FDA 510(k) clearances — page 93
clearances on record, most recent first.
Clearances — page 93
9,201–9,300 of 175,620- K221860 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
- K222610 — Elecsys Anti-Tg
- K223788 — The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
- K223812 — Sensis Vibe (VD15)
- K223857 — i-STAT G3+ cartridge with the i-STAT 1 System
- K230066 — Carnation series Diagnostic Ultrasound System
- K230332 — Ambu® aScope Colon; Ambu® aBox 2
- K230752 — Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)
- K230946 — Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L
- K230974 — NIDO Pedicle Screw System
- K231235 — LW UCLA Abutment
- K231242 — Perifix FX Catheter; Contiplex FX Catheter
- K231336 — T2 Biothreat Panel
- K231791 — PENTO Nd:YAG and Alexandrite laser system
- K231827 — BTI Dental Implant System UnicCa® Aesthetic Post Abutments
- K232102 — ClearPoint Array System (Version 1.2)
- K232121 — Power wheelchair (Model:BC-EA8000)
- K232198 — Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF)
- K232199 — Bariatric Heavy Duty Wheelchair (YJ-010B 20DS; YJ-010B 20DE; YJ-010B 20DFS; YJ-010B 20DFE;YJ-010B 20ADS; YJ-010B 20ADE; YJ-010B 20ADFS; YJ-010B 20ADFE; YJ-010B 22DS; YJ-010B 22DE; YJ-010B 22DFS;YJ-010B 22DFE; YJ-010B 22ADS;YJ-010B 22ADE; YJ-010B 22ADFS; YJ-010B 22ADFE; YJ-010B 24DS; YJ-010B 24DE; YJ-010B 24DFS; YJ-010B 24DFE; YJ-010B 24ADS; YJ-010B 24ADE; YJ-010B 22ADFS; YJ-010B 24ADFE)
- K232315 — Catalyst Bone Void Filler
- K232508 — Barrier EasyWarm Active Self-Warming Blanket
- K220034 — NEUROShield
- K223833 — Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
- K223869 — ChoiceSpine Blackhawk Ti Cervical Spacer System
- K223885 — HOPKINS Telescopes
- K230108 — Straumann® BLC and TLC Implants
- K230167 — BACK 4
- K230237 — Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)
- K230526 — TEA Device
- K230746 — Non absorbable Surgical Polypropylene Suture
- K230775 — SOFIA EX Intracranial Support Catheter
- K230959 — VitreJect® Needle; OcuSafe® Needle
- K230987 — FlowStar Analog Mixer Flowmeter
- K231030 — Cove Putty, OsteoCove Putty
- K231079 — LW Retraction Cap
- K231147 — Hammerdesis Interphalangeal Fusion System
- K231353 — AccuCTP Pro
- K231484 — PureWay 1.4 Quart Sharps Collector
- K231576 — cNeuro cPET
- K232124 — IPL Hair Removal, Model: W-1095, W-1098
- K232146 — Anovo Pedestal
- K232189 — OrionXR
- K232462 — ThermPix Thermovisual Camera
- K232467 — CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
- K232487 — Provecta 3D Prime and Provecta 3D Prime Ceph
- K232827 — LightForce Orthodontic System
- DEN230021 — ensoETM
- K221640 — AlloMap Heart Molecular Expression Testing
- K222831 — CRYOcheck Factor VIII Deficient Plasma with VWF
- K223811 — Lung-CAD
- K230609 — NG Delivery Catheter
- K230735 — Ultimate rTMS; Yingchi rTMS
- K230750 — OSSIOfiber® Cannulated Trimmable Fixation Nail
- K232158 — GenX-CR
- K232485 — AMSCO 600 Steam Sterilizer
- K213767 — Endure ETCO2/02 Nasal Cannula
- K222938 — Ablation-fit
- K230598 — Stone Extraction Baskets
- K231011 — Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse
- K231112 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- K231317 — TrueBeam, TrueBeam STx, Edge, VitalBeam
- K231748 — Cartesion Prime (PCD-1000A/3) V10.15
- K231766 — Skyway Anterior Cervical Plate System
- K231892 — Definium Pace Select
- K232459 — Velacur
- K232526 — XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
- K223755 — i-STAT G cartridge with the i-STAT 1 System
- K230362 — Planar LED mate
- K230517 — Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)
- K230881 — Change Healthcare Cardiology Hemodynamics
- K231283 — SiteRite 9 Ultrasound System
- K231504 — TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System
- K231746 — VERIFY Spore Test Strip for S40 Sterilant Concentrate
- K232002 — Vantage® Total Ankle System
- K232154 — MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
- K232192 — Venus Versa PRO System
- K223864 — Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
- K213510 — IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA
- K222921 — Minuteful-kidney test
- K223621 — DeepXray
- K223827 — FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
- K223848 — Intrisound Tuned Lumen® 155 Hearing Aids
- K230310 — STAT Medical Device Lancing System
- K230372 — VitreJect Syringe
- K230535 — KARL STORZ Urological Laser Accessories
- K230661 — Zeta Cranial Navigation System
- K230890 — ISE Electrodes
- K231141 — STarFix Designer Software C0265
- K231146 — AliTight
- K231240 — MaxTack Motorized Fixation Device
- K231284 — OnPoint Augmented Reality Spine System
- K231335 — Cleerly ISCHEMIA
- K231471 — Air/Water Bottle Tubing, CO2 Source Tubing
- K231643 — Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
- K231720 — Sterile Hypodermic Needles for Single Use
- K231723 — Sterile Safety Hypodermic Needles for Single Use
- K231727 — Sterile Auto-Disable Syringes with/without Needle for Single Use
- K231729 — Sterile syringes for single use with/without needle
- K232166 — PreXion3D Expedition
- K232386 — ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6
Data sourced from openFDA. This site is unofficial and independent of the FDA.