FDA 510(k) clearances — page 14
clearances on record, most recent first.
Clearances — page 14
1,301–1,400 of 175,620- K253132 — Single use stone retrieval balloons
- K253262 — EmeryGlide (EG18008901)
- K253538 — TeKBrace Knotless Anchor
- K253551 — VELYS Hip Navigation
- K253772 — Velocity Alpha MR High Speed Surgical Drill System
- K253951 — Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)
- K253983 — Water-based lubricant
- K260013 — CVAC Image Processor
- K260166 — Bunkerhill Contrast CAC
- K260167 — Bunkerhill Contrast AVC
- K260361 — Treace Medical Concepts (TMC) Screw Fixation System
- K251788 — Extension tube
- K251901 — Magnifico Open (100009900)
- K252196 — Arthrex FibuLock Nail System
- K252450 — Adhese 2
- K252538 — CEPHX3D
- K252779 — YUWELL® Electronic Blood Pressure Monitor (YE630CR)
- K253267 — CORIS System
- K253442 — EarliPoint Assessment
- K253591 — Phantom® Hindfoot TTC/TC Nail System
- K260169 — AV Cardiac CT
- DEN250012 — LifeVac
- K251434 — Healing Abutment System
- K252025 — Active Intramedullary (AIM) Tibial Nail System
- K253493 — Dentis SQ-SL AXEL Fixture
- K253565 — SureSmile Software
- K253870 — Electric Wheelchair (MP148)
- K253871 — Klär Lite (RCW-KL1000)
- K253878 — LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
- K253896 — TENS/EMS device (GUSE01)
- K253898 — QT Scanner 2000 Model A
- K254306 — Aevumed FENIX Suture Anchor
- K260015 — ANTERIS Thoracolumbar Plate System
- K260365 — Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char
- K260380 — Mendit
- K251793 — SOTA Cloud Smart Sensor (1.5)
- K251940 — PathLoc Lumbar Plate System
- K252534 — Surgical Face Mask (Ear mount)
- K253818 — Annalise Enterprise
- K253845 — Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
- K253874 — LED Therapy Light (COB1400, HP1800PRO)
- K253920 — CO2 Laser Treatment Machine (CFR3M1)
- K254245 — ZAFIRA®
- K260010 — TMINI® Miniature Robotic System
- K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
- K260682 — Bond-PR Universal Adhesive
- K251777 — MESI mTABLET SPIRO
- K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
- K252531 — Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)
- K252632 — Microwave Ablation Device
- K253380 — FLNT Base and FLNT Temp
- K253593 — Clarius Ejection Fraction AI
- K253771 — Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)
- K253798 — UltraPrint-Dental Hard Splint UV
- K254054 — VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System
- K254229 — Arthrex Nano FiberTak Suture Anchor
- K260003 — KARL STORZ Mediastinoscopes and Instruments
- K251998 — Atellica CH Diazo Total Bilirubin (D_TBil)
- K252448 — AViTA Pulse Oximeter (SP61)
- K252714 — C-Lant Port
- K253535 — Ligence Heart
- K253536 — Evala Nerve Stimulator (EPNR002)
- K253695 — LigaMend
- K253778 — Allday Moisturizing Rinse
- K253797 — One-Stop
- K253828 — Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)
- K253829 — Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)
- K254249 — HKT Anatomical Locking Trauma System
- K260292 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
- K251700 — Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm
- K251860 — Copioumed AAMI 3 Surgical Gown
- K252166 — RIB LINK Fixation System
- K253021 — ANNE Maternal
- K253328 — GMK 3D Metal Tibial Tray Extension
- K253578 — BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device
- K253641 — Owl Night Guard
- K253764 — ENOS Software Guided External Fixation System
- K253791 — PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid
- K254017 — SWINGO-3D Lumbar Cage System
- K254182 — Aster
- K254242 — KARL STORZ ICG Imaging System with RUBINA® Lens
- K254251 — InnovexView (GC146-17, GC150-20, GC155-23)
- K254271 — CAPRI
- K260254 — Enbio PRO
- K251687 — Konig Bell Circumcision Clamp
- K251724 — Remi Impression Material
- K253472 — FIREFLY® Pedicle Screw Navigation Guide
- K253559 — Ventana A Anterior Lumbar Interbody System
- K253789 — Electric wheelchair
- K253996 — BD Surgiphor Antimicrobial Irrigation System (910110)
- K260222 — Mako Total Knee Application
- K251678 — Swift Ray 1
- K252599 — Diode Laser Therapy Systems (WLA-02)
- K253186 — HemoSphere Nano Monitor (HSNANO1)
- K253707 — Electric wheelchair (W1,W3)
- K253714 — IntraSight Plus
- K253978 — Universal Seal (5-12 mm)
- K254055 — OSSIOfiber® Suture Anchor
- K254247 — OSTEOMNI SPINAL FIXATION SYSTEM
- K254267 — NanoPress 760A-BT (760A-BT)
Data sourced from openFDA. This site is unofficial and independent of the FDA.