FDA 510(k) clearances — page 29
clearances on record, most recent first.
Clearances — page 29
2,801–2,900 of 175,620- K250734 — OptiLUV Device
- K251573 — VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens
- K251817 — da Vinci SP Surgical System (SP1098)
- K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full
- K252527 — Surfacer Inside-Out Access Catheter System
- K252530 — OptiVu Shoulder
- K252580 — iQ200 Series
- K243846 — Access anti-HAV
- K250483 — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation
- K250922 — Edema Guard Monitor (EGM) CardioSet-001
- K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test
- K251072 — Segmentron Viewer
- K251682 — MuscleView 2.0
- K251773 — Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin Gel Caramel flavor lubricant; Satin Gel Peach flavor lubricant; Satin Gel Strawberry flavor lubricant.)
- K251891 — Electric Wheelchair (GY-E001)
- K252180 — Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)
- K252181 — AquaA
- K252477 — Hybrid Viewer (00859873006240)
- K252524 — Quadsense (Quadsense and Quadsense Pro)
- K252608 — AI-Rad Companion Prostate MR
- K250229 — Dual Action Tissue Closure Device
- K250928 — OmniTom Elite with PCD
- K250960 — DUO Microcatheter
- K251227 — da Vinci Surgical System (IS5000)
- K251394 — Momcozy Wearable Breast Pump (BP223)
- K251610 — qER-CTA (v1.0)
- K251754 — Wearable Breast Pump (Model S33)
- K251892 — MAXXOS P.A.C.E. Foot & Ankle Plating System
- K251931 — BioTraceIO Vision (V1.7)
- K251957 — Coaptium Connect with Tissium Light
- K243795 — pREBOA-PRO Catheter
- K244038 — High Pressure Tubing
- K250095 — All-Suture Dual Anchor System
- K250132 — Ureteral Access Sheath
- K250460 — WatchPAT400 (WP400)
- K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL
- K251022 — 3D-SHAPER
- K251250 — ViewMate Multi Ultrasound System (VMM-ICE-01); ViewMate Multi Ultrasound System (VMM-ICE-02)
- K251317 — SOLOPASS 2.0 System
- K251753 — GenaCheck COVID-19 Rapid Self-Test
- K252478 — Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port
- 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); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)
- 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); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)
- 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); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL
- 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 (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT)
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.