValley Forge Scientific Corp.·Product code GEI·2004-10-22
K042698 — UNFORS PATIENT SKIN DOSIMETER (PSD)Unfors, Inc.·Product code JAA·2004-10-22
K042728 — CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEMNovus Monitoring, Ltd.·Product code GWM·2004-10-22
K042799 — QRS-CARD CARDIOLOGY SUITEPulse Biomedical, Inc.·Product code DQK·2004-10-22
K042821 — DIGITAL DETECTOR, MODEL GR17Anrad Corp.·Product code MQB·2004-10-22
K033523 — COLLAGEN-ORC ANTIMICROBIAL MATRIXJohnson & Johnson Medical, Ltd.·Product code FRO·2004-10-21
K041408 — POLYMEDCO OC AUTO MICRO 80 FOB TESTPolymedco, Inc.·Product code OOX·2004-10-21
K042104 — AMERICAN BANTEX, MODEL MS 3American Bantex Corp.·Product code INI·2004-10-21
K042209 — CONTROL PLASMA N AND CONTROL PLASMA PDade Behring, Inc.·Product code GGN·2004-10-21
K042212 — IMPLANTMASTERI-Dent·Product code LLZ·2004-10-21
K042305 — OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903Ossacur AG·Product code MQV·2004-10-21
K042444 — LITESTREAM 500EPride Mobility Products Corp.·Product code IOR·2004-10-21
K042545 — HOVEROUND MPV-5 POWERCHAIRHoveround Corp.·Product code ITI·2004-10-21
K042693 — IV ADMINISTRATION SET B400 SPCodan US Corp.·Product code FPA·2004-10-21
K042779 — RADIOTHERAPY SOLUTION BASED ON CRAgfa Corp.·Product code IXK·2004-10-21
K031832 — MEGA PURE CARTMega Services·Product code FIP·2004-10-20
K041068 — WEST NILE VIRUS IGG INDIRECT ELISAPanbio Limited·Product code NOP·2004-10-20
K041961 — SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEMScandius Biomedical, Inc.·Product code HWC·2004-10-20
K041963 — AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSIAmerican Bantex Corp.·Product code BTT·2004-10-20
K041988 — ARTHROTEK MENISCAL HYBRID DEVICEBiomet, Inc.·Product code JDR·2004-10-20
K042002 — SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADEREla Medical, Inc.·Product code DQK·2004-10-20
K042071 — IBD-SCANTechlab, Inc.·Product code DEG·2004-10-20
K042200 — MI PASTEGC America, Inc.·Product code EJR·2004-10-20
K042369 — SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000Sonoscape Company Limited·Product code IYN·2004-10-20
K042383 — RSA-CMSMedis Medical Imaging Systems BV·Product code LLZ·2004-10-20
K042484 — NAI TECH PRODUCTS MEDICAL DIGITAL RECORDERNai Technology Products·Product code LMA·2004-10-20
K042658 — PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc.·Product code NHA·2004-10-20
K042669 — IONOFIL PLUS ACVoco GmbH·Product code EMA·2004-10-20
K042706 — OSSATURA DENTALIsotis Orthobiologics, Inc.·Product code LYC·2004-10-20
K042708 — ERA 3000 PACING SYSTEM ANALYZERBiotronik, Inc.·Product code DTE·2004-10-20
K042759 — OPTIMA MXBien-Air SA Switzerland·Product code EIA·2004-10-20
K042770 — MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEMSiemens Medical Solutions USA, Inc.·Product code IYN·2004-10-20
K040839 — COMPLETE BLINK-N-CLEAN LENS DROPSAdvanced Medical Optics, Inc.·Product code MRC·2004-10-19
K040866 — FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TESTArmkel, LLC·Product code LCX·2004-10-19
K041969 — AURORA DSSyneron Medical, Ltd.·Product code GEX·2004-10-19
K042031 — OPUS SPEEDSTITCH SUTURE DEVICEOpus Medical, Inc.·Product code GAT·2004-10-19
K042391 — KOLIBRI IMAGE GUIDED SURGERY SYSTEMBrainlab AG·Product code HAW·2004-10-19
K042445 — SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KITBard Access Systems, Inc.·Product code ITX·2004-10-19
K042465 — PS MEDICAL STRATA II VALVEMedtronic Neurosurgery·Product code JXG·2004-10-19
K042492 — HAND STC, MODEL 60MMNiti Medical Technologies , Ltd.·Product code GDW·2004-10-19
K042494 — VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND IIIOrtho-Clinical Diagnostics·Product code CZW·2004-10-19
K042539 — GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COILBoston Scientific Corp·Product code HCG·2004-10-19
K042587 — RETIC-CHEX FOR CELL-DYNStreck Laboratories, Inc.·Product code JPK·2004-10-19
K042646 — DYNACTSiemens Medical Systems, Inc.·Product code IZI·2004-10-19
K042674 — COLON CAR 1.2Medicsight·Product code NWE·2004-10-19
K042740 — ISC-1000 PENTAX CONFOCAL LASER SYSTEMPentax Medical Company·Product code GCJ·2004-10-19
K042741 — EC-3870CILK, CONFOCAL VIDEO COLONOSCOPEPentax Medical Company·Product code GCJ·2004-10-19
K042781 — IPACS CARDIORealtimeimage, Inc.·Product code LLZ·2004-10-19
K033943 — ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODEDCenterpulse Orthopedics, Inc.·Product code KWA·2004-10-18
K034017 — JEJE TEETHERVibe 2000·Product code MEF·2004-10-18
K040485 — MAXAIR SURGICAL HELMET SYSTEMBio-Medical Devices, Inc.·Product code FYA·2004-10-18
K041018 — DRG SOFTRELEASEDoctor'S Research Group, Inc.·Product code HHT·2004-10-18
K041272 — DYRACT CEM PLUS CEMENTDentsply Intl.·Product code EMA·2004-10-18
K042165 — CUTERA TABLETOP AESTHETIC PRODUCTCutera, Inc.·Product code ILY·2004-10-18
K042175 — HEPARINASE HR ACT CONTROL, MODEL 550-12Medtronic Vascular·Product code GGN·2004-10-18
K042206 — PURPLE/BLACK HEPARIN ASSAY CONTROLMedtronic Vascular·Product code GGN·2004-10-18
K042573 — KLS MARTIN DRILL-FREE MMF SCREWKLS-Martin L.P.·Product code DZL·2004-10-18

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