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
5737–5760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 2024
Vitesse (5.0)
K241876 · MUJ
Varian Medical Systems
Radiology · 117d
Cleared Oct 23, 2024
Immediate Molar Implants
K241753 · DZE
Biomet 3i, LLC
Dental · 127d
Cleared Oct 23, 2024
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
K241324 · SAN
Affinity Biosensors, LLC
Microbiology · 166d
Cleared Oct 23, 2024
IDS-iSYS Free Testosterone
K240865 · CDZ
Immunodiagnostic Systems Limited
Chemistry · 209d
Cleared Oct 23, 2024
Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C,...
K240289 · EOQ
Scivita Medical Technology Co., Ltd.
Ear, Nose, Throat · 265d
Cleared Oct 23, 2024
KIDNEYvault Portable Renal Perfusion System
K234060 · KDN
Paragonix Technologies
Gastroenterology & Urology · 306d
Cleared Oct 22, 2024
nordicMEDiVA
K243209 · LLZ
Nordicneurolab AS
Radiology · 21d
Cleared Oct 22, 2024
PuraStat
K242250 · QAU
3-D Matrix Europe SAS
General & Plastic Surgery · 83d
Cleared Oct 22, 2024
Arm Type Blood Pressure Monitor (BPM82)
K242193 · DXN
Avita Corporation
Cardiovascular · 88d
Cleared Oct 22, 2024
Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without...
K242099 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 96d
Cleared Oct 22, 2024
Reprocessed RD SET Adt Pulse Oximeter Sensor (4000)
K241758 · NLF
Stryker Sustainability Solutions
Anesthesiology · 124d
Cleared Oct 22, 2024
ARTIS icono (VE40A) (floor)
K241572 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 144d
Cleared Oct 22, 2024
Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)
K241532 · FET
Shanghai SeeGen Photoelectric...
Gastroenterology & Urology · 145d
Cleared Oct 22, 2024
Tri-Wedge PTA Scoring Balloon Dilatation Catheter
K241478 · PNO
Brosmed Medical Co., Ltd.
Cardiovascular · 151d
Cleared Oct 22, 2024
SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses
K241398 · HQD
Tianjin Mastervision Technology Co.,...
Ophthalmic · 159d
Cleared Oct 22, 2024
KARL STORZ Holders
K240506 · OCV
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 244d
Cleared Oct 21, 2024
Arthrex VAL and VAL KreuLock™ Compression Screw System
K242554 · HRS
Arthrex, Inc.
Orthopedic · 55d
Cleared Oct 21, 2024
PhotonBlade 3
K242266 · GEI
Stryker Instruments
General & Plastic Surgery · 81d
Cleared Oct 21, 2024
Anovo Surgical System (Model 6Ne)
K242157 · QNM
Momentis Surgical , Ltd.
General & Plastic Surgery · 90d
Cleared Oct 21, 2024
Digital Prism Correction Feature (DPCF)
K242058 · SCW
Apple, Inc.
Ophthalmic · 98d
Cleared Oct 21, 2024
Dynamic TiBase
K241170 · NHA
Talladium Espa?a, SL
Dental · 178d
Cleared Oct 21, 2024
Anthology Hip Stems
K240783 · JDI
Smith & Nephew, Inc.
Orthopedic · 214d
Cleared Oct 21, 2024
Zio AT® device (A100A1001)
K240029 · QYX
iRhythm Technologies, Inc.
Cardiovascular · 291d
Cleared Oct 21, 2024
Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag...
K222740 · FRO
Speciality Fibres and Materials, Ltd.
General & Plastic Surgery · 773d