FDA 510(k) clearances — page 208
clearances on record, most recent first.
Clearances — page 208
20,701–20,800 of 175,699- K191210 — Longeviti ClearFit Cranial Implant
- K192009 — LED Curing Light
- K192363 — Altapore
- K192687 — TrellOss-L MPF
- K192975 — Tyber Medical Trauma Screws
- K193433 — AMIStem-C
- K193440 — ER-REBOA PLUS Catheter
- K191489 — Genesys Spine 3DP Cervical Interbody System
- K191581 — Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device
- K192767 — Clear Aligner
- K192974 — Tyber Medical Trauma Screw
- K193024 — Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL
- K193137 — EASYGRIP FLO-41 Precision MIS Delivery System
- K190651 — ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter
- K190942 — Disposable Powder Free Nitrile Examination Glove, Pink/Black Color
- K191870 — VV330 Continuous ECG Platform, VivaLNK Adhesive Patch
- K192715 — CRF Radiofrequency Ablation System
- K192754 — Avenger Radial Head System
- K192774 — BioCardia 8F Morph DNA Deflectable Guide Catheter
- K191123 — Multi-unit Abutments
- K191642 — TK Sterile Piston Syringe without Needle
- K192412 — SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece
- K192497 — EVOL ha - D Lateral Interbody Fusion System
- K192827 — Quadra-P
- K192903 — RS85 Diagnostic Ultrasound System
- K192917 — ViewPoint 6
- K193102 — MRIaudio PREM System with MRIview
- K193125 — R2P Destination Slender Guiding Sheath
- K192696 — TriMed ASET Foot Plating System
- K181546 — Dillard Nasal Balloon Catheter
- K190243 — Z5-BL
- K190669 — Endotics
- K191056 — Conformity stem, cemented
- K191195 — PiccGuard
- K191501 — PALLAS 308/311 Solid-State UV Laser System
- K192893 — Straumann Ceramic Healing Abutments
- K193140 — Flex Body SPEEDER
- K193239 — MPowRx Snoring Solution (also known as Good Morning Snore Solution)
- K193359 — SureMAX Family of Cervical Spacers
- K193375 — NeuroBlate System
- K193431 — AlignRT Plus
- K183089 — Air Next
- K191061 — Optilume Basic Urological Balloon Dilation Catheter
- K191147 — OC-Auto SENSOR io iFOB Test
- K191446 — Ureteral Stent Systems, Biliary Drainage Catheters
- K191739 — Sterile LeadConfirm
- K191907 — OptoWire III
- K192216 — Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP
- K192457 — Elos Accurate Customized Abutment
- K192599 — ASAHI PTCA Guide Wire ASAHI Gaia Next
- K193092 — TunneLoc Tibial Fixation Device
- K193360 — Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard
- K190990 — Digital Thermometer
- K192343 — Patient Monitor
- K192444 — mCare® Powder Free Nitrile Black Examination Glove
- K192578 — InCore TMT System
- K192912 — AutoMIStar
- K193381 — RadCalc Software
- K190241 — Sterile Latex Surgical Glove, Powder Free
- K192258 — Disposable Valve Sets
- K192655 — Depuy Synthes Maxillofacial Portfolio - MR Conditional
- K191059 — Masimo Rad-97 and Accessories
- K191256 — Straumann BLX Ø3.5 mm Implants
- K191696 — Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
- K192196 — Medical Radiation Dosimetry System microSTARii
- K192695 — InMode System with the Morpheus8 (Fractora) Applicators
- K192700 — Xcam
- K192939 — Volumetric Specimen Imager
- K193149 — True 3D Viewer Software
- K193403 — UroNav System
- K190467 — iHelmet Hair Growth System
- K190884 — TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
- K192768 — Temporary Fixation Pins
- K193050 — Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem
- K192135 — VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33)
- DEN180067 — Mucosal Integrity Conductivity (MI) Test System
- K182718 — Mini and Micro Fragments Reconstruction System GMReis
- K190665 — Neodent Instrument Kit Cases
- K190736 — Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs
- K190860 — Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color
- K191551 — RIST Cath Radial Access Long Sheath
- K191846 — MAXReach Laser Probe
- K191960 — Arthrex Univers Revers Modular Glenoid System
- K192023 — Arm Blood Pressure Monitor
- K192104 — Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs)
- K192485 — BioCode Respiratory Pathogen Panel (RPP)
- K192487 — EZ-TRAX Containment Device
- K192645 — Trigon Ti Stand-Alone Wedge Fixation System
- K192733 — RelieforMe TENS/EMS Device Model UPK-GE01
- K193254 — 3M Attest Steam Chemical Integrator
- K193279 — Comet II Pressure Guidewire
- K192559 — Acetabular Bone Screws (for MobileLink Acetabular Cup System)
- K192629 — Spinalytics
- K183213 — IceSense 3, ProSense, MultiSense
- K190008 — Carescape One
- K190112 — Non-Sterile Zirconia Block
- K190284 — Bengal Stackable Cage System
- K190633 — NanoOrtho NanoKnee® System
- K190730 — IODOSORB
- K190756 — IODOFLEX
Data sourced from openFDA. This site is unofficial and independent of the FDA.