FDA 510(k) clearances — page 122
clearances on record, most recent first.
Clearances — page 122
12,101–12,200 of 175,620- K223079 — Stage
- K223098 — Bakri Essential Postpartum Balloon
- K212745 — ORAcollect®Dx
- K220332 — uMR Omega with uWS-MR-MRS
- K220880 — Arthrex BioSuture
- K220949 — Architect CMV IgG
- K221322 — CUSTMBITE Snoring System
- K221420 — AlphaID At Home Genetic Health Risk Service
- K221489 — Artemis Proximal Femoral Nail System
- K222231 — S.I.N. Dental Implant System
- K222282 — HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
- K222288 — DESS Dental Smart Solutions
- K222348 — JR MEDIC
- K222505 — CurvaFix IM System
- K222514 — S.I.N. Instrument Kits
- K222601 — FilmArray Pneumonia Panel plus
- K222678 — Mobility+ Enteral Feeding System
- K222952 — 2008T BlueStar Hemodailysis Machine
- K222966 — Cirq Arm System (2.0);Alignment System Spine
- K213690 — Eclipse Blood Collection Set
- K220132 — FIREFLY® Cervical Navigation Guide
- K220823 — Preat Abutments
- K221218 — Silverlon Wound Contact, Burn Contact Dressings
- K221374 — Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
- K221885 — 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
- K222032 — NEUROMARK System
- K222047 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
- K222269 — DESS Dental Smart Solutions
- K222281 — Intracept Intraosseous Nerve Ablation System
- K222366 — EsoCheck Cell Collection Device
- K222498 — Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
- K222631 — VASSALLO GT EXT
- K222807 — TEMA Elbow system - Line extension
- K223058 — EzRay Air 2 Wall (Model: VEX-S350W)
- K223060 — DigiX FDX
- K223065 — Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices
- K223235 — Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)
- K212649 — Disposable Surgical Face Mask
- K220565 — Hudson RCI Triflo II Incentive Deep Breathing Exerciser
- K221169 — JR MEDIC Nitrile Examination Gloves Powder Free- Black
- K222070 — EndoNaut
- K222303 — Unistik® Pro
- K222365 — Leltek Ultrasound Imaging System (Model: LU700 Series)
- K222415 — Rexious Spinal Fixation System
- K222470 — 3Dicom MD
- K222968 — Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR
- K212493 — KODEX EPD System 1.5.0
- K220190 — The GIRO Growth Modulation System
- K221545 — MectaLIF Anterior Extension
- K221563 — Neurosteer EEG Recorder
- K221783 — SafetiCET Safety Lancet
- K222127 — Soft Palate Elevator
- K213804 — cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
- K222058 — Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
- K210414 — CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown
- K212391 — MCI-Neuro Fixation System
- K213128 — IntraOp VSP Software Device
- K220165 — Enteral Transition Adaptor
- K220273 — Onetouch Non-paraben Lubricant Gel
- K221022 — NextDent Ortho Flex
- K221443 — PureLift Pro Plus
- K221462 — DePuy Reclaim Monobloc Revision Femoral Stem
- K221643 — Hair Removal Device (Model: IPL-D26, IPL-D19)
- K221751 — NuVasive Cohere ALIF System Intervertebral Body Fusion Device
- K221958 — Flex-MI
- K221992 — Electronic Pulse Stimulator
- K222141 — Safety Blood Collection Needle (Without Needle Holder)
- K222199 — Collagen P.I.N. (Percutaneous Induction Needling)
- K222201 — Biological Feedback and Stimulation System
- K222215 — IPD Dental Implant Abutments
- K222270 — HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments
- K222349 — JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)
- K222632 — UHR Bipolar Implants, Restoration GAP II Implants
- K223042 — Viz LVO ContaCT
- K213106 — BTI Interna Dental Implant System UnicCa - Prosthetic Components
- K213429 — AccuSert Needle Inserter
- K213466 — Houdini Cross Support Catheter
- K214073 — eWave Monitor
- K220099 — eClinic Stethopod
- K220527 — PADnet Xpress
- K220870 — BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
- K221740 — SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448)
- K221947 — Tyber Medical Staple Fixation System (various)
- K221977 — Disposable Surgical Gown (G4003)
- K222361 — AI-Rad Companion (Musculoskeletal)
- K222404 — Evo® sEEG System
- K222547 — Electric nasal aspirator
- K222827 — da Vinci Firefly Imaging System
- K222842 — V-Patch Cardiac Monitor
- K222886 — Mercu 1717V
- K211409 — Proximerge 2 Dental Implant System
- K213742 — Infinity Pro, Logic, Quality, Sprint
- K220992 — Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
- K221029 — PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
- K221032 — Vascu-Guard Vascular Repair Patch
- K221728 — Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior Cervical Plating (ACP) System, Reflex Hybrid ACP System, UniVise Spinous Process Fixation Plate
- K221795 — STERN FIX Sternal Stabilization System
- K222643 — Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
- K222856 — SOMAVAC 100 Sustained Vacuum System
- K222890 — RADIANCE ULTRA 32 4K ZEROWIRE DUO
Data sourced from openFDA. This site is unofficial and independent of the FDA.