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
9721–9744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 2023
HS Fiber Cerclage
K220765 · JDQ
Riverpoint Medical, LLC
Orthopedic · 497d
Cleared Jul 25, 2023
EZ-IO Intraosseous Vascular Access System
K231924 · FMI
Teleflex Medical
General Hospital · 25d
Cleared Jul 25, 2023
A-TAP (previously called Arthrotap)
K231900 · FMF
Elcam Medical Acal
General Hospital · 27d
Cleared Jul 25, 2023
Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN...
K231878 · FGB
STERIS Corporation
Gastroenterology & Urology · 29d
Cleared Jul 25, 2023
Reprocessed ViewFlex Xtra ICE Catheter (D087031)
K231621 · OWQ
Stryker Sustainability Solutions
Cardiovascular · 53d
Cleared Jul 25, 2023
MOBILETT Impact
K231577 · IZL
Siemens Medical Solutions
Radiology · 55d
Cleared Jul 25, 2023
Exceed™ Biplanar Expandable Interbody System
K231275 · MAX
Spine Wave, Inc.
Orthopedic · 84d
Cleared Jul 25, 2023
ANDI
K230913 · QIH
Imeka Solutions, Inc.
Radiology · 116d
Cleared Jul 25, 2023
Apyx
K230730 · PBQ
Escala Medical
Obstetrics & Gynecology · 131d
Cleared Jul 25, 2023
IDENTIFY
K230576 · IYE
Varian Medical Systems, Inc.
Radiology · 146d
Cleared Jul 25, 2023
Patient Specific Planning Solution™ 3D Bone Models
K230540 · LLZ
Biomet Manufacturing Corp
Radiology · 148d
Cleared Jul 25, 2023
Enamel Coating Resin
K230455 · EBC
Rizhao Huge Biomaterials Company, Ltd.
Dental · 154d
Cleared Jul 25, 2023
Sonio Detect
K230365 · IYN
Sonio
Radiology · 165d
Cleared Jul 25, 2023
ME-APDS™
K223473 · QNP
Magentiq Eye, Ltd.
Gastroenterology & Urology · 250d
Cleared Jul 25, 2023
A-LYTE® Integrated Multisensor (IMT Na K Cl)
K222438 · JGS
Siemens Healthcare Diagnostics, Inc.
Chemistry · 347d
Cleared Jul 25, 2023
Emit® II Plus Buprenorphine Assay
K221605 · DJG
Siemens Healthcare Diagnostics, Inc.
Toxicology · 418d
Cleared Jul 25, 2023
DEKA ACE Pump System
K213536 · QFG
Deka Research and Development
Chemistry · 627d
Cleared Jul 24, 2023
EsCom250
K231523 · EBF
Spident Co., Ltd.
Dental · 59d
Cleared Jul 24, 2023
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish...
K230333 · LBH
Kettenbach GmbH & Co. KG
Dental · 167d
Cleared Jul 24, 2023
Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with...
K223752 · LZA
Central Medicare Sdn Bhd
General Hospital · 221d
Cleared Jul 24, 2023
UltraSight AI Guidance
K223347 · QJU
Ultrasight, Inc.
Radiology · 265d
Cleared Jul 24, 2023
Argus Cognitive ReVISION Software
K223322 · LLZ
Argus Cognitive, Inc.
Radiology · 266d
Cleared Jul 23, 2023
Atlan
K230931 · BSZ
Dr?gerwerk AG & Co KGaA
Anesthesiology · 111d
Cleared Jul 21, 2023
TruDi® Navigation System V3 (FG-2000-00)
K231862 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 28d