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
8761–8784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 2023
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic...
K232145 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 103d
Cleared Oct 30, 2023
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
K231965 · IYN
GE Medical Systems Ultrasound and...
Radiology · 119d
Cleared Oct 30, 2023
AOT & T-L Abutment
K231874 · NHA
Truabutment, Inc.
Dental · 126d
Cleared Oct 30, 2023
ClariVy™ Cervical IBF System
K231836 · ODP
Vy Spine, LLC
Orthopedic · 130d
Cleared Oct 30, 2023
Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate...
K231378 · PLP
Insightec , Ltd.
Gastroenterology & Urology · 171d
Cleared Oct 30, 2023
Renova Spine Balloon Catheter
K231340 · NDN
Biopsybell S.R.L.
Orthopedic · 174d
Cleared Oct 30, 2023
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
K231222 · OBO
Topcon Corporation
Ophthalmic · 185d
Cleared Oct 30, 2023
Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl
K231029 · LZA
Zhonghong Pulin Medical Products Co.,...
General Hospital · 202d
Cleared Oct 30, 2023
NuEra Tight RF Model OptiStream
K230755 · PBX
Bios S.R.L.
General & Plastic Surgery · 227d
Cleared Oct 30, 2023
Empatica Health Monitoring Platform
K230457 · MWI
Empatica S.R.L.
Cardiovascular · 251d
Cleared Oct 29, 2023
NextAR™ TSA Platform
K232280 · SBF
Medacta International S.A.
Orthopedic · 90d
Cleared Oct 28, 2023
AcuNav Crystal Ultrasound Catheter
K233270 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 29d
Cleared Oct 28, 2023
Mighty Wire Guide Wire
K230418 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 254d
Cleared Oct 27, 2023
AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm)
K233318 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Oct 27, 2023
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
K233292 · GWF
Inomed Medizintechnik GmbH
Neurology · 28d
Cleared Oct 27, 2023
SOLACE Sacroiliac Fixation System
K233241 · OUR
Ht Medical, LLC Dba Xenix Medical
Orthopedic · 29d
Cleared Oct 27, 2023
EnCor Enspire™Breast Biopsy System (E4115, E4230)
K233220 · KNW
Senorx, Inc.
General & Plastic Surgery · 29d
Cleared Oct 27, 2023
Polaris X™ Unidirectional Steerable Diagnostic Catheter
K233207 · DRF
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Oct 27, 2023
Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)
K233187 · JOJ
Steris
General Hospital · 29d
Cleared Oct 27, 2023
DEKA AGAIN PRO family
K233090 · GEX
El.En S.P.A.
General & Plastic Surgery · 31d
Cleared Oct 27, 2023
OR3O Dual Mobility Liners
K232667 · LPH
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Oct 27, 2023
Aurora Surgiscope System
K232618 · GWG
Rebound Therapeutics Corporation
Neurology · 59d
Cleared Oct 27, 2023
BluTube® Dental Unit Water Purification Cartridge (BluTube®)
K232393 · QYJ
Proedge Dental Products, Inc.
Dental · 79d
Cleared Oct 27, 2023
RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System
K232348 · OVE
MiRus, LLC
Orthopedic · 81d