FDA 510(k) clearances — page 332
clearances on record, most recent first.
Clearances — page 332
33,101–33,200 of 175,770- K152513 — 8X-10-XXXX Camera System
- K152651 — AccuLIF TL and PL Cage
- K152945 — Alevicyn SG Antipruritic Gel
- K153483 — Balloon controller PB-30
- K150408 — V-STEADY, V-FAST
- K150769 — Cardinal Health Trochanteric IM Nail System
- K150782 — AbStats Gateway
- K150854 — ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut
- K151611 — OneTouch Ultra Plus Flex Blood Glucose Monitoring System
- K151926 — QuickRay HD Intraoral Sensor
- K152172 — Econsole1
- K152202 — Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm
- K152323 — Disposable Infusion Needle, Safelock Disposable Infusion Needle
- K152341 — ViSi Mobile Monitoring System
- K152554 — Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology
- K152767 — OTC12D AUTO RADIOGRAPHIC SYSTEM
- K153122 — Endoskeleton(r) TCS System
- K150877 — ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
- K143013 — Spinal Inner Fixation System
- K143222 — FIREFLY Pedicle Screw Navigation Guide
- K143514 — Panther StereoSeed
- K150300 — Liquichek Cardiac Markers Plus Control LT
- K151114 — Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein
- K151381 — Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye
- K151767 — Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator
- K151900 — VariLift-L Interbody Fusion Device
- K151991 — Safelock Disposable Blood Collection Set, Disposable Blood Collection Set
- K152153 — MicroSpot Handpiece
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.