FDA 510(k) clearances — page 445

176,542 clearances on record, most recent first.

Clearances — page 445

44,401–44,500 of 176,542

K112368 — CAPNOSTREAM20P WITH AI/ODIOridion Medical 1987 , Ltd.·Product code CCK·2012-07-19
K112622 — HANDHELD ECG MONITORBeijing Choice Electronic Technololgy Co., Ltd.·Product code DPS·2012-07-19
K113382 — ACE ALT REAGENTAlfa Wassermann·Product code CKA·2012-07-19
K113754 — CFR QUANTUniversity of Texas Medical School AT Houston·Product code KPS·2012-07-19
K120211 — SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATINGSmith & Nephew, Inc.·Product code LZO·2012-07-19
K120598 — PROCARE MONITOR B40Ge Medical Systems China Co., Ltd.·Product code MHX·2012-07-19
K120834 — CORPATH 200 SYSTEMCorindus, Inc.·Product code DXX·2012-07-19
K120865 — RSCRIBE ELECTROCARDIOGRAPHMortara Instrument, Inc.·Product code DPS·2012-07-19
K120970 — NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE)Tangshan Zhonghong Pulin Plastic Co.,Ltd·Product code LZA·2012-07-19
K121270 — BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEMBioject Medical Technologies, Inc.·Product code KZE·2012-07-19
K121572 — CONTINUOUS SINGLE CULTURE COMPLETEIrvine Scientific Sales Co., Inc.·Product code MQL·2012-07-19
K121868 — MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)Hologic, Inc.·Product code HIH·2012-07-19
K120325 — CONNECTED CARE MOBILE APPLICATIONWatermark Medical·Product code DRG·2012-07-18
K120366 — INTELLIVUE PATIENT MONITORPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN·Product code MHX·2012-07-18
K120640 — INSUFLOW SYNERGY PORTLexion Medical, LLC·Product code HIF·2012-07-18
K120824 — 3.9MM REELX STT SUTURE ANCHOR SYSTEMStryker Corp.·Product code MBI·2012-07-18
K121115 — M.U.S.T PEDICLE SCREW SYSTEMMedacta International·Product code KWP·2012-07-18
K121162 — POLARIS Q-SWITCH RUBY SYSTEMSandstone Medical Technologies, LLC·Product code GEX·2012-07-18
K121319 — ZIO PATCHiRhythm Technologies, Inc.·Product code DSH·2012-07-18
K121323 — MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATEMedicrea International·Product code KWQ·2012-07-18
K121349 — IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHERExtremity Medical, LLC·Product code HWC·2012-07-18
K121355 — WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITORSejoy Electronics & Instruments Co., Ltd.·Product code DXN·2012-07-18
K121417 — XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEMExtremity Medical, LLC·Product code HWC·2012-07-18
K121638 — ST80I STRESS TEST SYSTEMPhilips Health Care·Product code DQK·2012-07-18
K121671 — PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEMZimmer Spine, Inc.·Product code NKB·2012-07-18
K121777 — U2 ACETABULAR CUP, PLASMA SPRAYUnited Orthopedic Corp.·Product code LPH·2012-07-18
K111353 — ACCU-CHECK COMBO SYSTEMRoche Diagnostics·Product code LZG·2012-07-17
K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTSPolymed Therapeutics, Inc.·Product code JHI·2012-07-17
K113311 — TIO2MESH TMBiocer Entwicklungs GmbH·Product code FTL·2012-07-17
K120562 — PERFORMAX PEDIATRIC EE TOTAL FACE MASKRespironics, Inc.·Product code BZD·2012-07-17
K121253 — MERIDIAN CRANIAL PERFORATORAdeor Medical Technologies GmbH·Product code HBF·2012-07-17
K121428 — NON-CONTACT CLINICAL THERMOMETERRadiant Innovation, Inc.·Product code FLL·2012-07-17
K121531 — A&J 5L POCA SERIES OXYGEN CONCENTRATORZhongshan A&J Medical Equipment Co., Ltd.·Product code CAW·2012-07-17
K121832 — RESOLVE BILIARY LOCKING DRAINAGE CATHETERMerit Medical Systems, Inc.·Product code FGE·2012-07-17
K121954 — NMI MICROCATHETERNavilyst Medical, Inc.·Product code DQO·2012-07-17
K113306 — CARDIO 7Bionet Co., Ltd.·Product code DPS·2012-07-16
K113335 — HEARTRAIL III GUIDING CATHETERTerumo Corporation·Product code DQO·2012-07-16
K113446 — VIGNET TELEHEALTH MANAGERVignet, Inc.·Product code DRG·2012-07-16
K113562 — 3MP COLOR LCD MONITOR, RADIFORCE RX340Eizo Nanao Corporation·Product code LLZ·2012-07-16
K120253 — ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)Elcam Medical Acal·Product code DRG·2012-07-16
K120564 — CALYPSO SYSTEMHogan Lovells US LLP·Product code NKB·2012-07-16
K120920 — HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULAHsiner Company·Product code BZD·2012-07-16
K121160 — MAGNETOM SPECTRASiemens Medical Solutions USA, Inc.·Product code LNH·2012-07-16
K121474 — DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTERChangzhou Kangdi Medical Stapler Co., Ltd.·Product code GDW·2012-07-16
K121600 — ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITEEthicon Endo-Surgery, LLC·Product code GDW·2012-07-16
K121833 — OSTOMY IRRIGATION SETColoplast A/S·Product code EXD·2012-07-16
K121837 — NUVASIVE BRIGADE ANTERIOR PLATE SYSTEMNuvasive, Inc.·Product code KWQ·2012-07-16
K111014 — LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIESLsi Solutions, Inc.·Product code HEW·2012-07-13
K112390 — MONICA AN24Monica Healthcare, Ltd.·Product code OSP·2012-07-13
K112413 — RI MSC (MIGRATION SEDIMENTATION CHAMBER)Research Instruments , Ltd.·Product code MQK·2012-07-13
K112840 — CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTORSeebreath AB·Product code CCK·2012-07-13
K113192 — HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEMInfopia Co, Ltd.·Product code NBW·2012-07-13
K113374 — ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENTAlfa Wassermann Diagnostic Technologies, Inc.·Product code CIX·2012-07-13
K113513 — PLANCETMicropoint Technologies Pte, Ltd.·Product code FMK·2012-07-13
K113574 — FLEXITIME MONOPHASE PRO SCANHeraeus Kulzer, LLC·Product code ELW·2012-07-13
K120402 — CRUX VENA CAVA FILTER SYSTEMCrux Biomedical·Product code DTK·2012-07-13
K120413 — SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACKFocus Diagnostics, Inc.·Product code OCC·2012-07-13
K120481 — LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,Tosama, D.O.O.·Product code HEB·2012-07-13
K120827 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)Angiotech·Product code NEW·2012-07-13
K120903 — CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATEAcumed, LLC·Product code HRS·2012-07-13
K121017 — CAPNOGRAPHY PAD (92516)Spacelabs Healthcare·Product code CCK·2012-07-13
K121161 — EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINERActa Medical, LLC·Product code KPE·2012-07-13
K121170 — RESIN 11Respinnovation Sas·Product code BYI·2012-07-13
K121733 — INFILL INTERVERTEBRAL BODY FUSION DEVICEPinnacle Spine Group, LLC·Product code MAX·2012-07-13
K121745 — MANTARAY GUIDEWIRESBridgepoint Medical·Product code DQX·2012-07-13
K121767 — CARDIOBLATE GEMINI SURGICAL ABLATION DEVICEMedtronic, Inc.·Product code OCL·2012-07-13
K110558 — CS1000 LIGHT THERAPY DEVICEGenesis Health Light Corporation·Product code ILY·2012-07-12
K112193 — ARROW REVERSE SHOULDER SYSTEMFournitures Hospitalieres Industrie·Product code PHX·2012-07-12
K113436 — ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENTAlfa Wassermann·Product code CJE·2012-07-12
K113620 — MYRIAN 1.11Intrasense·Product code LLZ·2012-07-12
K120812 — RENAISSANCEMazor Robotics , Ltd.·Product code HAW·2012-07-12
K120836 — 0.9% SODIUM CHLORIDE FLISH SYRINGEAm USA·Product code NGT·2012-07-12
K121113 — BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKERBiopsy Sciences, LLC·Product code NEU·2012-07-12
K121198 — BW685, BW685SBiegler GmbH·Product code LGZ·2012-07-12
K121306 — SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLEArthocare Corporation·Product code GAT·2012-07-12
K121347 — PRESSON ELECTRODERhythmlink International, LLC·Product code GXZ·2012-07-12
K121529 — BLACK NITRILE POWDER-FREE EXAMINATION GLOVESNorthstar Healthcare Holdings·Product code LZA·2012-07-12
K111781 — GYMFORM DUAL FLEX BELT MODEL WB-162Well Brain International , Ltd.·Product code NGX·2012-07-11
K111939 — M/29TM - PRESSURE INJECTABLEFlexicath , Ltd.·Product code FOZ·2012-07-11
K112010 — AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)Trudell Medical Intl.·Product code NVP·2012-07-11
K112748 — SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEMSpinal USA, LLC·Product code KWQ·2012-07-11
K113349 — HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FOThe Binding Site Group , Ltd.·Product code DAE·2012-07-11
K113421 — MINICATXoran Technologies, Inc.·Product code JAK·2012-07-11
K113819 — MONGOOSE ANGIOGRAPHIC CATHETERPediacath, Inc.·Product code DQO·2012-07-11
K120424 — MEDSOURCE IV ADMINSTRATION SETMedsource International, LLC·Product code LHI·2012-07-11
K120650 — POISE PERSONAL LUBRICANTKimberly-Clark Corporation·Product code NUC·2012-07-11
K120969 — AC LENS BRANDED CONTACT LENS CASEArlington Contact Lens Services,Inc.·Product code LRX·2012-07-11
K121746 — RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)Randox Laboratories, Ltd.·Product code JJX·2012-07-11
K121794 — LIQUICHEK URINE CHEMISTRY CONTROLBio-Rad, Diagnostics Grp.·Product code JJY·2012-07-11
K121838 — LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEMLiebel-Flarsheim·Product code MQB·2012-07-11
K121856 — ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSIONC.R. Bard, Inc.·Product code LIT·2012-07-11
DEN120011 — PROTEUS INGESTION CONFINMATION SYSTEMSProteus Biomedical, Inc.·Product code OZW·2012-07-10
K112872 — STATIM 2000 G4 CASSETTEScican , Ltd.·Product code FLE·2012-07-10
K120263 — VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMGenoray Co., Ltd.·Product code MUH·2012-07-10
K120474 — GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAYGyrus Acmi, Inc.·Product code KCT·2012-07-10
K120584 — POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVESWealth on (Jiangsu) Co., Ltd.·Product code LYZ·2012-07-10
K120639 — PERFORMAX PEDIATRIC SE TOTAL FACE MASKRespironics, Inc.·Product code CBK·2012-07-10
K120773 — NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEMCovidien, LLC·Product code DQA·2012-07-10
K121133 — CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEMI-Sens, Inc.·Product code NBW·2012-07-10
K121426 — AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPSSynergetics, Inc.·Product code GEI·2012-07-10

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