510(k) Clearances — Page 182

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 182 of 3,525)
ClearancesDetails
K232220 — SS Abutment SystemOsstem Implant Co., Ltd. Dec 5, 2023
K230734 — Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)Precision Healing, LLC Dec 5, 2023
K231005 — Aurelia Surgical Mask ASTM Level 1; Aurelia Surgical Mask ASTM Level 2Supermax Healthcare Canada-Supermax Medical Dec 5, 2023
K233490 — SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC Dec 5, 2023
K231230 — Optina-4C (MHRC-C1N)Optina Diagnostics, Inc. Dec 5, 2023
K223170 — Electronic Blood Pressure Monitor, model: HTD6602USHetaida Technology Co., Ltd. Dec 5, 2023
K233568 — Ceevra Reveal 3+Ceevra, Inc. Dec 5, 2023
K231923 — Liberty SI Lateral Implant SystemSpinal Simplicity, LLC Dec 5, 2023
K232440 — Adravision PerioAdra Corporation Dec 5, 2023
K233335 — Tablo® Hemodialysis SystemOutset Medical, Inc. Dec 5, 2023
K232308 — Monarch Blood Collection SetThe Monarch Company Dec 4, 2023
K223783 — cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. Dec 4, 2023
K232693 — Tyber Medical Distal Radius Plating SystemTyber Medical, LLC Dec 4, 2023
K220525 — RESPONDER Polysaccharide HemostatStarch Medical, Inc. Dec 4, 2023
K233347 — Verruca-Freeze® HCryosurgery, Inc. Dec 4, 2023
K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesNovastep Dec 4, 2023
K230648 — Access hsTnIBeckman Coulter, Inc. Dec 4, 2023
K232581 — Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd. Dec 4, 2023
DEN230045 — SonuSound Health Systems, Inc. Dec 4, 2023
K231895 — Maxtec MaxBlend2+pMaxtec, LLC Dec 4, 2023
K232932 — Intense Pulse Light Therapeutic ApparatusShenzhen Greatro Electronic Technology Co., Ltd. Dec 4, 2023
K233397 — Cosine-10TM Diagnostic CatheterMedtronic, Inc. Dec 2, 2023
K231476 — TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring SystemSinocare, Inc. Dec 1, 2023
K232249 — PENTAX Medical Gas/Water Feeding Valve OE-B14Pentax Of America, Inc. Dec 1, 2023
K233529 — BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free ConnectorBecton Dickinson Infusion Therapy Systems, Inc. Dec 1, 2023
K230528 — Extension SetMedcaptain Life Science Co., Ltd. Dec 1, 2023
K230391 — BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson And Company Dec 1, 2023
K233159 — pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504Fresenius Medical Care Renal Therapies Group, LLC Dec 1, 2023
K231057 — Antibacterial Gel Wound DressingWinner Medical Co., Ltd. Dec 1, 2023
K233149 — CATHTONG III Tapered PICC CatheterL&Z Us, Inc. Dec 1, 2023
K233301 — ULTRApulse Alpha CO2 Laser System, Delivery Devices and AccessoriesLumenis Be, Ltd. Dec 1, 2023
K232758 — Comatryx OTCStrukmyer Medical, LLC Dec 1, 2023
K231179 — Slinky CatheterAnoxia Medical, Inc. Dec 1, 2023
K232093 — Woo More Play Coconut Love OilWoo Essentials, Inc. Dec 1, 2023
K231817 — AlignerFlow LCVoco GmbH Dec 1, 2023
K232418 — Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd. Dec 1, 2023
K232438 — Dental Glass Ceramics BlocksAibodent Biotechnology Co., Ltd. Dec 1, 2023
K230988 — Vial2Bag Advanced® 13mm Admixture DeviceWest Pharma. Services IL, Ltd. Dec 1, 2023
K232856 — Syngo Carbon ClinicalsSiemens Healthcare GmbH Dec 1, 2023
K230621 — LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic ProbesSurgical Principals, Inc. Dec 1, 2023
K230639 — Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC Dec 1, 2023
K232708 — Intense pulsed light therapy deviceHebei Zhemai Technology Co., Ltd. Dec 1, 2023
K231272 — OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation NailOSSIO , Ltd. Dec 1, 2023
K231211 — Medline ComfortTemp Patient Warming SystemMedline Industries, LP Dec 1, 2023
K232262 — LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )Surgease Innovations Limited Nov 30, 2023
K232611 — TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc. Nov 30, 2023
K230669 — L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline CathetersArgon Medical Devices Nov 30, 2023
K230061 — Insulin SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Nov 30, 2023
K232716 — Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd. Nov 30, 2023
K232709 — Diode laser therapy deviceHebei Zhemai Technology Co., Ltd. Nov 30, 2023
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