FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
6265–6288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 2024
LIJIA Night Guard
K241369 · MQC
Lijia, LLC
Dental · 100d
Cleared Aug 22, 2024
Single-use Sterile High-pressure Angiographic Syringes and Accessories
K241109 · DXT
Shenzhen Boon Medical Supply Co., Ltd.
General Hospital · 122d
Cleared Aug 22, 2024
NeuroQuant
K241098 · QIH
Cortechs Labs, Inc.
Radiology · 122d
Cleared Aug 22, 2024
LiNA CystoVu™ HD (CYV-100-5
K240227 · FAJ
Lina Medical Aps
Gastroenterology & Urology · 209d
Cleared Aug 22, 2024
Phantom Fibula Nail System
K234128 · HSB
Paragon 28, Inc.
Orthopedic · 238d
Cleared Aug 22, 2024
iCare ALTIUS CW
K234076 · NFJ
Centervue S.P.A.
Ophthalmic · 245d
Cleared Aug 22, 2024
Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking...
K230071 · HSB
Tdm Co., Ltd.
Orthopedic · 590d
Cleared Aug 21, 2024
Fraxel® FTX Laser System
K242142 · GEX
Solta Medical
General & Plastic Surgery · 30d
Cleared Aug 21, 2024
TiLink-P SI Joint Fusion System
K242141 · OUR
SurGenTec, LLC
Orthopedic · 30d
Cleared Aug 21, 2024
iSage Rx
K242066 · NDC
Amalgam Rx, Inc.
Chemistry · 37d
Cleared Aug 21, 2024
Blood Pressure Monitor (TMB-2092-G)
K241351 · DXN
Guangdong Transtek Medical...
Cardiovascular · 100d
Cleared Aug 21, 2024
Kerecis Parvus (50207)
K241080 · KGN
Kerecis Limited
General & Plastic Surgery · 124d
Cleared Aug 21, 2024
VERSA Negative Pressure Wound Therapy System (VCMPP-100)
K241061 · OMP
Cork Medical
General & Plastic Surgery · 125d
Cleared Aug 21, 2024
Glidewire GT-R
K240859 · DQX
Terumo Corporation
Cardiovascular · 146d
Cleared Aug 21, 2024
MULA (K2-A1)
K240314 · ONF
Guangzhou Ciellulu Photoelectric...
General & Plastic Surgery · 201d
Cleared Aug 21, 2024
Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo
K240298 · FRO
Bionova Medical, Inc.
General & Plastic Surgery · 202d
Cleared Aug 21, 2024
AiMIFY (1.x)
K240290 · LLZ
Subtle Medical, Inc.
Radiology · 202d
Cleared Aug 21, 2024
Montage-XT Settable, Resorbable Bone Putty
K233566 · MQV
Orthocon, Inc.
Orthopedic · 289d
Cleared Aug 21, 2024
cCeLL - In vivo
K233391 · GWG
VPIX Medical, Inc.
Neurology · 324d
Cleared Aug 21, 2024
Nalu Neurostimulation System for Peripheral Nerve Stimulation
K232415 · GZF
Boston Scientific Neuromodulation
Neurology · 376d
Cleared Aug 20, 2024
CELERITY HP Indicator Tape (PCC077)
K242189 · JOJ
Steris
General Hospital · 26d
Cleared Aug 20, 2024
ClearCap Distal Attachment
K242134 · OCX
Finemedix Co., Ltd.
Gastroenterology & Urology · 29d
Cleared Aug 20, 2024
MedtFine Safety Lancet
K241848 · FMK
Ningbo Caremed Medical Products Co.,...
General & Plastic Surgery · 54d
Cleared Aug 20, 2024
PYXIS 3D Titanium Cervical Cage system
K241738 · ODP
GS Medical Co., Ltd.
Orthopedic · 64d