510(k) Clearances in 2023 — Page 54

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 54 of 67)
510(k) clearancesDetails
K230206 — Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc. Mar 24, 2023
K230382 — 3 Series NeoLuxDaavlin Distributing Co. Mar 24, 2023
K222591 — BD BACTEC™ Plus Aerobic/F Culture VialsBecton, Dickinson And Company Mar 24, 2023
K220212 — BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached HolderBecton, Dickinson And Company Mar 24, 2023
K221589 — Starly padShenzhen Xingyuanli Technology Co., Ltd. Mar 24, 2023
K223323 — Blood Collection Needle (with/without Needle Holder)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Mar 24, 2023
K230474 — EVA5 InsufflatorPalliare , Ltd. Mar 24, 2023
K223076 — BD Texium™ Closed Male LuerCare Fusion Mar 24, 2023
K230002 — Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy DrugsMah Sing Healthcare Sdn. Bhd. Mar 24, 2023
K223895 — Disposable Medical Nitrile Examination GlovesHebei Titans Hongsen Medical Technology Co., Ltd. Mar 23, 2023
K222367 — SAVE GBRDentis Co., Ltd. Mar 23, 2023
K223765 — ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc. Mar 23, 2023
K223441 — SpaceFlex Acetabular CupG21, S.R.L. Mar 23, 2023
K223488 — ClosureFast™ Endovenous Radiofrequency Ablation CatheterMedtronic, Inc. Mar 23, 2023
K222332 — MeMed BVMeMed Diagnostics, Ltd. Mar 23, 2023
K221585 — 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit3M Healthcare Business Group Mar 23, 2023
K222096 — Endo Ultrasonic ActivatorFoshan Coxo Medical Instrument Co., Ltd. Mar 23, 2023
K222105 — RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp. Mar 23, 2023
K223419 — Triever16 CurveInari Medical Mar 23, 2023
K222620 — Sterilized Latex Surgical GlovesSuzhou Colour-Way New Material Co., Ltd. Mar 23, 2023
K221805 — AccurSound Electronic Stethoscope AS-101Heroic Faith International , Ltd. Mar 23, 2023
K222423 — Fixone All Suture AnchorAju Pharm Co., Ltd. Mar 23, 2023
K230482 — Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc. Mar 23, 2023
K212207 — Sterile Hypodermic Syringe for Single UseShandong Weigao Group Medical Polymer Co., Ltd. Mar 23, 2023
K222151 — Sterilization WrapKenpax International Limited Mar 23, 2023
K222859 — 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG)3M Mar 23, 2023
K212121 — VHT-200 Wound Treatment SystemVaporox, Inc. Mar 23, 2023
K212394 — Implant-One Multi-Unit AbutmentImplant Logistics, Inc. Mar 23, 2023
K223049 — CardioSTAT® ECG Test SolutionIcentia, Inc. Mar 22, 2023
K223837 — SPIRA®-C Integrated Fixation SystemCamber Spine Technologies Mar 22, 2023
K230191 — Arise™ UHP Dilatation CatheterCreagh Medical, Ltd. Mar 22, 2023
K223593 — Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical TrocarTaiwan Surgical Corporation Mar 22, 2023
K223889 — Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited Mar 22, 2023
K230583 — Tryptik TiSpineart SA Mar 22, 2023
K230533 — Motive™ ElectrodeCymedica Orthopedics, Inc. Mar 22, 2023
K221402 — CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc. Mar 22, 2023
K223086 — Ceribell Instant EEG HeadcapCeribell, Inc. Mar 22, 2023
K223824 — POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure SensorBoston Scientific Corporation Mar 22, 2023
K230142 — Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc. Mar 22, 2023
K213362 — BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens PanelBiofire Defense, LLC Mar 22, 2023
K222036 — MPXA-2000Medipixel, Inc. Mar 22, 2023
K220464 — Tigon Medical Gryphon Anchor LineTigon Medical Mar 22, 2023
K230194 — HF Surgery Generator 400KHZRichard Wolf Medical Instruments Corporation Mar 22, 2023
K223844 — Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)Thermo Fisher Scientific Mar 21, 2023
K223708 — Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC Mar 21, 2023
K222617 — EasyTouch Lancing DeviceStat Medical Devices Mar 21, 2023
K223672 — Instrument Case P1340904Cochlear Mar 21, 2023
K230471 — LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG Mar 21, 2023
K230520 — Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)Barco N.V. Mar 21, 2023
K230054 — DSM Biomedical Calcium Phosphate CementDsm Biomedical Mar 21, 2023
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