510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of , the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years
45,902 of the 176,299 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.
Show the numbers
510(k) clearances by decision year, the last 15 years of ingested records
YearClearances
20123,135
20133,052
20143,202
20153,020
20162,956
20173,200
20183,062
20192,918
20202,923
20213,023
20223,209
20233,346
20243,129
20253,225
20262,502
176,299 records, page 150 of 3526
510(k) clearances, page 150 of 3526
K numberDeviceApplicantProduct codeClassDecision date
K240642SMART Bun-Yo-Matic CTDisior OyQIHClass II
K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AGHRSClass II
K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co., Ltd.GEXClass II
K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)Schoelly Fiberoptic, GmbHGCJClass II
K233162Freedom Peripheral Nerve Stimulator (PNS) SystemCuronix LLCGZFClass II
K233158Copra Smile, Copra Supreme HyperionWhitepeaks Dental Solutions GmbHEIHClass II
K233117Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)Nakanishi Inc.EBWClass I
K232161DeepRhythm PlatformMedicalgorithmics S.A.DPSClass II
K230675VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSpecific DiagnosticsSANClass II
K232997EVIS Exera III Gastrointestinal Videoscope GIF-1TH190Olympus Medical Systems Corp.FDSClass II
K241412Invisalign SystemAlign Technology, Inc.NXCClass II
K240774Pen InjectorWuxi Nest Biotechnology Co., LtdFMFClass II
K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP TechnologyDepuy Ireland UCMBHClass II
K240583IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.OHTClass II
K240552Irrisept Antimicrobial Wound LavageIrriMAX CorporationFROUnclassified
K240196Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)Yuwonmeditech Co., Ltd.GCJClass II
K233867Fitbone TrochantericOrthofix SRLHSBClass II
K233553MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI AdapterThayer Medical CorportationCAFClass II
K233294Automatic Biopsy Needle BAM, Semi-Automatic Needle BIMItp Innovative Tomography Products GmbHKNWClass II
K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.LFLUnclassified
K241428AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupHangzhou AllTest Biotech Co.,LtdNFTClass II
K241416Ion 3DSurgentec LLCMRWUnclassified
K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co.,Ltd.GEXClass II
K240684Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co.,LTDIYNClass II
K233987Veraband™Arbor Medical Innovations, LLCLELClass II
K233331MediOMxPmx, Inc.LLZClass II
K233324Molecular Transport Media - MTMAlb LuzQBDClass II
K233256Robotic Integration InstrumentsDePuy SynthesOLOClass II
K233255CROSSNAV Navigation Enabled InstrumentsDePuy SynthesOLOClass II
K233060Elecsys Folate IIIRoche Diagnostics GmbHCGNClass II
K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLCPNOClass II
K241469iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented MaskSleepNet CorporationBZDClass II
K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.MNWClass II
K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.r.l.GEXClass II
K2412503DMax Light MeshDavol Inc., Subsidiary of C. R. Bard, Inc.FTLClass II
K241083SIS SystemSurgical Information Sciences, Inc.QIHClass II
K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.OLOClass II
K240817VersaWrapAlafair Biosciences, Inc.OWWClass II
K240729Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61)Shenzhen Pango Medical Electronics Co., LtdDXNClass II
K240721ExcelsiusFlex™Globus Medical, Inc.OLOClass II
K240696Airdog X8 Air Purifier (KJ800F-X8)Suzhou Beiang Smart Technology Co., LtdFRFClass II
K240124BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaderVivachek Biotech (Hangzhou) Co., LtdDJGClass II
K240002G-Vitri™ Vitrification StrawGimbo Medical Technology Shenzhen Co., Ltd.MQKClass II
K233991CanGaroo RM Antibacterial EnvelopeElutia Inc.FTMClass II
K233955Clarius OB AIClarius Mobile Health CorpIYNClass II
K233707Hft150Invent Medical CorporationBTTClass II
K233496EndeavorOTCAkili Interactive Labs, Inc.QFTClass II
K233254TELIGEN System Navigation Ready InstrumentsDePuy SynthesOLOClass II
K233238Air Pressure Therapy System (Model:VU-IPC4M)Xiamen Weiyou Intelligent Technology Co.,LtdIRPClass II
K233228Spine Navigation and Robotic-Assistance DeviceEcential RoboticsOLOClass II