FDA 510(k) clearances — page 23
clearances on record, most recent first.
Clearances — page 23
2,201–2,300 of 175,620- K251191 — Collagen Dura Regeneration Membrane - Repair
- K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75)
- K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)
- K252281 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
- K252521 — LifeStyles® HydraFeel Natural Rubber Latex Condom
- K252550 — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
- K252582 — Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems
- K252636 — Fluido Compact System
- K252729 — Universal Spinal System
- K252818 — Dexcom Smart Basal
- K253411 — Miniature Telescope for Urology (27033AA)
- K253423 — ToeJack MIS Bunion System
- K250588 — Access Rubella IgG
- K251141 — Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K251566 — TS-RF Generator (STS10)
- K252086 — DTX Studio Assist
- K252330 — DeepRESP
- K252792 — PM2 System with ECGuide Connector
- K253487 — ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System
- DEN250015 — Neurolyser XR (NXR100)
- K250471 — AquaC UNO H
- K250501 — System Sophi
- K250525 — Second Opinion® Panoramic
- K250865 — KLS Martin IPS Forearm System
- K251078 — AutoDensity
- K251538 — Status COVID-19/Flu A&B
- K251659 — Mesh Nebulizer (H6)
- K251756 — Sterilization Trays
- K251821 — ARC-EX System
- K251872 — Biomoneta Avata Rx
- K252618 — IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)
- K252627 — Lyme-ID IgG Test; Bio-ID800
- K251314 — Rosa® Knee System
- K251662 — Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507)
- K251842 — Dental Computed Tomography X-ray System
- K252308 — LED Beauty Mask (RLBXX)
- K252592 — TELLTALE Electrosurgical Guidewire System
- K252949 — Geminus Volar Distal Radius Plating System
- K253457 — ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System
- K243715 — Synthes Patient Specific Implants
- K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
- K251336 — VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA)
- K251833 — EMPOWR Acetabular® Liner Extension
- K252271 — Hemoclip
- K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments
- K252452 — PeekMed web
- K252829 — Powered Wheelchair (PL001-9001)
- K252959 — WRISTAR MultiAx Distal Radius Kit
- K253290 — XSTAT P15
- K251006 — NeVasc Aspiration System
- K251702 — IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )
- K252287 — Symani Surgical System
- K252474 — Withings BeamO (SCT02)
- K252560 — Atlas Spine HiRISE Expandable Cervical Corpectomy System
- K252570 — EzSensor HD, EzSensor UHD
- K252573 — KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
- K251596 — Lunderquist Extra Stiff Wire Guide
- K243131 — Triathlon Pro
- K250264 — SugarBug (1.x)
- K250739 — Primeprint Direct Aligner
- K250819 — Electric Wheelchair (Rollz Motion Electric 2M)
- K251129 — S.I.N. Tapered Pro Conical Zygoma Implant System
- K251295 — ulrichINJECT CT Motion (XD 8000)
- K251391 — BrainsWay Deep TMS System
- K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
- K251853 — Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System
- K252041 — Fibresolve (with PCCP)
- K252519 — CO2 Laser Therapy System (K106)
- K252564 — Medical Diode Laser Systems (VeinCure)
- K253039 — AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
- K253513 — MultiMatch Flow Chameleon AntiMicrobial Composite
- K250423 — mb-FIX Cranial Stabilization Systems
- K250815 — Hubly Drill (H100)
- K251004 — Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
- K251555 — Ultra Compression Screw System
- K251792 — Stereotaxis GenesisX RMN with Navigant Workstation (NWS)
- K252133 — Adaptix Ortho350
- K252418 — Catalyst F1x Shoulder System
- K252469 — MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA
- K252515 — Q-Switched Nd:Yag laser (K690)
- K252525 — AIO Breathe
- K252845 — Venus Nova (FP-2001)
- K253074 — Tandem Mobi insulin pump with interoperable technology
- K253265 — BriefCase-Triage
- K253478 — Motive Muscle Stimulator for Lower Back (OT01-1003)
- K250363 — Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept
- K250375 — Allure Hip Stem and Intramedullary Plugs
- K250376 — ViVY
- K250599 — ExcelsiusGPS Instruments
- K252514 — EVAC-MRI
- K252677 — Polyshield Safety IV Catheters
- K250241 — Cios Select
- K250576 — Flexx Junior (FLX-J00, FLX-J50)
- K250853 — Merit Syringe
- K251303 — Tamburo Thulium Fiber Laser System
- K251410 — VXvue
- K251709 — MedCAD® AccuStride System
- K252664 — GMReis Suture Anchors
- K252740 — Voyant® Open Fusion Device (EB240/Open Fusion)
- K252964 — PRIMED Surgical and Procedure Masks
Data sourced from openFDA. This site is unofficial and independent of the FDA.