FDA 510(k) clearances — page 176
clearances on record, most recent first.
Clearances — page 176
17,501–17,600 of 175,699- K202574 — LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
- K202687 — Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60
- K203426 — Surgical Face Mask (non-sterile)
- K210136 — PhantomMSK Hip
- K210137 — EsoCheck Cell Collection Device
- K210329 — Green X 18(Model : PHT-75CHS)
- K202338 — SpaceFlex Shoulder
- K202401 — Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein
- K203307 — VIOLA
- K203399 — FITBONE(R) TAA
- K210132 — s-Clean SQ-SL Implant System Regular
- K210252 — iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System
- K200626 — VesselIQ Xpress
- K201391 — Easytech® Anatomical Shoulder System
- K201732 — Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On
- K203312 — Vitrea Software Package, VSTP-001A
- K203419 — Relivion
- K203670 — Extra Large Check-Flo Introducer
- K210035 — ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System
- K210114 — Rebar Micro Catheter
- K210234 — cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
- K210443 — PLPT LDV (Low Dead Volume) Sterile Syringe
- K210444 — EZ-Injec LDV Sterile Safety Needle
- K200160 — 740 SafeSAT
- K192742 — Straumann Variobase C
- K193280 — MedCAD® AccuPlate® Patient-Specific Plate
- K200551 — MectaLIF Transforaminal TiPEEK
- K201356 — Plastic LOR Syringe
- K201490 — Electro Flo 6 Airway Clearance System
- K201545 — Surgical Face Mask
- K201628 — Panda iRes Warmer, Giraffe Warmer
- K201799 — CleaniCal
- K202281 — EDS Bioceramic Sealer (Bioseal)
- K202341 — Disposable Surgical Mask
- K202368 — Infrared Thermometer
- K202611 — Catalyst OrthoScience R1 Reverse Shoulder System
- K202651 — NOA Sleep Apnea and Snoring Device
- K203091 — MucoLock Oral Gel
- K203191 — LYDUS Nitrile Examination Gloves, Powder Free
- K203355 — Straumann TLX Novaloc and Cementable Abutments
- K203546 — gammaCore Sapphire
- K203702 — Vinyl Examination Gloves (Yellow)
- K203740 — JuggerKnot Soft Anchor
- K203766 — 4D Integrated Treatment Console
- K192839 — DSP Implant System
- K193662 — Ezlymph, Ezlymph M
- K201222 — Bio-C Repair Ion+
- K201292 — TRAUS SIP20
- K202219 — VORTRAN GO2VENT with PEEP Valve
- K203385 — TenoTac Soft Tissue Fixation System
- K210089 — CATSmart, Automated Blood Processing Autotransfusion System
- K191897 — Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)
- K200675 — Hi bebe super (Models BT-150S and BT-150L)
- K201332 — Meditech ABPM-06 (BP6)
- K201454 — DSG Connect Technology
- K201536 — Infrared Forehead Thermometer
- K202174 — Digital NeuroPort Biopotential Signal Processing System
- K202605 — Standard Procedure Mask, Standard Surgical Mask
- K203490 — FORE-SIGHT ELITE Absolute Tissue Oximeter
- K203513 — SLENDERTONE Evolve Abs, Type 735
- K203557 — EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing
- K203632 — da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments
- K201583 — SmartCT R1.0
- K202850 — Concerto Versa, Detachable Coil
- K203055 — Stryker PEEK Customized Cranial Implant Kit
- K203079 — MR Conditional Sticky Pad Electrode
- K203103 — Synapse 3D, Synapse 3D Base Tools v6.1
- K203265 — nPro Surgical Mask
- K210083 — Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7
- K210272 — LIAISON Anti-HAV
- K202942 — Straumann 4 mm Short Implants
- K203069 — HydroMID
- K200276 — SPEAC System
- K201635 — MouthLab Vital Signs Monitoring System
- DEN200018 — eXciteOSA with remote and eXciteOSA without remote
- K200320 — Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload
- K200368 — LINK Embrace Shoulder System - Reverse Configuration
- K200470 — Shofu Block HC Hard
- K201121 — Sphincterotome
- K201306 — HAMILTON-C3
- K201324 — Antibacterial Bandage
- K201421 — Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons
- K203290 — Bonelogic
- K203302 — GentleWave X
- K203319 — SYMPHONY OCT System
- K203334 — The Citrefix Knotless Suture Anchor
- K203374 — X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)
- K203475 — LimaCorporate Kirschner Wire
- K203588 — ELEOS Limb Salvage System
- K203635 — Patient Monitoring Cables
- K210036 — Carnation Ambulatory Monitor (CAM)
- K210053 — LVivo Software Application
- K210054 — Cios Spin
- K210055 — Cios Alpha
- K210063 — Freudenberg Surgical Mask
- K202493 — Medical Face Mask
- K202872 — Prase PEEK Anterior Cervical Interbody Spacer
- K203573 — RESPONSE Navigation Instruments
- K203582 — QUIBIM Precision Prostate (qp-Prostate)
- K210174 — BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set
Data sourced from openFDA. This site is unofficial and independent of the FDA.