FDA 510(k) clearances — page 103
clearances on record, most recent first.
Clearances — page 103
10,201–10,300 of 175,620- K221801 — ADVIA Centaur® Anti-Müllerian Hormone (AMH)
- K222018 — Breathe+
- K222702 — RGS; RGS Mini
- K222727 — i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)
- K222961 — Harvest Conceal ZR Block Out
- K223074 — CorNeat EverPatch
- K223562 — Xpan Universal Trocar System
- K223822 — ACTIVBRAID
- K230214 — Huma RPM (RPM)
- K230635 — Pen Needle
- K230888 — Titanium Turbine
- K230936 — Anatomic PEEK Cervical Fusion System with Nanotechnology
- K230952 — Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component
- K230971 — APTUS® 3.5 TriLock Straight Plates
- K231309 — SCAR 3
- K231311 — CPS Direct Universal slittable outer guide catheter (DS2C029)
- K231314 — Fine Osteotomy
- K222905 — Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)
- K223299 — Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 Advance
- K223447 — OmniTom Elite
- K223498 — Radius VSM and Accessories
- K223555 — Brainomix 360 e-CTP
- K223676 — SomniCheck
- K223929 — Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System)
- K230185 — ANT-X System
- K230408 — K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)
- K230617 — Surgical Face Mask (L 175*95mm)
- K230827 — HardyDisk AST Rezafungin 5µg (RZF5)
- K230990 — Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)
- K231293 — Drakon and Sequre® Microcatheters
- K231306 — cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
- K231330 — FiberTak® Suture Anchor
- K211056 — Oxus Sieve Beds
- K213010 — FEELject LDV (Low dead volume) syringe
- K213992 — CombiSet Hemodialysis Blood Tubing Set
- K221067 — Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
- K222556 — BTL-785X
- K222644 — Nihon Kohden NKV-440 Ventilator System
- K222885 — Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
- K230542 — Disposable Nitrile Gloves (ABC-DG01)
- K230671 — Pitch PaSoft Tissue Reinforcement Device
- K231259 — iRoot SP Plus
- K231326 — Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)
- K220706 — MyPAO Guides
- K221897 — Hydrozid Precise
- K222359 — Quicktome Software Suite
- K223523 — Sonic DL
- K223762 — Smith & Nephew ACCORD Cable System
- K223809 — PrecisionTAVI (v1.1)
- K223841 — KBA3D
- K230030 — Excipio SV Aspiration Catheter and Tubing
- K230278 — Babyroo TN300
- K230571 — RFP-100A Connector Cable (Single Use)
- K230593 — Victan
- K230909 — EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22)
- K230958 — First Glove Blue Nitrile Examination Gloves Powder Free
- K230601 — Blue Nitrile Examination Gloves Powder Free
- K203599 — Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System
- K213289 — Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs
- K222606 — V-HYADASE
- K222640 — Sweden & Martina Surgical Trays
- K223096 — Dark Star Deformity Pedicle Screw System
- K223329 — Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)
- K223626 — Niti-S Biliary Speed D Stent
- K223651 — Cerebral Adaptive Index (CAI) Algorithm
- K230044 — Pre-Sure
- K230065 — VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System
- K230111 — CORE 500 Digital Stethoscope
- K230263 — Finesse Injectable PTA Balloon Dilatation Catheter
- K230316 — FlexBand; FlexPatch; FlexBand Plus
- K230557 — Eclipse Treatment Planning System (v18.0)
- K230580 — Diode Laser System
- K230679 — WellsForm Tricuspid Annuloplasty Band (WF)
- K230739 — Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200
- K230851 — Kodiak Lumbar Spacer System
- K231184 — CD Horizon Spinal System
- K231233 — Identity Imprint CR KRS and Identity Imprint PS KRS
- K213256 — ThermoTK
- K220759 — Armis VeriCyn Wound Wash
- K222229 — Advanced LumFix Spinal Fixation System
- K222311 — CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System
- K222624 — KLS Martin LINOS Wrist System
- K222852 — Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
- K222891 — Dental Desensitizer
- K223491 — Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
- K223814 — Genesis ACTIVE Implant System
- K223818 — Model 9160 VitaloQUB
- K230246 — Dentis s-Clean SQ-SL Narrow Implant System
- K230258 — BB 8 Sinus Dilation Kit
- K230259 — Soreal Press, Soreal CAD
- K230273 — Saranas Early Bird Bleed Monitoring System
- K231169 — STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
- K231176 — Stingray LP Catheter
- K231229 — S-COMP Reform® POCT Navigation Instruments
- K221634 — Oxymag - Transport and Emergency Ventilator
- K222035 — Avatar Medical Software V1
- K223259 — coactiv+ Antimicrobial Wound Gel
- K223620 — Reprieve by RegenesisTM
- K223663 — SIMDA Abutment
- K230106 — General Cutting Straight
Data sourced from openFDA. This site is unofficial and independent of the FDA.