510(k) Clearances in 2022 — Page 37

3,209 510(k) clearances total

Browse FDA 510(k) clearances granted in 2022. RegDataLab tracks 3,209 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2022 (page 37 of 65)
510(k) clearancesDetails
K212325 — EEG-acpSomnomedics GmbH Jun 15, 2022
K221500 — ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Jun 14, 2022
K221386 — PERF-GEN Pulsatile Perfusion SolutionInstitut Georges Lopez Jun 14, 2022
K221620 — Digital Radiography CXDI-Elite, Digital Radiography E1Canon, Inc. Jun 14, 2022
K212808 — Logic Hd camera head green, System greenRichard Wolf Medical Instruments Corporation Jun 14, 2022
K213467 — EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) Jun 14, 2022
K220550 — Disposable Surgical Face Mask (M663BE, M663BT)Makrite Industries, Inc. Jun 14, 2022
K221387 — BEL-GEN Cold Storage SolutionInstitut Georges Lopez Jun 14, 2022
K211466 — Yomi Robotic System with YomiPlan GoNeocis, Inc. Jun 14, 2022
K220004 — Zsquare ENT-Flex EndoscopeZsquare, Ltd. Jun 14, 2022
K221695 — 3M Filtek Supreme Flowable Restorative3M Company Espe Dental Products Jun 13, 2022
DEN220006 — ProdiGICovidien, LLC Jun 13, 2022
K220157 — Disposable Hemostatic Closure Clip DeviceMicro-Tech (Nanjing) Co., Ltd. Jun 13, 2022
K221081 — iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray SystemFirst Source, Inc. Jun 13, 2022
K203208 — Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. Jun 12, 2022
K221384 — Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2Hivox Biotek, Inc. Jun 11, 2022
K221065 — MediLabSigma Scientific Services, LLC Jun 10, 2022
K213667 — iFuse-TORQ® Implant SystemSI-BONE, Inc. Jun 10, 2022
K213442 — Extroducer Infusion Catheter SystemSmartWise Sweden AB Jun 10, 2022
K221658 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters For Disease Control And Prevention Jun 10, 2022
K220319 — Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH Jun 10, 2022
K213097 — Armory MotionPain Management Technologies, Inc. Jun 10, 2022
K220528 — Surgical Isolation Cover GownWuhan Dymex Healthcare Co., Ltd. Jun 10, 2022
K221362 — Omni Foot and Ankle Plating SystemExremity Medical, LLC Jun 10, 2022
K213519 — Rune Labs Tremor Transducer SystemRune Labs, Inc. Jun 10, 2022
K220894 — SmileGuardEnvisiontec GmbH Jun 10, 2022
K221087 — Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4Medtronic Navigation, Inc. Jun 10, 2022
K210582 — EasyClip® and EasyClip® XpressStryker GmbH Jun 10, 2022
K213515 — WesperO2Wesper, Inc. Jun 10, 2022
K220420 — Saffron Fixation SystemColoplast A/S Jun 10, 2022
K203757 — Elecsys AMHRoche Diagnostics Jun 10, 2022
K221376 — Nalu Neurostimulation SystemBoston Scientific Neuromodulation Jun 10, 2022
K220796 — IntellaMap Orion High Resolution Mapping CatheterBoston Scientific Corporation Jun 10, 2022
K212024 — PAL SystemMicroaire Surgical Instruments, LLC Jun 10, 2022
K221393 — Swoop Portable MR Imaging SystemHyperfine, Inc. Jun 10, 2022
K220717 — RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC Jun 9, 2022
K221077 — Auryon Atherectomy SystemEximo Medical, Ltd. Jun 9, 2022
K212663 — HELIOS IV 785Laseroptek Co., Ltd. Jun 9, 2022
K211981 — KHEIRON® Spinal Fixation SystemS.M.A.I.O Jun 9, 2022
K211000 — ACUTRONIlooda Co,., Ltd. Jun 9, 2022
K211909 — Cysto-Gastro-SetsG-Flex Europe Sprl Jun 9, 2022
K220988 — EksoNREkso Bionics, Inc. Jun 9, 2022
K220259 — ALLY Adaptive Cataract Treatment SystemLensar, Inc. Jun 9, 2022
K213258 — Nasogastric Feeding Tubes - ENFit Port - PVCCair Lgl Jun 9, 2022
K221339 — Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionContego Medical, Inc. Jun 9, 2022
K220729 — The Luminance RED Acne DeviceLuminance Medical Ventures, Inc. Jun 9, 2022
K221071 — Niti-S Biliary Slim M StentTaewoong Medical Co., Ltd. Jun 9, 2022
K220782 — IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody SystemAlphatec Spine, Inc. Jun 9, 2022
K221368 — Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd. Jun 9, 2022
K213587 — MyCRO BandOtto Bock Healthcare LP Jun 9, 2022
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