510(k) Clearances in 2021 — Page 55

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 55 of 61)
510(k) clearancesDetails
K203426 — Surgical Face Mask (non-sterile)Nantong Taiweishi Medical Technology Co., Ltd. Feb 18, 2021
K201408 — Demetra Analytics ToolkitBarco N.V. Feb 18, 2021
K210132 — s-Clean SQ-SL Implant System RegularDentis Co., Ltd. Feb 17, 2021
K202338 — SpaceFlex ShoulderG21, S.R.L. Feb 17, 2021
K210252 — iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement SystemConformis, Inc. Feb 17, 2021
K203307 — VIOLAVascular Graft Solutions, Ltd. Feb 17, 2021
K203399 — FITBONE(R) TAAWittenstein Intens GmbH Feb 17, 2021
K202401 — Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable ProteinEco Medi Glove Sdn. Bhd. Feb 17, 2021
K201391 — Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc. Feb 16, 2021
K210444 — EZ-Injec LDV Sterile Safety NeedlePoonglim Pharmatech, Inc. Feb 16, 2021
K203419 — RelivionNeurolief , Ltd. Feb 16, 2021
K203312 — Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation Feb 16, 2021
K210443 — PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc. Feb 16, 2021
K200626 — VesselIQ XpressGE Medical Systems SCS Feb 16, 2021
K201732 — Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie OnDukal Corporation Feb 16, 2021
K210114 — Rebar Micro CatheterMicro Therapeuatics, Inc. D/B/A Ev3 Neurovascular Feb 16, 2021
K210035 — ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate SystemAegis Spine Feb 16, 2021
K210234 — cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. Feb 16, 2021
K203670 — Extra Large Check-Flo IntroducerCook Incorporated Feb 16, 2021
K200160 — 740 SafeSATZoe Medical, Inc. Feb 15, 2021
K203740 — JuggerKnot Soft AnchorRiverpoint Medical Feb 12, 2021
K202651 — NOA Sleep Apnea and Snoring DeviceOrthoapnea S.L. Feb 12, 2021
K202341 — Disposable Surgical MaskShanghai Jianzhong Medical Packaging Co., Ltd. Feb 12, 2021
K203091 — MucoLock Oral GelPcca, Inc. Feb 12, 2021
K200551 — MectaLIF Transforaminal TiPEEKMedacta Inernational SA Feb 12, 2021
K203191 — LYDUS Nitrile Examination Gloves, Powder FreeNathan Trading Co., Ltd. Feb 12, 2021
K203546 — gammaCore SapphireElectrocore, Inc. Feb 12, 2021
K192742 — Straumann Variobase CInstitut Straumann AG Feb 12, 2021
K203766 — 4D Integrated Treatment ConsoleVarian Medical Systems, Inc. Feb 12, 2021
K203355 — Straumann TLX Novaloc and Cementable AbutmentsInstitut Straumann AG Feb 12, 2021
K201545 — Surgical Face MaskAmphastar Nanjing Pharmaceuticals, Inc. Feb 12, 2021
K202281 — EDS Bioceramic Sealer (Bioseal)Essential Dental Systems Feb 12, 2021
K202611 — Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. Feb 12, 2021
K202368 — Infrared ThermometerShandong Bittel Intelligent Technology Co., Ltd. Feb 12, 2021
K203702 — Vinyl Examination Gloves (Yellow)Xinying Trading Co., Ltd. Feb 12, 2021
K201628 — Panda iRes Warmer, Giraffe WarmerGE Healthcare Feb 12, 2021
K201356 — Plastic LOR SyringeJiangsu Caina Medical Co.,Ltd Feb 12, 2021
K201490 — Electro Flo 6 Airway Clearance SystemMed Systems, Inc. Feb 12, 2021
K201799 — CleaniCalMaruchi Feb 12, 2021
K193280 — MedCAD® AccuPlate® Patient-Specific PlateMedcad Feb 12, 2021
K201292 — TRAUS SIP20Saeshin Precision Co., Ltd. Feb 11, 2021
K203385 — TenoTac Soft Tissue Fixation SystemParagon 28, Inc. Feb 11, 2021
K193662 — Ezlymph, Ezlymph MEezcare Medical Corp Feb 11, 2021
K192839 — DSP Implant SystemD.S.P Industrial Eireli Feb 11, 2021
K210089 — CATSmart, Automated Blood Processing Autotransfusion SystemFresenius Kabi AG Feb 11, 2021
K201222 — Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A Feb 11, 2021
K202219 — VORTRAN GO2VENT with PEEP ValveVortran Medical Technology 1, Inc. Feb 11, 2021
K203557 — EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P. Feb 10, 2021
K203632 — da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable InstrumentsIntuitive Surgical, Inc. Feb 10, 2021
K201454 — DSG Connect TechnologySpineguard S.A. Feb 10, 2021
← Previous Page 55 of 61 Next →