FDA 510(k) clearances — page 74
clearances on record, most recent first.
Clearances — page 74
7,301–7,400 of 175,620- K234073 — ICE Aspiration System
- K234092 — SafeOp 3: Neural Informatix Systeem
- K234119 — UniSpace® Stand-Alone C Cage
- K240162 — LIFEPAK® 35 AC Power Adapter (41335-000001)
- K240378 — FAQ 201, FAQ 202
- K240508 — Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
- K240534 — Bio-Medicus Life Support Catheter and Introducer
- K240753 — Miro3D Fibers Wound Matrix
- K240781 — SKOUT® system
- K230233 — Prospera Spectruum Negative Pressure Wound Therapy System
- K232325 — RAYSCAN a-Expert
- K232627 — HotDog Warming Mattress + Return Electrode
- K233850 — Difiney Anti Snoring Device
- K233924 — EMBOGUARD Balloon Guide Catheter
- K234098 — Mobility Scooter (C4+)
- K240046 — Ethylene Oxide Sterilization Supplier Change for MPO Hips
- K240085 — zLOCK Lumbar Facet Fixation System
- K240155 — Cochlear Osia System
- K240258 — Disposable Medical Face Mask (M643BE)
- K231646 — Carilex VT¿200-i NX
- K232238 — Goyo Mouthpiece S
- K233186 — uOmnispace.MR
- K233863 — TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T-
- K240032 — Celerity Chemical Indicator for enspire 3000 CLCSPS
- K240039 — Enteral Feeding Sets
- K240057 — TraumaGuard Intra-abdominal Pressure Sensing System
- K240484 — MSFX Mikron Cervical Anterior Plate System
- K240519 — Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens
- K232133 — Co2 Laser System, Models: PureLase And VanLase
- K232202 — Aperio GT 450 DX
- K232208 — Sectra Digital Pathology Module (Version 3.3)
- K232256 — Alcantara Thoracolumbar Plate System
- K233886 — Ambu® aScope Duodeno 2, Ambu® aBox 2
- K233962 — ReBorn (1050nm)
- K240748 — nextaro® v, 20/20
- K223113 — Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
- K232904 — Access Ostase
- K232926 — Novalung ultimate kit (US)
- K233411 — Folysil Silicone Catheter
- K240205 — Ez Catch Auto; Ez Catch YR; Ez Catch TR
- K240773 — VisAble.IO
- K240884 — Glide (91000-GL-X)
- K232175 — XN Knee Prosthesis System
- K222766 — Disposable Extension Set
- K232060 — TOSAMA Reusable Applicator
- K232164 — Access NT-proBNP
- K232200 — Disposable Injection Needles
- K232489 — VenusX
- K232587 — MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
- K232608 — Duo Hands-free Breast Pump
- K233034 — Mobility+ Enteral Feeding System OTC
- K233624 — HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx
- K240109 — Medical electronic thermometer (FC01, FC02)
- K240238 — Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR
- K240418 — Stryker Orthopaedics Hip Systems Labeling Update
- K240419 — UltraThineer Zirconia Slurry (5Y-B)
- K240452 — Ceramic Femoral Head
- K240571 — OASIS MRI System
- K240686 — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
- K240703 — Fine Osteotomy
- K202531 — Azer Scientific Universal Transport Medium
- K221847 — Ni2 Implant System
- K232999 — Lyric4 Hearing Aid
- K233698 — True Enhance DL
- K233757 — TitanPico Laser Workstation (PICO-450)
- K240719 — OC JuggerKnot Soft Anchor
- K240720 — TiLink-P SI Joint Fusion System
- K232409 — Electromagnetic Stimulation Systems
- K232523 — Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%
- K232641 — Neorad Pacs (Neorad Pacs)
- K233313 — Keikku Electronic stethoscope
- K233509 — Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System
- K233561 — 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
- K233789 — 8Q10 Surclear Smoke Plume Evacuation System
- K234057 — NIRVANA
- K240089 — Face Patches (MT-12MA, MT-12MC)
- K240654 — SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette
- K240744 — uMR 680
- K240760 — CELERITY HP Indicator Tape
- DEN230023 — Rho
- K232147 — CAAS Workstation
- K232599 — TransForm McCarthy Mitral Annuloplasty Ring (TF)
- K232623 — Universal Endometrial Applicator Set (GM11009840)
- K233263 — Disposable Trocars
- K233999 — GalaFLEX LITE Scaffold
- K212878 — Sample preservation solution
- K231728 — BiWaze Clear System
- K240021 — Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K240291 — EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
- K240423 — TDM Anterior Cervical Plate System
- DEN210058 — ELEOSx Limb Salvage System
- DEN220015 — Orthobond Mariner Pedicle Screw System
- DEN230032 — Symani Surgical System
- K223914 — ACTIV Cap
- K232103 — Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
- K232115 — TDM Large Bone Plate and Screw System
- K232792 — icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage)
- K232823 — MCG-S (AM1000)
- K232919 — Ambu® aScope Gastro Large; Ambu® aBox 2
- K233192 — Wireless Smart Thermometer
Data sourced from openFDA. This site is unofficial and independent of the FDA.