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
6001–6024 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 20, 2024
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit...
K241496 · LNH
Canon Medical Systems Corporation
Radiology · 84d
Cleared Aug 20, 2024
Borvo EVAC System (Ergo)
K241458 · JXG
Borvo Medical, Inc.
Neurology · 89d
Cleared Aug 20, 2024
Luna 4 plus
K241102 · OHS
Foreo, Inc.
General & Plastic Surgery · 120d
Cleared Aug 20, 2024
HYDROS Robotic System
K240200 · PZP
Procept Biorobotics
Gastroenterology & Urology · 208d
Cleared Aug 20, 2024
Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)
K240077 · FLL
Covidien
General Hospital · 223d
Cleared Aug 20, 2024
CUTIVA(TM) Topical Skin Adhesive (RM-1700)
K234114 · MPN
Okapi Medical, LLC Dba Resivant Medical
General & Plastic Surgery · 237d
Cleared Aug 20, 2024
TDS (TECHWIN DENTAL SYSTEM)
K231932 · NHA
Techwin Co., Ltd.
Dental · 417d
Cleared Aug 19, 2024
MT-Bone
K242432 · DZI
Mectron S.P.A.
Dental · 3d
Cleared Aug 19, 2024
OnPoint Augmented Reality Spine System
K241870 · SBF
Onpoint Surgical, Inc.
Orthopedic · 53d
Cleared Aug 19, 2024
iFuse TORQ TNT™ Implant System
K241504 · OUR
SI-BONE, Inc.
Orthopedic · 83d
Cleared Aug 19, 2024
HealthCCSng
K241440 · JAK
Nano-X AI , Ltd.
Radiology · 90d