FDA 510(k) clearances — page 112
clearances on record, most recent first.
Clearances — page 112
11,101–11,200 of 176,479- 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
- 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) +1 more
- 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 (3 models)
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.