510(k) Clearances in 2021 — Page 48

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 48 of 61)
510(k) clearancesDetails
K203685 — Disposable Surgical Face MaskXiantao Zhongyi Safety & Protection Products Co., Ltd. Mar 26, 2021
K203788 — DermaV Laser SystemLutronic Corporation Mar 26, 2021
K201426 — MyCRO BandOtto Bock Healthcare LP Mar 26, 2021
K203038 — Toro-L Interbody Fusion SystemIntegrity Implants, Inc. Mar 26, 2021
K210207 — Humeral Eccentric Reverse MetaphysisMedacta International S.A. Mar 26, 2021
K201957 — A8, A9 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Mar 26, 2021
K210205 — DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating SystemSynthes (USA) Products, LLC Mar 26, 2021
K201466 — Tranberg CLS Laser ApplicatorClinical Laserthermia Systems, AB Mar 26, 2021
DEN200019 — Oxehealth Vital SignsOxehealth Limited Mar 26, 2021
K201197 — TruAbutment DS, TruBase STruabutment, Inc. Mar 26, 2021
K210638 — i-ED COIL SystemKaneka Medical America, LLC Mar 26, 2021
K203259 — FairFix Adjustable Button SystemMedacta International S.A. Mar 26, 2021
K201634 — RG 3ml Medication CartridgeChengdu Shifeng Medical Technology Co., Ltd. Mar 26, 2021
K202725 — ETD4000Therasigma, LLC Mar 26, 2021
K202073 — NeedleSmart Professional (NS Pro)Needlesmart Limited Mar 25, 2021
K210667 — FIREBIRD SI Fusion SystemOrthofix, Inc. Mar 25, 2021
K203834 — Arthrex Patella SuturePlatesArthrex, Inc. Mar 25, 2021
K203273 — FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens Mar 25, 2021
K210566 — LEGION Porous CR Narrow Femoral ComponentsSmith & Nephew, Inc. Mar 25, 2021
K202944 — NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemNorthgate Technologies, Inc. Mar 25, 2021
K210333 — DiaPasteDiaDent Group International Mar 25, 2021
K202824 — BRS Procedure Face MaskBlackbriar Regulatory Services, LLC Mar 25, 2021
K200177 — Low-frequency Multi-function physiotherapy instrumentShenzhen Kentro Medical Electronics Co., Ltd. Mar 25, 2021
K201878 — ST-Z5Z-Systems AG Mar 25, 2021
K201376 — ANAM Test SystemVista Lifesciences, Inc. Mar 25, 2021
K202083 — Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy DrugsShen Wei USA, Inc. Mar 25, 2021
K202133 — Disposable Medical MaskHangzhou Qianzhiya Sanitary Products Co., Ltd. Mar 25, 2021
K201982 — Air compression therapy system FO-3001; Air compression therapy system FO-3008Foshan Hongfeng Co., Ltd. Mar 25, 2021
K203776 — Surgical Masks, Model SNN200640 & MN112Sq Medical Supplies, Inc. Mar 25, 2021
K203547 — Nalu Neurostimulation SystemBoston Scientific Neuromodulation Mar 25, 2021
K203133 — ENvizion Medical ENvue ENvizion Medical Enteral Feeding TubeEnvizion Medical , Ltd. Mar 24, 2021
K210498 — Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd. Mar 24, 2021
K202650 — Medical disposable face mask non sterileGuangdong Zhong Ling Industrial Group Co., Ltd. Mar 24, 2021
K202015 — White ENDOSEAL MTAMaruchi Mar 24, 2021
K202080 — Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black ColorShen Wei USA, Inc. Mar 24, 2021
K203560 — STERIZONE VP4 Test PackTso3 Inc., Now A Part Of Stryker Mar 24, 2021
K203703 — I-Q ViewFirst Source, Inc. Mar 24, 2021
K201626 — Safety Subcutaneous Infusion SetEpic Medical Pte. , Ltd. Mar 24, 2021
K203225 — Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging SystemCanon Medical Systems Corporation Mar 24, 2021
K202453 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardSafecare Biotech (Hangzhou) Co., Ltd. Mar 24, 2021
K202483 — MyHomeDocMyhomedoc , Ltd. Mar 23, 2021
K203064 — ICU Health Surgical MaskPlastikon Industries Mar 23, 2021
K202186 — TrueRelief DeviceTruerelief Mar 23, 2021
K210325 — APOLLO Anterior Cervical Plate (ACP) SystemAurora Spine, Inc. Mar 23, 2021
K210828 — DIOnavi-Denture02Dio Corporation Mar 23, 2021
K203592 — Tigertriever and Tigertriever 17 Revascularization DevceRapid Medical Ltd. Mar 23, 2021
K203780 — Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc. Mar 23, 2021
K202917 — LigaSure Exact Dissector, Nano-coatedCovidien, LLC Mar 23, 2021
K203391 — TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. Mar 23, 2021
K203205 — Navigated Spine InstrumentsStryker Spine Mar 23, 2021
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