FDA 510(k) clearances — page 282

176,542 clearances on record, most recent first.

Clearances — page 282

28,101–28,200 of 176,542

K172591 — Fixed Patient Leads ECG Cable (Model 3153)Boston Scientific Corporation·Product code DSA·2017-11-03
K172609 — CSMC Cardiac SuiteCedars-Sinai Medical Center·Product code KPS·2017-11-03
K172639 — PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd.·Product code GEX·2017-11-03
K172644 — Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading BaseStimwave Technologies Incorporated·Product code GZB·2017-11-03
K172711 — Comet-PLUSNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)·Product code OLV·2017-11-03
K163087 — PixoTest Blood Glucose Monitoring SystemIxensor Company , Ltd.·Product code NBW·2017-11-02
K163223 — ORCA (tm) - Operational Rescue Containment ApparatusIsovac Products, LLC·Product code LGM·2017-11-02
K163453 — VitalPatch® VitalConnect PlatformVitalconnect, Inc.·Product code DRG·2017-11-02
K163646 — Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader IncubatorTerragene S.A.·Product code FRC·2017-11-02
K170080 — Neodent Implant System - CM Pro PEEK AbutmentJjgc Industria E Comercio DE Materiais Dentarios S.A.·Product code NHA·2017-11-02
K170341 — Medussa-PL CageMedyssey USA, Inc.·Product code MAX·2017-11-02
K170405 — BD Curve Ascites ShuntCare Fusion·Product code KPM·2017-11-02
K170422 — BIOSOFT DUO DOUBLE LOOP URETERAL STENTSColoplast Corp.·Product code FAD·2017-11-02
K170853 — InnoSpire GoRespironics Respiratory Drug Delivery (Uk) , Ltd.·Product code CAF·2017-11-02
K171376 — DynaNail TTC Fusion SystemMedShape, Inc.·Product code HSB·2017-11-02
K172301 — Mako Partial Knee ApplicationMako Surgical Corp.·Product code OLO·2017-11-02
K172328 — SOVEREIGN Spinal SystemMedtronic Sofamor Danek USA, Inc.·Product code OVD·2017-11-02
K172373 — Compound W Nitro-FreezeMedtech Products, Inc.·Product code GEH·2017-11-02
K172407 — DuracetalThe Myerson Company Limited·Product code EBI·2017-11-02
K172437 — CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.·Product code ODP·2017-11-02
K172674 — Sapphire Cervical Implant SystemSapphire Medical Group·Product code ODP·2017-11-02
K172757 — Valleylab FX8 Electrosurgical PlatformCovidien, LLC·Product code GEI·2017-11-02
K173232 — myMerlin(TM) Mobile Application Model APP1001St Jude Medical·Product code MXC·2017-11-02
K173341 — Vivid E80, Vivid E90, Vivid E95GE Medical Systems·Product code IYN·2017-11-02
K162812 — Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion SetUnomedical A/S·Product code FPA·2017-11-01
K170353 — ABX MICROS ES 60 OT and ABX MICROS ES 60 CTHORIBA ABX SAS·Product code GKZ·2017-11-01
K170437 — Sterisheet Sterilization WrapAndersen Sterilizers, Inc.·Product code FRG·2017-11-01
K170439 — AN87 DosimeterAndersen Sterilizers, Inc.·Product code JOJ·2017-11-01
K170513 — MAUSER PG II Sharps ContainerMauzer USA, LLC·Product code MMK·2017-11-01
K170767 — Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc.·Product code GAQ·2017-11-01
K171026 — Mytens Model: BW-TSXBewell Connect Corp.·Product code NUH·2017-11-01
K171370 — IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation·Product code NFJ·2017-11-01
K171580 — Monitor B125, Monitor B105Ge Medical Systems (China) Co., Ltd.·Product code MHX·2017-11-01
K172144 — CoolSculpting SystemZeltiq Aesthetics·Product code OOK·2017-11-01
K172347 — GMK Hinge, GMK RevisionMedacta International S.A.·Product code KRO·2017-11-01
K172649 — Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with MulticolorHeidelberg Engineering GmbH·Product code OBO·2017-11-01
K173175 — Paramount Anterior Cervical Cage SystemSpine Wave, Inc.·Product code OVE·2017-11-01
K170359 — Trinity Dual Mobility SystemCorin U.S.A. Limited·Product code LZO·2017-10-31
K170427 — Anprolene SteriTestAndersen Sterilizers, Inc.·Product code FRC·2017-10-31
K170432 — Anprolene AN75 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc.·Product code FLF·2017-10-31
K171708 — ALOKA ARIETTA 850Hitachi Healthcare Americas Corporation·Product code IYN·2017-10-31
K171767 — Cianna Medical SAVI Scout Reflector and SAVI Scout SystemCianna Medical, Inc.·Product code NEU·2017-10-31
K172268 — iFuse Implant System- iFuse NavigationSI-BONE, Inc.·Product code OLO·2017-10-31
K172333 — Sysmex CS-5100Siemens Healthcare Diagnostics Products GmbH·Product code JPA·2017-10-31
K172447 — JO Gelato Flavored Personal LubricantsUnited Consortium·Product code NUC·2017-10-31
K172572 — Stryker Upper-Face AXS screws and Mid-Face AXS screwsStryker·Product code JEY·2017-10-31
K173080 — IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co. , Ltd.·Product code MAX·2017-10-31
K173318 — Rapid HB, Rapid LB, Rapid MB3M Deutschland GmbH·Product code ELW·2017-10-31
K163659 — Crystal VisionI.C Medical, Inc.·Product code FYD·2017-10-30
K170426 — AN85/AN86 EO IndicatorsAndersen Sterilizers, Inc.·Product code JOJ·2017-10-30
K170917 — Bi-Ostetic Bioactive Glass FoamBerkeley Advanced Biomaterials·Product code MQV·2017-10-30
K171008 — Anorganic Bone Mineral with Collagen in Delivery ApplicatorCollagen Matrix, Inc.·Product code NPM·2017-10-30
K171525 — Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc.·Product code OLO·2017-10-30
K171643 — Geistlich Bio-Gide Shape, Geistlich Bio-Gide CompressedGeistlich Pharma AG·Product code NPL·2017-10-30
K172236 — Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox SledAvinger, Inc.·Product code MCW·2017-10-30
K172296 — Stethee ProM3Dicine Pty , Ltd.·Product code DQD·2017-10-30
K172326 — Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics·Product code JWH·2017-10-30
K172351 — AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket InsertEncore Medical L.P.·Product code KWS·2017-10-30
K172402 — ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitLuminex Corporation·Product code PGX·2017-10-30
K172404 — SenoBright HDGE Healthcare·Product code MUE·2017-10-30
K172646 — XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation·Product code OWB·2017-10-30
K172943 — Flex-Thread Fibula Pin SystemIntrafuse, LLC·Product code HSB·2017-10-30
DEN170030 — VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary AntibodyVentana Medical Systems·Product code PZJ·2017-10-27
K162738 — Puritan Bennett 980 Ventilator SystemCovidien·Product code CBK·2017-10-27
K170345 — SOFTDISOBest Nomos·Product code IYE·2017-10-27
K170429 — Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc.·Product code FRG·2017-10-27
K170466 — Automatic Blood Pressure Monitor Model LD-518 & LD-537Honsun (Nantong) Co., Ltd.·Product code DXN·2017-10-27
K170585 — SkylifeNeolight, LLC·Product code LBI·2017-10-27
K171926 — C5 Diagnostic Ultrasound SystemGuangzhou Sonostar Technologies Co., Ltd.·Product code IYN·2017-10-27
K171979 — Tubing PackMedtronic, Inc.·Product code DWF·2017-10-27
K172028 — Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer Company·Product code MLY·2017-10-27
K172038 — TrocarWickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd·Product code GCJ·2017-10-27
K172077 — Cutera enlighten III Laser SystemCutera, Inc.·Product code GEX·2017-10-27
K172087 — SANGRAYHitachi , Ltd.·Product code MOT·2017-10-27
K172133 — ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd.·Product code CDD·2017-10-27
K172534 — LINACwatch, LinacViewQualiformed Sarl·Product code IYE·2017-10-27
K172803 — Infinitt PACS 7.0Infinitt Healthcare Co., Ltd.·Product code LLZ·2017-10-27
K172815 — 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)Shenzhen Beacon Display Technology Co., Ltd.·Product code PGY·2017-10-27
K173104 — Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® PolyTotal Joint Orthopedics, Inc.·Product code OQG·2017-10-27
K173122 — Abbott Architect Free T4Abbott Laboratories·Product code CEC·2017-10-27
K173132 — ASPIRE CristalleFujifilm Medical Systems U.S.A, Inc.·Product code MUE·2017-10-27
K173138 — Biim Diagnostic Ultrasound SystemBiim Ultrasound AS·Product code IYO·2017-10-27
K173184 — Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific·Product code ODG·2017-10-27
K171142 — Healing Cap Multi-Unit TitaniumNobel Biocare AB·Product code NHA·2017-10-26
K171831 — Intra-Lock Bone Fixation SystemIntra-Lock International, Inc.·Product code DZL·2017-10-26
K171931 — Celerity ECG Cable Accessory PackMedcomp (Medical Components, Inc.)·Product code LJS·2017-10-26
K172323 — Omnia Medical VBROmnia Medical, LLC·Product code MQP·2017-10-26
K172325 — Rhapsody H-30 Holmium Laser SystemCook Incorporated·Product code GEX·2017-10-26
K172341 — NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated·Product code MAX·2017-10-26
K172417 — SILC® Fixation SystemGlobus Medical, Inc.·Product code OWI·2017-10-26
K172994 — EPI K ConsoleMoria SA·Product code HNO·2017-10-26
K173022 — SeaSpine Ventura NanoMetalene SystemSeaSpine Orthopedics Corporation·Product code MAX·2017-10-26
K173046 — Cocoon Portable Handheld X-Ray SystemDexcowin Co., Ltd.·Product code MUH·2017-10-26
K173094 — OrthoVisionEwoosoft Co., Ltd.·Product code LLZ·2017-10-26
K162652 — Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation·Product code NFO·2017-10-25
K163050 — Advance Medical Designs, Inc. Sterile Ultrasound GelAdvance Medical Designs, Inc.·Product code MUI·2017-10-25
K170226 — iTotal Family Reusable Instrument TrayConformis, Inc.·Product code KCT·2017-10-25
K170293 — Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.·Product code DIO·2017-10-25
K170307 — SunCHECKSun Nuclear Corporation·Product code IYE·2017-10-25
K170423 — DentureID MicrochipCmp Industries, LLC·Product code PYQ·2017-10-25

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