FDA 510(k) clearances — page 59
clearances on record, most recent first.
Clearances — page 59
5,801–5,900 of 176,479- K243452 — Orthoscan VERSA Mini C-Arm
- K243577 — Radical the Dude 8F Guide Catheter
- K243904 — Elegance® Anterior Cervical plate
- K233452 — Vivo 45 LS
- K241059 — Pantheon Proximal Femur Reconstruction (PFR) System
- K241200 — SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
- K241431 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)
- K242030 — MegaGen Dental Implant Abutment
- K242680 — LetsGetChecked Impress
- K242689 — AAMI Level 4 Protective; Gown
- K243262 — QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test
- K243271 — MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer +2 more
- K243295 — Initia Knee System
- K243527 — High Flow Insufflation Unit (UHI-4)
- K243533 — Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus
- K243791 — Air Pressure Therapy System
- K243890 — Arthrex Intramedullary Nails
- K243909 — Precision1 +5 more
- K243950 — ARVIS® Shoulder
- K243836 — Mentor CPX 4 PLUS Enhance Breast Tissue Expander
- K241641 — Electric Wheelchair (YE200)
- K240267 — Klaxon (Twist); Klaxon (Twist R)
- K241009 — PeriCALM Patterns 3.0
- K241064 — Unscented Tampon
- K241174 — INTRABEAM (700) +1 more
- K241676 — TriVerity
- K241764 — Mould Probe MR Safe
- K241781 — Solo Pace Control
- K241891 — ScreenDx
- K242071 — Xpert Xpress CoV-2/Flu/RSV plus
- K242228 — Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)
- K242366 — OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment
- K242528 — Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)
- K242767 — Safecare Urinary Tract Infection Test
- K242877 — BioCode Gastrointestinal Pathogen Panel (GPP)
- K242901 — ZZIREN Orogastric Tube +6 more
- K243111 — Bowhead ERA Wheelchairs
- K243195 — Arthrex SS VAL and VAL KreuLock Compression Screw System
- K243477 — Universal Tendon Spacer
- K243492 — Ulike Reglow Light Therapy Device (UM10)
- K243806 — Safety Winged Blood Collection Sets
- K243811 — Erchonia Zerona® VZ8
- K243814 — NuVasive Pulse System
- K241273 — FullFocus
- K242805 — Dental Cone-beam Computed Tomography (FinScan F350)
- K240590 — Electrical Scooter, WT-T4SU
- K241003 — HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
- K241489 — ReminGel
- K241806 — Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel
- K242043 — Sperm Freezing Medium
- K242290 — DormoTech NLab
- K242661 — TRI-matrix® X-Force Implants
- K242741 — ACE Cannula
- K242842 — ANNE View, Central Hub
- K243644 — Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)
- K243813 — QIAstat-Dx GI Panel 2 Mini B&V
- K243818 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
- K241079 — uCT 780
- K241456 — GlutenID Celiac Genetic Health Risk Test
- K241808 — ApolloHipX (THR.SS.0001)
- K242019 — GXR-Series Diagnostic X-Ray System
- K242588 — COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)
- K243259 — MASADA Modular Spinal Fixation System
- K243335 — Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
- K241904 — DermiSphere Dermal Template
- K242123 — Brainomix 360 e-CTA
- K242139 — Mobility Scooter (YL-09B, YL-07)
- K242488 — Soteria E-View
- K242499 — Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))
- K242753 — SD TL Implant System
- K242760 — WHILL Model R
- K243466 — Conformity Stem Extension Line, #0
- K243481 — TMINI Miniature Robotic System
- K233118 — DUET-V (Model: ESK-3261DV)
- K233419 — GBR System
- K240346 — NobelProcera Zirconia Implant Bridge
- K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System
- K241283 — Elemental Granulate
- K241350 — Clarify DL
- K241757 — syngo.CT Dual Energy
- K242110 — PENTAX Medical Video Colonoscope (EC38-i20cWL)
- K242119 — INNOVISION-EXII
- K242578 — EVOLVE Nitric Oxide Delivery System
- K242726 — Synapsys VHIT
- K243363 — JLK-ICH
- K243737 — Inbella RF System
- K250015 — Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive
- K241005 — Haemostasis Clips
- K241388 — Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter
- K241568 — CrystLCare PRO Biorestorative, Fluoride-Plus
- K241696 — Ortho AI
- K242326 — Wave Electrode (AE02-60); Wave Electrode (AE02-50)
- K242334 — Ezra Flash
- K242448 — Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)
- K242789 — Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)
- K243049 — Pulse Oximeter (3 models)
- K241338 — Peak Flow Meter
- K241852 — Nasal Aspirator (NS 13)
- K242468 — Power Wheelchair (D10, D12, D15, D17, D20, D37)
- K242989 — Electric Wheelchair (MODEL H)
Data sourced from openFDA. This site is unofficial and independent of the FDA.