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
9361–9384 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 2023
TiLink-L Joint Fusion System
K231831 · OUR
Surgentec
Orthopedic · 42d
Cleared Aug 03, 2023
NorthStar OCT System
K231654 · NKG
Seaspine, Inc.
Orthopedic · 58d
Cleared Aug 03, 2023
Medical Diode Laser, Model S1Pro
K231548 · GEX
Wuhan Pioon Technology Co., Ltd.
General & Plastic Surgery · 65d
Cleared Aug 03, 2023
Extremity Staple
K231458 · JDR
Restor3d
Orthopedic · 76d
Cleared Aug 03, 2023
Sequel Tampon with Plastic Applicator
K230419 · HEB
Tampro, Inc.
Obstetrics & Gynecology · 168d
Cleared Aug 03, 2023
Surgical Face Masks, Model: EFMDS-L50Pn BLU
K230380 · FXX
Iris USA
General Hospital · 171d
Cleared Aug 03, 2023
Sterile Water for Inhalation in 1L Flexoval ® bottles.
K223551 · BTT
Hometa, Inc.
Anesthesiology · 251d
Cleared Aug 03, 2023
TubaVent Balloon Dilatation System
K223542 · PNZ
Spiggle & Theis Medizintechnik GmbH
Ear, Nose, Throat · 251d
Cleared Aug 03, 2023
VisiRad XR
K223133 · MYN
Imidex, Inc.
Radiology · 304d
Cleared Aug 03, 2023
MENIX®
K223122 · GAT
S.B.M. Sas (Science & Bio Materials)
General & Plastic Surgery · 304d
Cleared Aug 03, 2023
Lumbar Expandable lnterbody Spacers -Additional Indications/Implants
K221894 · MAX
Globus Medical, Inc.
Orthopedic · 399d
Cleared Aug 02, 2023
Ingenia Elition R5.7.1 SP4 MR Systems
K232030 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 26d
Cleared Aug 02, 2023
Mineral Collagen Composite Bioactive Extra Moldable
K231942 · MQV
Collagen Matrix, Inc.
Orthopedic · 33d
Cleared Aug 02, 2023
Sapphire X3 Anterior Cervical Plate System
K231593 · KWQ
Spinal Elements, Inc.
Orthopedic · 62d
Cleared Aug 02, 2023
ActivSight Intraoperative Imaging System
K231344 · OWN
Activ Surgical, Inc.
General & Plastic Surgery · 85d
Cleared Aug 02, 2023
Chemfort® Catheter Adaptor
K231286 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 90d
Cleared Aug 02, 2023
BPBIO750
K231174 · DXN
Inbody Co., Ltd.
Cardiovascular · 99d
Cleared Aug 02, 2023
Eblator Device
K231126 · GEI
E Surgical, LLC
General & Plastic Surgery · 104d
Cleared Aug 02, 2023
Disposable Ureteral Access Sheath
K230748 · FED
Youcare Technology Co.,Ltd. (Wuhan)
Gastroenterology & Urology · 138d
Cleared Aug 02, 2023
SKEEPER
K230613 · DQD
Smartsound Corporation
Cardiovascular · 149d
Cleared Aug 02, 2023
Self-Cath Closed System
K223821 · FCM
Coloplast
Gastroenterology & Urology · 224d
Cleared Aug 02, 2023
Disposable Needle Guides and Grids
K223689 · ITX
Advance Medical Designs, Inc.
Radiology · 236d
Cleared Aug 02, 2023
Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
K223553 · OLO
Brainlab AG
Orthopedic · 250d
Cleared Aug 02, 2023
Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors
K223114 · MBI
Gm Dos Reis Industria E Comerico Ltda.
Orthopedic · 303d