FDA 510(k) clearances — page 338
clearances on record, most recent first.
Clearances — page 338
33,701–33,800 of 176,542- K153069 — Edwards Balloon Catheter
- K153214 — Full Automatic (NIBP) Blood Pressure Monitor
- K153217 — ConforMIS iTotal Posterior Stabilized Knee Replacement System
- K153336 — VuePoint OCT System
- K153427 — Volpara Imaging Software
- K153531 — Treace Medical Concepts (TMC) Plating System
- K153541 — Coldplay CryoBalloon® Ablation System
- K151104 — OTELO LL
- K151287 — Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D
- K151310 — Amendia Interbody Fusion Devices
- K151662 — iRestore
- K152313 — Medline ReNewal Reprocessed Endopath Endoscopic Instruments
- K152604 — KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set
- K152944 — Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems
- K153233 — Galaxy UNYCO System
- K153259 — VasoStat Hemostasis Device
- K153502 — ClariVein IC
- K153536 — Piccolo Composite® Nailing System
- K143004 — VENTURI MiNO TG600/14
- K150459 — FloSure Ventilation Patch
- K151771 — Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
- K152498 — SoloPath Re-Collapsible Access System
- K152536 — MyOn HC Manual Wheelchair
- K152872 — K2M Fenestrated Tap System
- K152954 — Quell
- K153190 — Zenysis Short-Term Dialysis Catheter
- K153265 — New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated
- K151273 — InMode FRF Applicator
- K151511 — ROSA Spine
- K153037 — LOGIQ V1/ LOGIQ V2
- K153052 — Erchonia PL Touch
- K152746 — Ez3D Plus
- K150585 — Ascent 3D
- K152508 — Ageless Health Medical Digital Thermometer
- K152644 — KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100
- K152809 — Giraffe Incubator Carestation CS1
- K153094 — Visions PV .035 Digital IVUS Catheter
- K153208 — Internal Joint Stabilizer - Elbow
- K151255 — Navigator Aesthetic Delivery System
- K151686 — HumanPen Ergo II
- K151876 — Bio2 Fusion Implant System
- K151907 — Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables
- K152201 — MedActive Oral Gel and Spray
- K152373 — VITA VM LC Flow
- K152586 — Beacon Fine Needle Fiducial System
- K152889 — SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS
- K152968 — Arsenal Spinal Fixation System
- K153463 — CD HORIZON Spinal System, IPC POWEREASE System
- K150729 — SpectraShield 9500 Surgical N95 Respirator
- K150841 — Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant
- K151025 — iHearTest
- K152112 — VisualEyes
- K152860 — HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL
- K153053 — Traxcess Pro 14 Guidewire
- K151364 — Intellijoint HIP(tm) System
- K151762 — PediatrOS RigidTack/FlexTack
- K152951 — Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray
- K153154 — Asnis JFX System
- K153158 — Solution Administration Sets with 0.2 Micron Filter
- K152162 — Myray- HYPERION X5
- K152283 — MAGNETOM Amira
- K152542 — Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs
- K152851 — BrainPort V100
- K153492 — CareView 1800L
- DEN140024 — cNEP Airway
- K142879 — BTM Wound Dressing
- K150676 — L-Mesitran Dressing Family II- Soft and Tulle
- K151567 — ENDOPLUS hand-held laparoscopic instruments
- K151890 — Medical Diode Laser Systems
- K152047 — INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
- K152128 — 2-in-1 Abdominal Muscle Training & Back Pain Relief System
- K152330 — Expression MR400 MRI Patient Monitoring System
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.