FDA 510(k) clearances — page 331
clearances on record, most recent first.
Clearances — page 331
33,001–33,100 of 175,770- K152406 — SalivaMAX
- K153071 — Solitaire Platinum Revascularization Device
- K141157 — BONDEASE TOPICAL SKIN ADHESIVE
- K142125 — New Medax Biopsy Systems
- K142826 — ADVIA Centaur Toxoplasma M (Toxo M)
- K150664 — NeoLas
- K150831 — Cellvizio 100 Series System with Confocal Miniprobes
- K150997 — RUBY STAR
- K151050 — Pacifier Activated Lullaby (PAL®)
- K151074 — Magnetic Reasonance Imaging System
- K151168 — Nexodyn AOS Wound Care Solution
- K152038 — MammoGRIP
- K152370 — PRECICE Trauma Nail System
- K152460 — Rectangular Corpectomy Cage
- K152852 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
- K153318 — Philips Eleva Workspot with SkyFlow
- K153369 — SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz
- K150817 — Dario Blood Glucose Monitoring System
- K150870 — HydroPearl Microspheres, HydroPearl Microspheres
- K150934 — Powder Free Vinyl Patient Examination Glove (Non?-Sterile)
- K150950 — FreezeKit Cleave , ThawKit Cleave
- K151284 — Electric Double Breast Pumps
- K151445 — Cardinal Health Sterilization Wrap
- K151481 — Sahara Stabilization System
- K151672 — Cerner CareAware Event Management
- K151814 — SERVO-U Ventilator System, SERVO-n Ventilator System
- K152145 — OsteoMed ExtremiLOCK Wrist Plating System
- K152548 — AXI+LINE Proximal Bunion Correction System
- K152692 — Powder Free Vinyl Patient Examination Gloves (Green)
- K152714 — Quanta Forte
- K152755 — FastFrame External Fixation System-Ankle Spanning
- K152774 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL
- K152782 — SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT
- K152875 — QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
- K153085 — Q Series Diagnostic Ultrasound System
- K153092 — Ally Uterine Positioning System
- K153210 — Defibrillator Analyzer Variable Load
- K153378 — Monster BITE Screw System
- K153401 — GR40CW
- K153408 — HM70A Diagnostic Ultrasound System
- K153437 — Apex Revision Knee System
- DEN150005 — Newa Skin Therapy System
- K150682 — CUSA Excel+
- K150748 — Flexipet Denuding Pipette, Flexipet Manipulation Pipette
- K150828 — O-RING Condom
- K150898 — LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm
- K150930 — Deployable Oxygen Generation System-Smaill (DOGS-S)
- K150931 — MReye Embolization Coils
- K150964 — MReye Flipper Detachable Embolization Coil and Delivery System
- K151126 — Foresight Intracardiac Echocardiography (ICE) System
- K151359 — ROSA Brain
- K151413 — Always/Tampax bladder supports
- K151498 — Breathing circuit bacterial/viral filter
- K151916 — TRI Dental Implant System
- K152150 — V8 Balloon Aortic Valvuloplasty Catheter
- K152384 — Digital Electrocardiograph
- K152387 — Fluent Inflation Device
- K152389 — Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit
- K152515 — TOMCAT Cervical Spinal System
- K152532 — AERO -C Cervical Cage System
- K153306 — Imbibe Needle
- K153365 — ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
- K153417 — ST AIA-PACK PROG III Calibrator Set
- K153499 — EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension
- K142785 — PRODIGY iConnect Blood Glucose Monitoring System
- K150792 — Next Science Wound Gel
- K150815 — BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit
- K151022 — Intraluminal Applicator Set
- K151062 — WASTON Metallic Intramedullary Nail System
- K151329 — SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet
- K151370 — UV Lamps for Indoor Tanning Devices
- K151810 — Bpump Blood Pressure Cuff
- K152115 — Renew NCP-5 External Counterpulsation System
- K152155 — ARCHITECT 2nd Generation Testosterone
- K152219 — PK AIM
- K152291 — Sterisheet Sterilization Wrap
- K152386 — NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
- K152442 — Freestyle Freedom Blood Glucose Monitoring Sytem
- K152491 — MoMe Software Platform
- K152636 — Laser Dock
- K152857 — NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps
- K152996 — Molteno3 Glaucoma Implant
- K153189 — Beacon Tissue Marker (SE)
- K153310 — Klassic Knee System
- K153344 — Asahi REXEED-S Series Dialyzer
- K150524 — Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology
- K150806 — PulseFlowDF
- K150908 — XM-01 Electronic Automatic Blood Pressure Monitor
- K150992 — Vios Monitoring System
- K151279 — Counter OTC TENS Device, Model CSD-737Z
- K151840 — Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
- K152118 — Zenostar MT, Zenostar Color Liquids
- K152322 — Resolve 2.0
- K153362 — AquaShield system CO2, AquaShield system-PENTAX
- K153376 — Advanced Perfusion System 1
- K153450 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor
- K153480 — ClearVue850 Diagnostic Ultrasound System
- K151063 — Monitor B40
- K151496 — Latitude-C Cervical Interbody Spacer System
- K152267 — Remedy® Shoulder Spacer
Data sourced from openFDA. This site is unofficial and independent of the FDA.