510(k) Clearances in 2021 — Page 41

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 41 of 61)
510(k) clearancesDetails
K203311 — ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC May 10, 2021
K210168 — Diode Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd. May 10, 2021
K201504 — Single-use medical poly (vinyl chloride) examination gloveAnhui Bytech Medical Supplies Co., Ltd. May 10, 2021
K203847 — Reprocessed Tri Pulse Compression GarmentRenu Medical, Inc. May 7, 2021
K210366 — Blue Nitrile Powder Free Patient Examination Glove, Non SterileOnetexx Sdn Bhd May 7, 2021
K202145 — Bigfoot Unity Diabetes Management SystemBigfoot Biomedical, Inc. May 7, 2021
K203572 — Karl Storz Radel Sterilization TraysKarl Storz Endoscopy America, Inc. May 7, 2021
K203832 — FuseForce™ Flex Dynamic Compression SystemWright Medical May 7, 2021
K203036 — Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)Central Medicare Sdn Bhd May 7, 2021
K210218 — SURGICAL MASK, Model Name:C015Qingdao Hainuo Biological Engineering Co., Ltd. May 7, 2021
K210755 — Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)Meditech Gloves Sdn Bhd May 7, 2021
K210066 — ImagePilotKonica Minolta, Inc. May 6, 2021
K202031 — Talent-Pro Electromagnetic StimulatorRemed Co., Ltd. May 6, 2021
K201697 — Umbilical Vessels CatheterHaolang Medical USA Corporation May 6, 2021
K210705 — Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3Defender Safety, Inc. May 6, 2021
K211034 — Corvus Radiation Therapy Planning SystemBest Nomos May 6, 2021
K202578 — KardiFlex NC Coronary Dilatation CatheterMedcaptain Life Science Co., Ltd. May 6, 2021
K202971 — DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company May 6, 2021
K203640 — CoolSeal RevealBolder Surgical, LLC May 6, 2021
K203183 — CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)Bolder Surgical, LLC May 6, 2021
K210728 — CONDUIT InstrumentsMedos International SARL May 6, 2021
K202598 — 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 33A Medical Products Co., Ltd. May 6, 2021
K201936 — SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLGilero, LLC May 6, 2021
K210191 — Identity Imprint Knee Replacement SystemConformis, Inc. May 6, 2021
K210353 — AutoCap RXBoston Scientific Corporation May 6, 2021
K210529 — Dr. Yglo Wart RemoverTheotclab Healthcare B.V. May 6, 2021
K211112 — OIC External Fixation SystemOrthopaedic Implant Company May 5, 2021
K200765 — Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd. May 5, 2021
K203525 — D functionIto Co., Ltd. May 5, 2021
K210451 — OrthoGold 100Tissue Regeneration Technologies, LLC May 5, 2021
K211008 — Bose SoundControl Hearing AidsBose Corporation May 5, 2021
K210298 — GR-14 Resin SystemPro3Dure Medical GmbH May 5, 2021
K203698 — CoLink Sfx Implant SystemIn2Bones USA, LLC May 4, 2021
K210682 — SOTA Cloud ImagingSota Precision Optics, Inc. Dba Sota Imaging May 4, 2021
K200893 — ProntoPump Sterile Tube SetIpax, Inc. May 4, 2021
K202521 — PtoleMedic SystemLento Medical Innovation, Inc. May 4, 2021
K201152 — Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. May 4, 2021
K200768 — Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG May 4, 2021
K210669 — Quantum Mini Ventilation ModuleSpectrum Medical , Ltd. May 4, 2021
K210304 — Surgical MaskJin Pin Electrical Co., Ltd. Zhuhai S.E.Z. May 4, 2021
K203529 — VASSALLO GT HybridFilmecc Co., Ltd. May 4, 2021
K203192 — NaviCam Xpress Stomach SystemAnx Robotica Corp May 4, 2021
K203218 — CaP Spheres Pellet PackZimmer Biomet Spine, Inc. May 4, 2021
K201671 — A-Link ZAcuity Surgical Devices, LLC May 4, 2021
K202921 — Uro-G CystoscopeUroviu Corporation May 4, 2021
K203655 — Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)Innovative Health, LLC May 4, 2021
K203450 — EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)Capnostics, LLC May 4, 2021
K203135 — Medline Vacu-line Suction AspiratorMedline Industries, Inc. May 4, 2021
K203710 — Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG May 3, 2021
K203409 — MC3 Crescent Jugular Dual Lumen CatheterMc3, Inc. May 3, 2021
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