FDA 510(k) clearances — page 38
clearances on record, most recent first.
Clearances — page 38
3,701–3,800 of 176,479- K252528 — Ion Endoluminal System (IF1000)
- K243700 — Apollo TMS Therapy System
- K243789 — LIBERTY Endovascular Robotic System (LIBERTYOS)
- K250064 — Dose+ (1.0)
- K250353 — Oniris; Oniris Plus
- K250770 — Optina-4C (MHRC-C1N)
- K250893 — Ball Joint Guide Array (66295)
- K251168 — Image Suite
- K251298 — Mobile Laser Unit (1001-N2) +3 more
- K251438 — Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
- K251444 — Endoskeleton Interbody Systems
- K251463 — EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01) +1 more
- K251510 — Symani Surgical System
- K251533 — Rapid Obstructive Hydrocephalus, Rapid OH
- K251545 — Intense Pulsed Light Therapy Device (MMABM-1)
- K251656 — Careverse CoronaryDoc (Careverse CoronaryDoc)
- K251733 — Fluido® AirGuard System
- K251737 — NextAR(TM) Shoulder Platform
- K251781 — KALA MINI 2.0 (KALA-04)
- K231952 — MEDILIGHT
- K250217 — AGNES Ultra
- K250231 — Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)
- K250765 — AViTA Arm Type Blood Pressure Monitor Cuff
- K251457 — Diode laser therapy device (VADER)
- K251575 — IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System
- K251726 — SignalNED System (Model RE)
- K251909 — NeurotriS (SX2500); NeurotriS (SX3800)
- K252174 — AquaCast Mask
- K252446 — BruxZir® NOW
- K252454 — Kinos Total Ankle System
- K252539 — Tempus Pixel
- K242768 — Customized Abutment and Screw
- K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
- K250753 — VELMENI for DENTISTS (V4D)
- K251408 — OsteoSight Hip (v1)
- K251615 — Aerogen Pro-X1 Controller System
- K251775 — RODIN Cement
- K251975 — Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component
- K243745 — FG Bone Graft B
- K243799 — Fetal Pillow
- K243859 — PRAEVAorta®2
- K250003 — GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
- K250285 — NEUROVENT-P (092946-003) +15 more
- K250290 — SurgiTwin
- K250335 — IVA & AEON Cervical and Lumbar Cage System
- K250771 — Primescan 2
- K250874 — Sunrise
- K250939 — SIRIUS Endoscope System (PR-SI-1230)
- K251026 — Regenesis EMS Chair
- K251106 — Sonosite LX and Sonosite PX Ultrasound Systems
- K251108 — Erbe ESU Model VIO® 3n with Accessories
- K251181 — Splashwire Hydrophilic Guide Wire (6 models)
- K251217 — SmartGuard technology; Predictive Low Glucose technology
- K251324 — da Vinci SP Surgical System (SP1098)
- K251480 — PV01 PVDF Effort Sensor
- K251718 — ArTT Augments and Buttresses and Bone Screws
- K251727 — GLAM LED Facial Mask (TB-2386F)
- K251814 — EZ IV Administration Set
- K251946 — G aenial Universal Injectable II
- K252019 — CurvaFix Low Profile System
- K252364 — Edwards eSheath Optima introducer set
- K252380 — Invisalign System
- K252392 — Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set
- K243767 — SV600, SV800 Ventilator
- K243901 — SmartPilot YpsoMate NS-A2.25
- K250148 — Medical Gas Analyzer (AG200)
- K250788 — Definium Tempo Select
- K251429 — OTC 4-Channel Rechargeable TENS Unit
- K251484 — CT:VQ
- K251594 — truFlex
- K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)
- K252014 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
- K252030 — RadiForce GX570; RadiForce GX570-AR
- K252057 — Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System
- K252350 — da Vinci SP Firefly Imaging System
- K252383 — Somfit D
- K252411 — JARVIS Glenoid Reverse Shoulder Prosthesis
- K252437 — JAZZ Spinal System
- K252505 — Powder-Free Vinyl Exam Gloves, clear
- K241766 — QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
- K241882 — Fetal & Maternal Monitor (F15A, F15A Air)
- K243166 — Dermalage
- K243687 — Vital Signs
- K243774 — ELID (Endoscopic Less Invasive Decompression) System
- K250080 — QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini
- K250625 — Portable oxygen concentrator (W-R1(MAX)) +3 more
- K250947 — VistaSoft 4.0 and VisionX 4.0
- K251068 — KnoxFog Anti-fogging Device
- K251382 — Phoenix Sinus Tarsi Stent System
- K251415 — Additively Manufactured Aligner Resin
- K251637 — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA] +1 more
- K251716 — Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
- K251752 — Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)
- K252118 — CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup
- K252419 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
- K244061 — X-Wire Guidewire
- K250049 — Medical Video Endoscope [Standard Deflection] (URS3005) +6 more
- K250261 — Heager Medical Laser Family (Sabrina/Adolf)
- K251305 — Ultra-Fast Vitri; Ultra-Fast Warm
- K251983 — Brainomix 360 Triage Stroke
Data sourced from openFDA. This site is unofficial and independent of the FDA.