FDA 510(k) clearances — page 104
clearances on record, most recent first.
Clearances — page 104
10,301–10,400 of 175,620- K230523 — s-Clean Link Abutment Narrow
- K223504 — Ceribell Status Epilepticus Monitor
- K230096 — Genius AI Detection 2.0 with CC-MLO Correlation
- K230134 — Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002
- K230152 — uMR Omega
- K230564 — Green Non Sterile Powder Free Nitrile Examination Gloves
- K230803 — ADAS 3D
- K230874 — Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath
- K231162 — ROSA Hip System
- K231178 — ACTERA hip system
- K220722 — PVC Hydrophilic Urethral Catheter
- K222705 — Introducer Needle
- K223839 — TrueBeam, TrueBeam STx, Edge, VitalBeam
- K223860 — Integrity Bone Staple Fixation System
- K230373 — HELIOS 785 Pico
- K230443 — TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
- K230460 — Laser Thermal Therapy Kit
- K230464 — MixJect® Transfer Device
- K230465 — Hi-Bond Universal
- K230631 — Kodiak Dual Port Coaxial Introducer Kit
- K230708 — Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)
- K231168 — TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
- K231464 — 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
- K212758 — Autoplaque
- K220402 — VirtuOst
- K220842 — Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
- K220916 — iLet® Dosing Decision Software
- K221323 — Exactech® Alteon® Short Tapered Wedge
- K222545 — Disposable Medical Mask
- K222703 — ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX)
- K222833 — Ventana C Spinal System
- K222979 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W
- K223486 — SafeBreak® Vascular
- K223846 — iLet® ACE Pump
- K230375 — BIOMONITOR IV
- K230416 — Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®
- K230537 — Klassic Knee Revision System
- K230769 — PrevisEA Device
- K230790 — Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
- K231137 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
- K231140 — aprevo® transforaminal lumbar interbody fusion device
- K231143 — GI Genius System 100 and GI Genius System 200
- DEN220027 — B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System
- K220829 — Endo Motor
- K222356 — Claritag Advanced
- K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
- K223269 — Spencer Probe Depth Electrodes
- K223276 — Anchor Bolts as Accessories to Depth Electrodes
- K223645 — I.V. Administration Set, I.V. Extension Set
- K223725 — Restrata® MiniMatrix
- K230200 — Single-Use Flexible Ureteroscope
- K230432 — Single Use Bipolar Forceps
- K230453 — OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter
- K230479 — ComASP Cefiderocol 0.008-128
- K230723 — C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
- K230758 — uMR 570
- K231113 — Arthrex FiberTak Suture Anchor
- K222728 — Radiation Planning Assistant (RPA)
- K223437 — Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour)
- K223696 — F&P Solo Mask Range
- K230286 — Assert-IQ Insertable Cardiac Monitor
- K230448 — DeepX DermoSight Dermatoscope
- K231102 — Symbia Pro.specta VA20A Family
- K231128 — JuggerKnot Soft Anchor
- K220964 — VERSAJET Hydrosurgery System (III)
- K222024 — Evita V800, Evita V600
- K222207 — Babylog VN800, Babylog VN600
- K222254 — Gunther Tulip Vena Cava Filter Retrieval Set
- K222560 — BlueCheck Caries Detection & Monitoring
- K222736 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
- K222812 — Insufflator
- K222912 — c1Trac
- K223893 — Infrared Heat (Model: E0221)
- K230219 — Eminent Spine 3D Lumbar Interbody Fusion Systems
- K230262 — BruxZir Incisal Coloring Liquid
- K230358 — SAVI Dual (TM) Migraine Therapy
- K202993 — Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H)
- K220526 — HD+12, HD+15
- K222836 — Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
- K223836 — Vathin® Video Bronchoscope System
- K230121 — Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
- K231081 — Dexcom G7 Continuous Glucose Monitoring (CGM) System
- K231391 — Combi Touch
- K223147 — myLEDmask
- K223308 — HEATING TENS/EMS, FT-810R
- K230217 — Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs
- K221969 — IU Implant System Abutment
- K222106 — Waypoint GPS
- K222460 — Intraoperative Ultrasound Probe Cover
- K222489 — Harvest Printable Resin
- K222854 — iTFlow
- K223101 — BD Secondary Infusion Set
- K223706 — PMMA BLOCK
- K230394 — EUROSCREW NG; EUROSCREW TCP NG
- K230414 — ClariVy Cervical IBF System
- K230684 — RadiForce MX217
- K230975 — Ahmed® Glaucoma Valve Model FP7
- K231051 — Ahmed® Glaucoma Valve Model FP8
- K231063 — SOMAVAC® 100 Sustained Vacuum System
- K231190 — EPIQ Series Diagnostic Ultrasound System
Data sourced from openFDA. This site is unofficial and independent of the FDA.