FDA 510(k) clearances — page 340
clearances on record, most recent first.
Clearances — page 340
33,901–34,000 of 176,542- K152157 — LC Bead LUMI
- K152306 — MotoBand¿ CP Implant System
- K152451 — VINTAGE Art LF
- K152609 — GORE SYNECOR Biomaterial
- K152639 — DR 600
- K152974 — ORTHOLOC® 3Di Foot Plating Reconstruction System
- K152987 — Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System
- K153011 — iViewDose R1.0
- K153088 — AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
- K153257 — BD FlowSmart Set, MiniMed Pro-Set
- K153313 — SpeedLock Knotless Fixation System
- K153461 — Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm
- K142313 — OneQ-SL Implant System
- K150079 — Regenomer® Syringe, Regenomer® Plug, Regenomer® Block
- K150354 — PAPAYA 3D Plus
- K150708 — 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine
- K150869 — Checkme Pro Health Monitor
- K151158 — ALP VasQcare Take Home System
- K151699 — BEAUTIFIL II Enamel
- K151933 — BRX PRO Bruxism Guard
- K152001 — Sterile Repositionable Hemostasis Clipping Device
- K152182 — Fuse Gastroscopy System
- K152326 — Biomet Microfixation OmniMax MMF System
- K152355 — Twin Peaks Lumbar Interbody Fusion System
- K152732 — AOS Small Fragment Plating System
- K153298 — AccuCath Intravascular Catheter
- K150668 — Biodesign Enterocutaneous Fistula Plug
- K151133 — PENTRA XLR
- K151321 — D-100 HbA1c, D-100 HbA1c Calibrator Pack
- K151396 — MIVI Mi-AXUS Guide Catheter
- K152243 — One Coat 7 Universal
- K152467 — Touch Ultrasound
- K153126 — da Vinci Xi Hasson Cone
- K153223 — ProParaFlu+ Assay
- DEN150010 — Dignitana AB DigniCap System
- K150716 — Varaya Sport
- K151127 — higi Station
- K152012 — EVO platform
- K152146 — High Speed Handpieces and Accessories
- K152721 — Cytal Wound Matrix
- K152722 — neoV980 & neoV1470 Diode Lasers
- K151639 — ABL80 FLEX and ABL80 FLEX CO-OX
- K151896 — Houdini Catheter
- K151934 — ROI-C Titanium-Coated Implant System
- K152292 — Respire Blue Series-EF
- K152436 — Suntanning Lamps
- K152624 — XSTAT 30, 3-PACK, XSTAT 30, 1-PACK
- K152783 — Merit 20 mL Syringe
- K152139 — Vital Connect Platform, HealthPatch MD, VitalPatch
- K150833 — iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System
- K150961 — EmbryoSlide Culture Dish
- K150966 — HMB32
- K151936 — Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle
- K152078 — Implant Studio 2015
- K152175 — Upcera Dental Zirconia Blank for Aesthetic Restoration
- K152284 — COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS; COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS
- K152321 — kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening
- K152401 — Stingray LP Catheter
- K152441 — KIRO Set
- K152484 — FastFrame External Fixation System - Distal Radius
- K152958 — INEX Absorbable Nasal Implant
- K153228 — NMI Port, NMI Port II
- K151226 — Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)
- K151714 — Disposable Endoscope Valves Set A
- K152582 — CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
- K152859 — Portable X-ray System (Model: MINIX-V / MINIX-S)
- K152904 — SYDNEY IVF EMBRYO BIOPSY MEDIUM
- K153213 — Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir
- K143711 — Reaxon Plus
- K150722 — EnFocus 2300, EnFocus 4400
- K150787 — Universal Spike
- K152239 — Zero-P Natural Plate System
- K152528 — Attachable Cath Lab Hemostasis Valve
- K152566 — PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors
- K152632 — XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory
- K152840 — Lantern Delivery Microcatheter
- K153140 — Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating
- K153143 — Capiox Advance Hardshell Reservoir
- K150640 — RX-FIX Mini Rail External Fixator
- K151295 — Biodenta Customized Abutment - Titanium
- K151658 — Gmate Origin Blood Glucose Monitoring System
- K151878 — Video Colposcope
- K152060 — 3M Attest Rapid Readout Biological Indicator 1295
- K152121 — NuVent EM Sinus Dilation System
- K152173 — Glidesheath
- K152211 — PCT System
- K152417 — Adler MicroMed Laser Surgery Fibers
- K152943 — NuVasive Foundation-LL System
- K153148 — CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping
- K152518 — Vonflex S Putty
- K150238 — SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color
- K150603 — Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube
- K151186 — Stay Fresh Hydrocolloid dressing
- K151673 — Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)
- K151679 — Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
- K142211 — OT EQUATOR
- K150077 — SonicLift
- K150528 — Cortisol Saliva Luminescence Immunoassay
- K150561 — NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System
- K150942 — Contour Next USB Blood Glucose Monitoring System
Data sourced from openFDA. This site is unofficial and independent of the FDA.