FDA 510(k) clearances — page 183
clearances on record, most recent first.
Clearances — page 183
18,201–18,300 of 176,479- K201945 — KARL STORZ UDEL Sterilization Trays
- K201969 — SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System
- K201971 — SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System
- K202240 — Disposable Surgical Mask/Fluid Resistant Procedure Mask
- K202420 — Infrared Forehead Thermometer
- K202514 — EchoS Family
- K202988 — Tixel System
- K202990 — NinesMeasure
- K203247 — iFuse-TORQ Implant System
- K203332 — Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C
- K203477 — Classic
- K203524 — Surgical Masks
- K203578 — OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
- K203665 — STOP U Model UXV Device
- K210230 — Phenom Catheters
- K200734 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
- K201703 — PROXEO Twist Cordless Polishing System PL-40 H
- K201906 — Trinity ELE Plus and Trinity ELE Plus Pro
- K202003 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
- K202184 — Practical Navigation Surgical Guidance System (PNSGS)
- K203255 — 4K UHD Laparoscope
- K203479 — ExtremiLOCK Lateral Ankle Fusion Plates
- K210195 — Triever Catheters
- K210202 — BioWaveGO RX
- K210239 — CITRESPLINE and CITRELOCK ACL Implants
- DEN200028 — Lumenis Stellar M22
- K200439 — Velano ExT Extension Set
- K201501 — Veolity
- K201743 — ClarifEye R1.0, ClarifEye Needle
- K201915 — GenesisZr 4Y+ (ST1100) Zirconia
- K202048 — Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
- K202339 — Molekule Air Mini, Molekule Air Mini +
- K202789 — Monaco Rtp System
- K202950 — StitchKit COMBO
- K203406 — Lumify Diagnostic Ultrasound System
- K203494 — Nissha Medical Technologies Neutral Electrodes
- K203784 — PreXion3D Explorer PRO
- K203804 — Global Med Systems Milesman Compact Laser
- K210190 — ClotTriever Thrombectomy System
- K210269 — PowerDot PD-01MT2 Muscle Stimulator
- K200062 — Foot and Ankle System
- K201652 — COBRA-OS Kit
- K201868 — Phyziofit Medical Surgical Mask
- K202662 — Parcus Titanium Interference Screws
- K203493 — MectaLock Extension
- K203522 — Surn5 Electrosurgical Argon Beam Generator and Accessories
- K210240 — Air Compression Therapy Device, model HW6007
- K202112 — Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
- K200527 — pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur
- K200589 — MyPAO Planning Report
- K201182 — iMask Disposable Surgical Face Mask
- K201274 — Ultrasonic Osteotomy Surgical System
- K201379 — Artemis Proximal Femoral Nail System
- K201425 — Disposable Intraoperative Probe (DIOP8)
- K201680 — NuFACE Mini Plus
- K201860 — Elos Accurate Hybrid Base
- K202188 — Safety Blood Collection Sets for Single Use
- K202212 — TruPlan
- K202232 — Comprehensive Vault Reconstruction System
- K202303 — CORE E3 Suction/irrigator
- K202346 — SPiN Vision Video Bronchoscope System
- K202380 — Born PT-LIF Cage HA
- K202432 — MiniLoad Syringe
- K202616 — ClearCap Distal Attachment
- K202995 — X-ray Flat Panel Detectors/CareView 3600RF
- K203442 — Inbrace Orthodontic System
- K203462 — Advanced Dental Appliance
- K203488 — emField
- K203754 — Eustachi Ear Pressure Relief Device
- K210155 — Duo Expandable Interbody Fusion System
- K210167 — DELTA XTEND Reverse Shoulder System
- K210192 — A.L.P.S. Clavicle Plating System
- K193330 — Clue Birth Control
- K201378 — 3D Accuitomo 150N
- K201408 — Demetra Analytics Toolkit
- K201412 — BEGO SEMADOS Tr 58350 +4 more
- K201720 — LiPPS Analyzer, LiPPS Wire Pressure Guide Wire
- K201863 — Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape
- K202498 — 4CIS SARA Spine System, 4CIS VERTU Spine System
- K202573 — LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
- K202574 — LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
- K202687 — Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60
- K203426 — Surgical Face Mask (non-sterile)
- K210136 — PhantomMSK Hip
- K210137 — EsoCheck Cell Collection Device
- K210329 — Green X 18(Model : PHT-75CHS)
- K202338 — SpaceFlex Shoulder
- K202401 — Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein
- K203307 — VIOLA
- K203399 — FITBONE(R) TAA
- K210132 — s-Clean SQ-SL Implant System Regular
- K210252 — iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System
- K200626 — VesselIQ Xpress
- K201391 — Easytech® Anatomical Shoulder System
- K201732 — Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On
- K203312 — Vitrea Software Package, VSTP-001A
- K203419 — Relivion
- K203670 — Extra Large Check-Flo Introducer
- K210035 — ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System
- K210114 — Rebar Micro Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.