FDA 510(k) clearances — page 424

176,542 clearances on record, most recent first.

Clearances — page 424

42,301–42,400 of 176,542

K122560 — VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1Pan-America Hyperbarics, Inc.·Product code CBK·2013-03-26
K123118 — INSIGNIA DIGICASTOrmco Corp.·Product code DYW·2013-03-26
K123743 — ULTRASAFE PLUS PASSIVE NEEDLE GUARDSafety Syringes, Inc.·Product code MEG·2013-03-26
K123976 — NOBELCLINICIANNobel Biocare AB·Product code LLZ·2013-03-26
K130415 — HIGH METABOLITE QUALICHECKRadiometer Medical Aps·Product code JJS·2013-03-26
K130671 — VENACURE EVLT NEVERTOUCH PROCEDURE KITAngioDynamics, Inc.·Product code GEX·2013-03-26
K113871 — PRO-DENSE BONE GRAFT SUBSTITUTEWrightmedicaltechnologyinc·Product code MQV·2013-03-25
K123665 — LIFELINES IEEGKvikna Ehf·Product code OLT·2013-03-25
K123745 — SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAILBiomecanica Industria E Comerico DE Productos Orto·Product code HSB·2013-03-25
K124059 — AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)Lauer Membran Wassertechnik GmbH·Product code FIP·2013-03-25
K130173 — SONOSITE MAXX SERIES ULTRASOUND SYSTEMFUJIFILM Sonosite, Inc.·Product code IYN·2013-03-25
K130396 — RAMPART O AND RAMPART PSpineology, Inc.·Product code MAX·2013-03-25
K130754 — ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medi Cal Solutions, Inc.·Product code IYN·2013-03-25
K122584 — HEMOSIL READIPLAS TINInstrumentation Laboratory CO·Product code GJS·2013-03-24
K123618 — AXERA 2 ACCESS SYSTEMArstasis, Inc.·Product code DYB·2013-03-24
K130164 — FIBERLASE ENDURE CO2 FIBERLumenis, Ltd.·Product code GEX·2013-03-24
K120771 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMBeckman Coulter, Inc.·Product code GKZ·2013-03-22
K121247 — ALCO-SCREENChematics, Inc.·Product code DIC·2013-03-22
K121946 — AXIS-SHIELD ACVTIVE-B12Axis-Shield Diagnostics, Ltd.·Product code CDD·2013-03-22
K122037 — ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPSTMedtronic Sofamor Danek, Inc.·Product code MAX·2013-03-22
K122253 — PROCARE MONITOR B20Ge Medical Systems China Co., Ltd.·Product code MHX·2013-03-22
K122456 — MRII CRAINIAL DRILLMri Interventions, Inc.·Product code HBG·2013-03-22
K123013 — ENDOSCOPIC INTRODUCERNovadaq Technologies, Inc.·Product code FED·2013-03-22
K123303 — FEMORAL ACCESS VENOUS CANNULAEEdwards Lifesciences, LLC·Product code DWF·2013-03-22
K123457 — BALANCED KNEE SYSTEM HIGH FLEX PSOrtho Development Corp.·Product code JWH·2013-03-22
K123556 — MORTARA SURVEYOR PATIENT MONITORMortara Instrument, Inc.·Product code MHX·2013-03-22
K123587 — HEINE MINI 3000 LED OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KG·Product code HLJ·2013-03-22
K123652 — SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICESpineology, Inc.·Product code MAX·2013-03-22
K124004 — NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPSMedtronic Navigation, Inc.·Product code OLO·2013-03-22
K130009 — VARIAX 2 COMPRESSION PLATING SYSTEMStryker Trauma AG·Product code HRS·2013-03-22
K130141 — S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)Hitachi Chemical Diagnostics, Inc.·Product code CJE·2013-03-22
K130276 — DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.·Product code JJE·2013-03-22
K130596 — CAIMAN SEAL AND CUT TECHNOLOGYAesculap, Inc.·Product code GEI·2013-03-22
K113727 — SHENZHEN MED-LINK PULSE OXIMETER PROBEShenzhen Med-Link Electronics Tech Co., Ltd.·Product code DQA·2013-03-21
K120354 — BETA-TCP GRANULESSkeletal Kinetics, LLC·Product code MQV·2013-03-21
K121772 — ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1Philips Medical Systems Nederland B.V.·Product code OWB·2013-03-21
K121894 — XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIXLuminex Molecular Diagnostics, Inc.·Product code PCH·2013-03-21
K121979 — PASS OCT SPINAL SYSTEMMedicrea International·Product code KWP·2013-03-21
K121981 — ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAYSiemens Healthcare Diagnostics·Product code CEW·2013-03-21
K122060 — CLEVER TD-7001NEBULIZERTaidoc Technology Corporation·Product code CAF·2013-03-21
K122098 — APPS-HEALTH01Andon Health Co, Ltd.·Product code DXN·2013-03-21
K122206 — GARAVENTA X3 INCLINED PLATFORM LIFTGaraventa (Canada) Ltd [Dba Garaventa Lift]·Product code PCE·2013-03-21
K122218 — ADVANCE TOTAL KNEE SYSTEM-PATELLAWrightmedicaltechnologyinc·Product code MBH·2013-03-21
K123335 — SUNRAY FETAL MONITORSunray Medical Apparatus Co., Ltd.·Product code HGM·2013-03-21
K123498 — BP652N (HEM-6300-Z)Omron Healthcare, Inc.·Product code DXN·2013-03-21
K123511 — S9 VPAP TXResmed, Ltd.·Product code MNS·2013-03-21
K130112 — CAPNO MODULE, 92517Spacelabs Healthcare·Product code CCK·2013-03-21
K130221 — HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEMMedimecca Co., Ltd.·Product code DZE·2013-03-21
K130344 — DORNIER MEDILAS UROPULSEDornier Medtech America, Inc.·Product code GEX·2013-03-21
K130413 — PINPOINTE FOOTLASERNuvolase, Inc.·Product code GEX·2013-03-21
K130609 — VEEDA 100% COTTON MENSTRUAL TAMPONNaturalena Brands, Inc.·Product code HEB·2013-03-21
K130619 — ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc.·Product code IYN·2013-03-21
K120782 — INTERVENTIONAL HEMOSTATIC BANDAGEZ-Medica Corporation·Product code QSY·2013-03-20
K121655 — BD ALCOHOL SWABBecton, Dickinson & CO·Product code LKB·2013-03-20
K122160 — VANGUARD XP KNEE SYSTEMBiomet Manufacturing Corp·Product code MBH·2013-03-20
K122247 — LIDCORAPID V2 MONITORLidco, Ltd.·Product code DXG·2013-03-20
K123403 — AXSOS PROXIMAL LATERAL TIBIA LONG PLATESStryker Trauma AG·Product code HRS·2013-03-20
K123468 — DEMI ULTRAKerr Corporation·Product code EBZ·2013-03-20
K123640 — TX1 TISSUE REMOVAL SYSTEMTenex Health·Product code LFL·2013-03-20
K123687 — OPTETRAK LOGIC POROUS FEMORAL COMPONENTExactech, Inc.·Product code JWH·2013-03-20
K123805 — E-Z CHEK BLOOD LEAK TEST STRIPSReprocessing Products Corp·Product code FJD·2013-03-20
K123832 — OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGMEThe Orthopaedic Implant Company (Oic)·Product code HRS·2013-03-20
K123952 — CEREC BLOCS C INSirona Dental Systems GmbH·Product code EIH·2013-03-20
K130206 — PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUSPentax of America, Inc.·Product code ODG·2013-03-20
K130228 — SUITEHEARTNeosoft, LLC·Product code LLZ·2013-03-20
K130229 — PALM BLADDER SCANNERMianyang Meike Electronic Equipment Co., Ltd.·Product code IYO·2013-03-20
K130247 — PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUSPentax of America, Inc.·Product code ODG·2013-03-20
K130252 — CPS AIM UNIVERSAL SLITTABLE INNER CATHETERSt Jude Medical·Product code DQY·2013-03-20
K130257 — CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETERSt Jude Medical·Product code DQY·2013-03-20
K130393 — MIRADA RTXMirada Medical, Ltd.·Product code LLZ·2013-03-20
K130433 — INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATESorin Group Italia S.R.L.·Product code DTZ·2013-03-20
K122220 — ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC SSoflex Limited·Product code LPL·2013-03-19
K122522 — DENTOETCH QUICKBOND BOND ACTIVATORItena Clinical·Product code KLE·2013-03-19
K122940 — ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3Cook, Inc.·Product code DQY·2013-03-19
K123208 — DIGITAL RETINAL CAMERACanon Inc. -Medical Equipment Group·Product code HKI·2013-03-19
K123330 — IOGYN ENDOSCOPEIogyn, Inc.·Product code HIH·2013-03-19
K123351 — AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACEMedtronic Perfusion Systems·Product code DTM·2013-03-19
K123415 — BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPEREDBiodenta Swiss AG·Product code DZE·2013-03-19
K123477 — VIA MICROCATHETER, VIA PLUS MICROCATHETERSequent Medical, Inc.·Product code KRA·2013-03-19
K123589 — CADWELL DISPOSABLE PROBE HANDLECadwell·Product code PDQ·2013-03-19
K123765 — GUIDEZILLA GUIDE EXTENSION CATHETERBoston Scientific·Product code DQY·2013-03-19
K130157 — AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SETAalto Scientific, Ltd.·Product code JJX·2013-03-19
K130468 — ORBIT INFUSION SETYpsomed AG·Product code FPA·2013-03-19
K122059 — ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORSSmith & Nephew, Inc.·Product code MBI·2013-03-18
K122702 — BIOFRIEND BIOMASK N95 SURGICAL RESPIRATORFilligent Limited·Product code ONT·2013-03-18
K123219 — URGOCLEAN ABSORBENT WOUND DRESSINGLaboratoires Urgo·Product code FRO·2013-03-18
K123485 — JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOFBiomet Sports Medicine·Product code MBI·2013-03-18
K123546 — 3M ATTEST(TM) AUTO-READER3M Company·Product code FRC·2013-03-18
K123628 — STERILE LATEX SURGICAL GLOVELucenxia Prescience AG·Product code KGO·2013-03-18
K123767 — LANX FUSION SYSTEM- SALanx, Inc.·Product code OVD·2013-03-18
K123890 — ACUMED CANNULATED SCREW SYSTEMAcumed, LLC·Product code HWC·2013-03-18
K121520 — ULTRASONIC NEBULIZER (MESH TYPE)K-Jump Health Co., Ltd.·Product code CAF·2013-03-15
K121593 — 3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK3M Company·Product code FRC·2013-03-15
K122415 — X-FIX DYNAMIC EXTERNAL DISTRACTORArex USA, LLC·Product code HTY·2013-03-15
K122918 — RAYSCAN A-EXPERTRay Co., Ltd.·Product code MUH·2013-03-15
K123070 — GALILEOS FAMILYSirona Dental Systems GmbH·Product code OAS·2013-03-15
K123108 — TVC IMAGING SYSTEM MODEL NIRS-MC7-70Infraredx, Inc.·Product code OGZ·2013-03-15
K123225 — BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60Aap Biomaterials GmbH & Co. KG·Product code LOD·2013-03-15
K123298 — FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATINGEdwards Lifesciences, LLC·Product code DWF·2013-03-15
K130138 — SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMRoche Diagnostics Corp.·Product code NBW·2013-03-15

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