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
11161–11184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 2023
RadianceTx Radionuclide Brachytherapy Source
K223465 · KXK
Radiance Therapeutics, Inc.
Radiology · 55d
Cleared Jan 11, 2023
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
K223719 · KWQ
Aegis Spine, Inc.
Orthopedic · 30d
Cleared Jan 11, 2023
Alpha Control Liner System (ACLS)
K223738 · GXY
Coapt
Neurology · 28d
Cleared Jan 11, 2023
INFINITY OCT System
K223764 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 27d
Cleared Jan 11, 2023
Dexcom G6 Continuous Glucose Monitoring (CGM) System
K223931 · QBJ
Dexcom, Inc.
Chemistry · 12d
Cleared Jan 10, 2023
CoCr Head
K211047 · LPH
Zimmer GmbH
Orthopedic · 642d
Cleared Jan 10, 2023
Metal Cannulated Screw
K221090 · HWC
Double Medical Technology, Inc.
Orthopedic · 272d
Cleared Jan 10, 2023
ISAAC Neurovascular Navigation Catheter
K222115 · DQY
MicroVention, Inc.
Neurology · 176d
Cleared Jan 10, 2023
Haymaker® Screw System
K222799 · HWC
Orthocircle Spine D.B.A. OC Medical...
Orthopedic · 116d
Cleared Jan 09, 2023
Bone Cement Genta, Bone Cement HV, Bone Cement LV
K211163 · LOD
Tecres S.P.A.
Orthopedic · 630d
Cleared Jan 09, 2023
HS186B Scooter
K222711 · INI
Suzhou Master Machinery Manufacturing...
Physical Medicine · 123d
Cleared Jan 09, 2023
Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B,...
K222787 · IYO
Chongqing Sunkingdom Medical...
Radiology · 116d
Cleared Jan 09, 2023
VADER® Pedicle System, G21 Cement
K222789 · PML
Icotec AG
Orthopedic · 116d
Cleared Jan 09, 2023
Vitrea Software Package, VSTP-002A
K223336 · LLZ
Canon Medical Systems Corporation
Radiology · 69d
Cleared Jan 09, 2023
21HQ513D
K223789 · PGY
Lg Electronics.Inc
Radiology · 21d
Cleared Jan 06, 2023
Disposable Surgical Face Mask
K203380 · FXX
Shandong Pop Jeans Intelligent...
General Hospital · 780d
Cleared Jan 06, 2023
BLUEDIAMOND IMPLANT, Abutment Screw
K211812 · DZE
Megagen Implant Co., Ltd.
Dental · 574d
Cleared Jan 06, 2023
T3 Platform software
K213423 · PLB
Etiometry, Inc.
Cardiovascular · 443d
Cleared Jan 06, 2023
CSF-3
K221260 · DPS
Cardiacsense
Cardiovascular · 249d
Cleared Jan 06, 2023
ARTICUL/EZE Ceramic Heads
K222296 · LZO
Depuy Ireland UC
Orthopedic · 158d
Cleared Jan 06, 2023
TECHFIT Diagnostic Models
K222577 · LLZ
Techfit Digital Surgery, Inc.
Radiology · 134d
Cleared Jan 06, 2023
Curiteva Navigation System
K223200 · OLO
Curiteva, Inc.
Orthopedic · 85d
Cleared Jan 06, 2023
LumiVy™ Lumbar IBF System
K223412 · MAX
Vy Spine, LLC
Orthopedic · 58d
Cleared Jan 06, 2023
WatchPAT ONE (WP1)
K223675 · MNR
Itamar Medical , Ltd.
Anesthesiology · 30d