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

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174,955 results
121–144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 2026
Portable Oxygen Concentrator
K252399 · CAW
Honsun (Nantong) Co., Ltd.
Anesthesiology · 321d
Cleared Jun 16, 2026
NEUROMARK System (NMK00301)
K261833 · GEI
Neurent Medical , Ltd.
Ear, Nose, Throat · 14d
Cleared Jun 16, 2026
Augment Off-Axis Instrument System
K261683 · PHX
Zimmer, Inc.
Orthopedic · 26d
Cleared Jun 16, 2026
I.T.S. Clavicle Plates with Angular Stability
K260958 · HRS
I.T.S. GmbH
Orthopedic · 85d
Cleared Jun 16, 2026
Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156,...
K260899 · OAP
Zdeer Technology (Henan) Co., Ltd.
General & Plastic Surgery · 90d
Cleared Jun 16, 2026
ACUSON Sequoia Diagnostic Ultrasound System
K260844 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 92d
Cleared Jun 16, 2026
Z1 Hip System
K260831 · LZO
Zimmer, Inc.
Orthopedic · 95d
Cleared Jun 16, 2026
VicorderCS (VCS-SYS-1100)
K260693 · DXN
80 Beats Medical GmbH
Cardiovascular · 105d
Cleared Jun 16, 2026
TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
K260425 · NUH
Hivox Biotek, Inc.
Neurology · 126d
Cleared Jun 16, 2026
LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)
K254025 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 182d
Cleared Jun 16, 2026
BOSS
K253723 · NPM
Medpark Co., Ltd.
Dental · 204d
Cleared Jun 16, 2026
LimiFlex® Dynamic Sagittal Tether Instrument Set
K253374 · SGL
Empirical Spine
Orthopedic · 259d
Cleared Jun 16, 2026
myAblation Guide (VC10A)
K253264 · QTZ
Siemens Healthcare GmbH
Radiology · 260d
Cleared Jun 16, 2026
Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352,...
K253231 · OAP
Hubei Yjt Technology Co.,Ltd
General & Plastic Surgery · 260d
Cleared Jun 16, 2026
Prophecy Incompass Surgical Planning System
K253159 · HSN
Wright Medical Technology, Inc....
Orthopedic · 263d
Cleared Jun 16, 2026
FUJIFILM Endoscope Model EB-840S
K253137 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 264d
Cleared Jun 16, 2026
Lipoprotein (a) Molarity Assay
K253069 · DFC
Diazyme Laboratories, Inc.
Chemistry · 266d
Cleared Jun 16, 2026
HERA Interlocking Intramedullary Nailing System
K253046 · HSB
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 267d
Cleared Jun 16, 2026
KT Airway Clearance Device II (KT-3)
K253001 · NHJ
Hunan Ruijiong Biotech Co., Ltd.
Anesthesiology · 270d
Cleared Jun 15, 2026
Permatage XT Settable Bone Putty
K261265 · GXP
Orthocon, Inc.
Neurology · 60d
Cleared Jun 15, 2026
VERAFEYE Imaging and Guidance System (VF-VIS-002)
K260885
Luma Vision Limited
Cardiovascular · 90d
Cleared Jun 15, 2026
DRE Duo
K260482 · KPR
Jpi Healthcare Co, Ltd.
Radiology · 122d
Cleared Jun 15, 2026
Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152,...
K260452 · LXB
Zdeer Technology (Henan) Co., Ltd.
Ear, Nose, Throat · 124d
Cleared Jun 15, 2026
Electric Wheelchair (S500-6)
K260335 · ITI
Zhongshan Sulenz Intelligent...
Physical Medicine · 133d