FDA 510(k) clearances — page 100
clearances on record, most recent first.
Clearances — page 100
9,901–10,000 of 175,620- K223806 — VERTICALE® Triangular Fixation System
- K230173 — Servo-air Lite Ventilator System
- K230510 — MyEllevate
- K230968 — VYBE RF Electrosurgical System
- K231003 — Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)
- K231339 — Tyber Medical Pin and Wire System (various)
- K231568 — HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
- K220980 — Tissue Approximation System (TAS)
- K221058 — LungTrainer (MD2 & MD3)
- K222015 — Integral Titanium Cervical Interbody
- K230001 — Electric Scooter (Model: M2020)
- K230864 — VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin
- K231279 — Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm
- K231358 — Universal Seal (5-12 mm)
- K231641 — Rotium Bioresorbable Wick
- K231740 — MemorialTM Gloves
- K221664 — CLEARinse CTS Specimen Collection and Transport System
- K222745 — Axial3D Insight
- K230025 — IVYLASER Handhold Hair Removal Machine
- K230487 — Dental Lithium Disilicate Glass-Ceramic
- K230569 — Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )
- K230720 — LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
- K230901 — Premier HpSA Flex (619096)
- K231280 — CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement
- K231653 — BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter
- K230725 — NB Implant System
- K212409 — Ulspira TS Nitric Oxide Therapy System
- K213253 — Pixyl.Neuro
- K221294 — preCARDIA Occlusion System
- K222466 — AirTom
- K223135 — AblatePal Radiofrequency Ablation System
- K223374 — Blood Pressure Monitor
- K223694 — Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)
- K223854 — Unistik® ShieldLock, Unistik VacuFlip
- K230052 — Inogen Rove 6
- K230156 — 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
- K230456 — SGM Femoral Nail System
- K230469 — Compact Wearable Pump
- K230917 — FebriDx Bacterial / Non-bacterial Point of Care Assay
- K230930 — enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
- K230933 — REMI Remote EEG Monitoring System
- K230935 — Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)
- K230944 — MeMed BV
- K230991 — PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
- K231252 — Ventana L Spinal System
- K231264 — Easy On Universal Glaze & Stain
- K231267 — ClearTip
- K231585 — Vantage PSI System
- K231588 — ViewFlex Eco Reprocessed ICE Catheter
- K231596 — IOB Temperature Management System
- K231689 — iFuse TORQ® Implant System
- DEN200052 — KidneyIntelX.dkd
- K221436 — F&P 950 Accessory Breathing Circuit Kits
- K222933 — MYAH
- K223047 — NeuroSwift Pro
- K223596 — SQ.line KERRISON
- K230176 — Upper Arm Blood Pressure Monitor
- K230337 — EarliPoint
- K230374 — Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)
- K230595 — OsteoCentric ACL Fixation System
- K230866 — HotDog Warming Mattress + Return Electrode
- K231101 — Flume Catheter
- K231549 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
- K231553 — OverStitch NXT Endoscopic Suturing System
- K231647 — XENOVIEW 3.0T Chest Coil
- K231691 — Phantom XL Insulated Dilators
- K210924 — e-Celsius Medical System
- K213652 — Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)
- K220198 — Medi Lift PLUS
- K223722 — MIO Blood Glucose Monitoring System
- K230075 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K
- K230859 — Aneroid Sphygmomanometer
- K231232 — Curiteva Laminoplasty System
- K213046 — AceConnex Pre-Sutured Fascia
- K222492 — Hope&Her Vaginal Dilators
- K223100 — Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
- K230706 — EMBOLD Soft Detachable Coil System
- K230861 — VADER® Pedicle System Navigated Instruments
- K230876 — RI.KNEE Adjustable Tibia Cut Guide
- K231124 — Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)
- K231219 — NobelZygoma PureSet Tray
- K231636 — LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
- K221488 — Z7 Zirconia Implant System
- K222378 — VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)
- K223138 — AB1 Electrosurgical Instrument, Creo Electrosurgical System
- K223143 — SAGICO Spinal System
- K230492 — Avitus® Precision Autograft Delivery System
- K230867 — Bone Bolt System
- K230914 — ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)
- K231215 — IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S
- K222142 — BR SLA Type Implant System
- K220955 — Hudson RCI Variable concentration Large Volume Nebulizer (1770)
- K221411 — Surflo Winged Infusion Set
- K221827 — Mais Central Venous Catheter
- K222323 — Black Diamond
- K222592 — AltiVate® Anatomic Shoulder AG e+ with Markers
- K222969 — FERTI-LILY Conception Cup
- K222982 — Virtus Metabolic Monitor
- K223013 — AccurECG Analysis System
- K223019 — sam 2.0 Long Ultrasound Device
Data sourced from openFDA. This site is unofficial and independent of the FDA.