FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
3289–3312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 2025
GPS Advanced
K251648 · FMF
Prosidyan, Inc.
Orthopedic · 26d
Cleared Jun 24, 2025
ProAM ALIF System
K251644 · OVD
Pro Surgical, Inc.
Orthopedic · 26d
Cleared Jun 24, 2025
PediFlex™ Flexible Nail System
K251362 · HTY
OrthoPediatrics Corp.
Orthopedic · 54d
Cleared Jun 24, 2025
Bridge Plus Occlusion Balloon (590-002)
K251358 · MJN
Philips Image Guided Therapy Devices
Cardiovascular · 55d
Cleared Jun 24, 2025
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors...
K250326 · KFM
Spectrum Medical S.R.L.
Cardiovascular · 139d
Cleared Jun 24, 2025
HyperSnap Surgical System (HSS)
K250268 · SFE
Hypervision Surgical
General & Plastic Surgery · 145d
Cleared Jun 24, 2025
MIST IC
K243009 · NHA
Imagine Milling Technologies, LLC
Dental · 271d
Cleared Jun 23, 2025
Hippocampe Marathon and Trail
K251570 · IQC
Vipamat Sarl
Physical Medicine · 32d
Cleared Jun 23, 2025
TempFIT Temporary Crown and Bridge Resin
K251271 · EBG
Rizhao Huge Biomaterials Company, Ltd.
Dental · 60d
Cleared Jun 23, 2025
Ceftobiprole BPR 5 µg Disc
K250885 · JTN
Liofilchem, Inc.
Microbiology · 90d
Cleared Jun 23, 2025
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190)
K250862 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 94d
Cleared Jun 23, 2025
Ear Thermometer (EAR-E101)
K250470 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 125d
Cleared Jun 23, 2025
Digital Prism Correction Feature (DPCF)
K250143 · SCW
Apple, Inc.
Ophthalmic · 157d
Cleared Jun 23, 2025
WiTOF
K243339 · KOI
Idmed
Anesthesiology · 241d
Cleared Jun 23, 2025
Cranial 4Pi Immobilization
K243142 · IYE
Brainlab AG
Radiology · 266d
Cleared Jun 23, 2025
OPXION Optical Skin Viewer (OPXSV1-01F)
K242924 · NQQ
Opxion Technology, Inc.
General & Plastic Surgery · 272d
Cleared Jun 20, 2025
NovoSorb BTM
K251567 · QSZ
Polynovo Biomaterials Pty, Ltd.
General & Plastic Surgery · 29d
Cleared Jun 20, 2025
FUBUKI XF-R Neurovascular Long Sheath
K251560 · QJP
Asahi Intecc Co., Ltd.
Neurology · 30d
Cleared Jun 20, 2025
MC2™ Two-Stage Venous Cannula
K251258 · DWF
Medtronic, Inc.
Cardiovascular · 58d
Cleared Jun 20, 2025
ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02)
K251248 · ITI
Jinhua Qidian Vehicle Co., Ltd.
Physical Medicine · 58d
Cleared Jun 20, 2025
Branchor X Balloon Guide Catheter
K251240 · QJP
Asahi Intecc Co., Ltd.
Neurology · 59d
Cleared Jun 20, 2025
Restrata Soft Tissue Reinforcement (STR)
K251224 · OXF
Acera Surgical, Inc.
General & Plastic Surgery · 60d
Cleared Jun 20, 2025
FloPatch FP120
K251114 · DPW
Flosonics Medical
Cardiovascular · 70d
Cleared Jun 20, 2025
PathPresenter Clinical Viewer
K250968 · QKQ
Pathpresenter Corporation
Pathology · 81d