510(k) Clearances in 2021

3,023 510(k) clearances total

Browse FDA 510(k) clearances granted in 2021. RegDataLab tracks 3,023 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2021 (page 1 of 61)
510(k) clearancesDetails
K212547 — Quick-Start ScrewsInnovate Orthopaedics Limited Dec 30, 2021
K213538 — Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. Dec 30, 2021
K202898 — Tzoar 207 Negative Pressure Wound Therapy (NPWT) SystemLightstone Medical Products (Ningbo) Co, Ltd. Dec 30, 2021
K211458 — Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting StaplersNingbo Verykind Medical Device Co., Ltd. Dec 30, 2021
K211159 — eco-x Series (eco-x, eco-x-s)Hdx Will Corp. Dec 30, 2021
K212834 — Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)Siyang Threeguard Medical Supplies Co., Ltd. Dec 30, 2021
K211263 — IntreliefEasymed Instruments Co., Ltd. Dec 30, 2021
K202101 — GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2Accriva Diagnostics, Inc. Dec 29, 2021
K213073 — Goody Gloves, Wincare, TBG GlovesThai Rubber Gloves Co., Ltd. Dec 29, 2021
K211156 — CONVIVO In Vivo Pathology SuiteCarl Zeiss Meditec, AG Dec 29, 2021
K213316 — Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEMNihon Kohden Corporation Dec 29, 2021
K213776 — LiverSmartResonance Health Analysis Services Pty, Ltd. Dec 29, 2021
K212656 — Flexible Intubation Video Endoscope – Sterile (FIVE-S)Karl Storz Endoscopy America Dec 29, 2021
K213209 — EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment DeviceK1 Medical, LLC Dec 28, 2021
K213016 — ATM GlovePhu Duc Huy Production Trading Services Corporation Dec 28, 2021
K212806 — Alcon (serafilcon A) soft contact lenses for daily wearAlcon Laboratories, Inc. Dec 28, 2021
K213763 — Sonosite PX Ultrasound SystemFUJIFILM Sonosite, Inc. Dec 27, 2021
K193138 — Colibri SystemCopan Wasp Srl Dec 27, 2021
K212848 — Sterile Latex Surgical Gloves Powder FreePentavest Holdings Sdn Bhd Dec 27, 2021
K212716 — Dermoaroma Disposable Nitrile Examination GloveChuzhou Harmony Gloves Medical Technology Co.,Ltd Dec 27, 2021
K211770 — R3ACT Stabilization SystemParagon 28, Inc. Dec 25, 2021
K203523 — Fixone hybrid knotless anchorAju Pharm Co., Ltd. Dec 25, 2021
K213136 — CPL Surgical Face MaskControl Print Limited Dec 24, 2021
K202255 — Skypro, SP02 Mask (3)Skypro Medical Supplies Company Dec 24, 2021
K212921 — Nitrile Examination Golves Powder FreeJiangsu Standard Health Co.,Ltd Dec 24, 2021
K213208 — Twist DrillsBiomet Microfixation Dec 23, 2021
K213219 — Vy Spine™ VyWasher™ Buttress SystemVy Spine, LLC Dec 23, 2021
K212088 — Integrity Implants Navigated InstrumentsIntegrity Implants, Inc. Dec 23, 2021
K213766 — dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0TInvivo Corporation Dec 23, 2021
K203714 — NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax PuttyNu Vasive, Incorporated Dec 23, 2021
K213547 — SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE VanillaTtk Healthcare Limited Dec 23, 2021
K213479 — D²RS and D²RS 9090Stephanix Dec 23, 2021
K212436 — NBR Synthetic Nitrile Examination GlovesShandong Langtai International Trade Co., Ltd. Dec 23, 2021
K210976 — Curian CampyMeridian Bioscience, Inc. Dec 23, 2021
K193407 — Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care Dec 23, 2021
K202788 — Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E Orto Dec 23, 2021
K210992 — Altech® Exhalation Valve (Single Limb and Dual Limb)Meditera Tibbi Malzeme San VE Tic AS Dec 23, 2021
K212767 — SleepRight Select-Comfort Dental GuardSplintek, Inc. Dec 22, 2021
K213024 — Oren LED Perioral Light Therapy SystemShenzhen Kaiyan Medical CO , Ltd. Dec 22, 2021
K212310 — EyeBOX (Model EBX-4)Oculogica, Inc. Dec 22, 2021
K203564 — SEFRIA Oxycodone Oral Fluid Enzyme ImmunoassayImmunalysis Corporation Dec 22, 2021
K210711 — Neocis Guidance System (NGS) with Yomi Plan v2.0.1Neocis, Inc. Dec 22, 2021
K212914 — Glovmaster Nitrile Examination Glove Powder FreeGlovmaster Sdn. Bhd. Dec 22, 2021
K213144 — Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White ColorsShen Wei USA, Inc. Dec 22, 2021
K213411 — iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd. Dec 22, 2021
K210147 — Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face ShieldUnicoglobal, Inc. Dec 22, 2021
K213691 — Solas ORCirdan Imaging, Ltd. Dec 22, 2021
K212397 — StealthStation S8 Cranial v2.0Medtronic Navigation Dec 22, 2021
K212603 — Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd. Dec 22, 2021
K213225 — Diode Laser System GP900A8, Diode Laser System GP900Q8Shenzhen Gsd Tech Co., Ltd. Dec 22, 2021
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