FDA 510(k) clearances — page 213
clearances on record, most recent first.
Clearances — page 213
21,201–21,300 of 176,479- K192662 — CapsoCam Plus (SV-3) Capsule Endoscopy System
- K192923 — Vitrea Software Package
- K193120 — Real Intelligence Cori
- K193152 — Affinity
- K193245 — Dunamis PunchTac Suture Anchors
- K193248 — Biograph Vision, Biograph mCT Family of PET/CTs
- K193475 — OneTouch Verio Reflect Blood Glucose Monitoring System
- K193502 — TGS Universal Headrest with Mounting Arm
- K193567 — VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 >=16 ug/mL)
- K193644 — E-COM DR-2000 DR
- K200083 — EMBA Hourglass Peripheral Embolization Device (PED)
- K183024 — Implacil Implant System
- K190882 — XenoSure Biologic Patch
- K190909 — ArtiSential Bipolar Fenestrated Forceps
- K191689 — EleGARD Patient Positioning System
- K191828 — Vathin Video Bronchoscope System
- K191829 — Microlife Non-Contact Infrared Forehead Thermometer
- K191966 — NewPrim System
- K192022 — DiaTemp Flow
- K192158 — DiaTemp
- K192233 — LED Curing Light
- K192414 — Praxiject 0.9% NaCl
- K192557 — Youjia Unscented Tampon with Plastic Applicators
- K192614 — Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment
- K192828 — Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System
- K193168 — Agilon Moldable
- K193224 — Daytona® Small Stature Growth Rod Conversion Set
- K193232 — Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology
- K193472 — OrthoCircle Spine Pedicle Screw System
- K193489 — ADVIA Centaur BR
- K193498 — Infinitt RT PACS
- K200079 — ClearPoint System and Accessories
- K191235 — Leltek Ultrasound Imaging System
- K193178 — Biograph Horizon
- K191202 — CAPENERGY - C100, C200, C300, C400, C50
- K191453 — Cervitec F
- K192165 — Acteon Imaging Suite
- K192596 — ULab Systems Dental Aligner Kit
- K193013 — AcQMap High Resolution Imaging and Mapping System
- K200182 — EzRay Air Portable (Model: VEX-P300)
- DEN190038 — Surfacer Inside-Out Access Catheter System
- K190192 — K3Pro Konus New Abutments and Implants
- K191919 — Elos Accurate Hybrid Base
- K192203 — JO for Him H2O Gel Original Personal Lubricant
- K192377 — Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon
- K192749 — Dermadry
- K192841 — InPen System
- K192846 — Argen Clear Aligner, Argen Clear Aligner Premium
- K193156 — Arthrex Mini Comprehensive Fixation System - 1.0mm Screws
- K193165 — MectaFix CL Fixation Button with Continuous Loop
- K193587 — Sutter Swyng non-stick bipolar forceps, single-use
- K200065 — cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System
- K200130 — M.U.S.T. MINI Posterior Cervical Screws System
- DEN190040 — Caption Guidance
- K182927 — Pulmonary Cytology Brush
- K183678 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K183688 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K190259 — Vesta RF Cannula
- K191298 — i-STAT CHEM8+ cartridge with the i-STAT 1 System
- K191347 — Paragon XHD Diagnostic Ultrasound System
- K191416 — Desara One Single Incision Sling System, 1 Pack; Desara One Single Incision Sling System, 3 Pack
- K191975 — Elefix V Paste for EEG & EMG
- K192273 — DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit
- K192527 — Rochal Antimicrobial Wound Gel
- K193103 — NeoBase 2 Non-derivatized MSMS Kit
- K193129 — Yukon OCT Spinal System
- K193154 — 3M Attest Super Rapid 5 Steam-Plus Challenge Pack
- K200117 — Trevo NXT ProVue Retriever
- K190800 — Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors
- K191290 — Ancora Nerve Block Catheter Set
- K191411 — Ah!Yes Ob Coco Personal Lubricant
- K191529 — da Vinci Xi Surgical System, da Vinci X Surgical System
- K191571 — UV Radiation Treatment System
- K191890 — Elos Accurate Customized Abutment
- K192002 — Lucy Point-of-Care Magnetic Resonance Imaging Device
- K192757 — VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of 20, VitalPatch 7D Biosensor bag of 20
- K193461 — MectaLock All-Suture Anchors
- K193521 — Steerable Plateau Ti
- K193610 — BreathID Smart System
- K180935 — Infinity / Infinity Cross Flex Dental Systems
- K192127 — Respire Pink AT (Hard, Hard/Soft, EF)
- K192785 — OptiScanner® 5000 Glucose Monitoring System
- K192806 — DENTCA Crown and Bridge
- K193396 — PERLA® TL posterior osteosynthesis system
- K200038 — Endosee System
- K200170 — SpineNet SSP System
- K183148 — OKLand Patient Return Electrode Pad
- K191532 — The Caterpillar and Caterpillar Micro Arterial Embolization Devices
- K191832 — Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)
- K192688 — s-Clean SQ-SL Implant System Regular
- K193320 — KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
- K193324 — Motion Correction System
- K193398 — Summit DuoFix HA Coating
- K200050 — Akesis Galaxy RTx
- K190842 — Comus Locking Plate systems
- K190962 — Bella-mu
- K190966 — Katalyst Training System
- K192579 — X-Guide Surgical Navigation System
- K193128 — Mako Total Hip Application
- K200030 — Optima Coil System
Data sourced from openFDA. This site is unofficial and independent of the FDA.