510(k) Clearances in 2021 — Page 2

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 2 of 61)
510(k) clearancesDetails
K211022 — Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.Central Medicare Sdn Bhd Dec 22, 2021
K211691 — Ultrast GelUltrast, Inc. Dec 22, 2021
K213428 — EdgeProBiolase, Inc. Dec 22, 2021
K212285 — Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)Oriental Inspiration Limited Dec 22, 2021
K213159 — Encore SystemSiesta Medical, Inc. Dec 22, 2021
K213207 — Sheath, Stopcock AccessoryOlympus Winter & Ibe GmbH Dec 22, 2021
K213094 — ID-500 iRestore Hair Growth SystemFreedom Laser Therapy, Inc. Dec 22, 2021
K202404 — BoneMRIMriguidance B.V. Dec 22, 2021
K210305 — Pulse OximeterDongguan Lingxin Technologies Co., Ltd. Dec 22, 2021
K210978 — BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer NeedleBecton, Dickinson And Company Dec 22, 2021
K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation Dec 22, 2021
K213140 — Claritas iPETClaritas Healthtech Pte, Ltd. Dec 22, 2021
K210099 — Meticuly Patient-Specific Titanium Mesh ImplantMeticuly Co., Ltd. Dec 21, 2021
K212770 — VisionSoftsmile, Inc. Dec 21, 2021
K213596 — OSSIOfiber Compression Screw, 3.5mmOSSIO , Ltd. Dec 21, 2021
K213705 — DRSplusCentervue S.P.A. Dec 21, 2021
K212613 — Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)Koon Seng Sdn Bhd Dec 21, 2021
K211109 — N1 TiUltra TCC Implant SystemNobel Biocare Services AG Dec 21, 2021
K212266 — FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation Dec 21, 2021
K213006 — Vinyl Examination GlovesTaian Hengchang Medical Technology Co., Ltd. Dec 21, 2021
K213129 — Restoration Modular 115mm Conical Distal StemHowmedica Osteonics Corp., Dba Stryker Orthopaedics Dec 21, 2021
K212690 — qXR-BTQure.Ai Technologies Dec 21, 2021
K213045 — TearCare SystemSight Sciences, Inc. Dec 21, 2021
K213456 — Xenco Medical Multilevel CerviKitXenco Medical, LLC Dec 21, 2021
K213301 — InCore Subtalar SystemNextremity Solutions, Inc. Dec 21, 2021
K211086 — The Progen™ Trochanteric Nail SystemOrtho Development Corporation Dec 21, 2021
K203660 — TRI-matrix Implant LineTri Dental Implants Int. AG Dec 21, 2021
K212155 — TheraFace LEDTheragun, Inc. Dec 21, 2021
K212730 — BellaTek Encode Emergence Healing AbutmentsBiomet 3I, LLC Dec 21, 2021
K210670 — BU-CADTaihao Medical, Inc. Dec 21, 2021
DEN210024 — CavaClear Laser SheathSpectranetics, Inc. Dec 21, 2021
K211078 — Progreat LambdaTerumo Clinical Supply Co., Ltd. Dec 21, 2021
K210331 — CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc. Dec 21, 2021
K213139 — SURGmatic S15 L ProKavo Dental GmbH Dec 21, 2021
K212830 — CT3000ProSrs Medical Dec 21, 2021
K211918 — iCOquit® Smokerlyzer®Bedfont Scientific, Ltd. Dec 21, 2021
K210968 — reVive Light Therapy EssentialsLed Technologies, Inc. Dec 21, 2021
K203343 — Wesper LabWesper, Inc. Dec 21, 2021
K212859 — First ReliefDyansys, Inc. Dec 20, 2021
K212776 — Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC Dec 20, 2021
K203741 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/mlThermo Fisher Scientific Dec 20, 2021
K211521 — 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)3M Healthcare Business Group Dec 20, 2021
K211750 — Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)National Bridge Industrial (S.Z.) Co., Ltd. Dec 20, 2021
K213031 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP ConsoleZoll Circulation, Inc. Dec 20, 2021
K211185 — IPL Home Use Hair Removal DeviceShenzhen Beauty Every Moment Intelligent Electric Co., Ltd. Dec 20, 2021
K211842 — Servator M SALF SolutionS.A.L.F. Spa Dec 20, 2021
K212492 — Frax 1940 for Nordlys and Frax ProCandela Corporation Dec 20, 2021
K211847 — AdVance XP Male Sling SystemBoston Scientific Corporation Dec 20, 2021
K211865 — Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)Liao Ning Shangwei Medical Products Co., Ltd. Dec 20, 2021
K203468 — TCAT TKA Instrument TrayTHINK Surgical, Inc. Dec 20, 2021
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