FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: 2026–2026 ×
2,517 results
121–144 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Sep 23, 2026
Everslide
K260117 · NUC
Special Situations, LLC
Obstetrics & Gynecology · 252d
Cleared Sep 23, 2026
Portable Oxygen Concentrator (OX-1A-E, OX-1B)
K254289 · CAW
Oxytek Medical Technology Co., Ltd.
Anesthesiology · 266d
Cleared Sep 22, 2026
BIOFIRE Respiratory Panel 2.1 (RP2.1)
K263054 · QOF
Biofire Diagnostics
Microbiology · 21d
Cleared Sep 22, 2026
HipStudio Analysis
K262442 · LLZ
Replasia BV
Radiology · 68d
Cleared Sep 22, 2026
BoneXpert
K262390 · QIH
Visiana
Radiology · 71d
Cleared Sep 22, 2026
Instant-View® hCG Combo II Cassette Test
K262299 · JHI
Alfa Scientific Designs, Inc.
Chemistry · 77d
Cleared Sep 22, 2026
BodyTom 64 (NL4100)
K261125 · JAK
Samsung HME America, Inc., dba...
Radiology · 169d
Cleared Sep 22, 2026
Echo-2
K254240 · QOK
Neko Health AB
Cardiovascular · 267d
Cleared Sep 22, 2026
Actolind® (06.3637. Actolind® Gel Plus)
K254168 · FRO
ACTO GmbH
General & Plastic Surgery · 273d
Cleared Sep 22, 2026
ErgoSteel (ES0001/696)
K253762 · IOR
Strongback Mobility AG C/O Blueaudit...
Physical Medicine · 301d
Cleared Sep 22, 2026
Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)
K243223 · PBX
Bh Group Us, LLC
General & Plastic Surgery · 715d
Cleared Sep 21, 2026
Core·it Dual
K262982 · EBF
Spident Co., Ltd.
Dental · 25d
Cleared Sep 21, 2026
KARL STORZ TIPCAM1 Rubina
K262547 · OWN
KALR STORZ SE & Co. KG
Cardiovascular · 60d
Cleared Sep 21, 2026
Access NT-proBNP
K262109 · NBC
Beckman Coulter, Inc.
Chemistry · 90d
Cleared Sep 21, 2026
FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin)
K262108 · HIS
Shanghai Personage Hygiene Products...
Obstetrics & Gynecology · 90d
Cleared Sep 21, 2026
OtoCompanion (Version 1.0)
K261725 · SHL
Ironsides Medical, Inc.
Ear, Nose, Throat · 118d
Cleared Sep 21, 2026
Rapid Platform (R6.7)
K261368 · QIH
Ischemaview, Inc.
Radiology · 147d
Cleared Sep 21, 2026
BellaTek Bars
K260940 · NHA
ZimVie US Corp, LLC
Dental · 185d
Cleared Sep 21, 2026
ZYLOX Hippo PTA Balloon Dilatation Catheter
K260416 · LIT
Zylox Medtech Co., Ltd.
Cardiovascular · 224d
Cleared Sep 21, 2026
F.A.S.T Screw
K254280 · HWC
Steps Ortho
Orthopedic · 265d
Cleared Sep 21, 2026
TriSalus TriNav Advance Infusion System
K253509 · KRA
Trisalus Life Sciences
Cardiovascular · 320d
Cleared Sep 19, 2026
Electric Scooter (FDB08, FDB08A, FDB12)
K261859 · INI
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 107d
Cleared Sep 19, 2026
Dynamis Pro Family
K252723 · GEX
Fotona D.O.O.
General & Plastic Surgery · 387d
Cleared Sep 18, 2026
CrossFAST Integrated Microcatheter Advanced Delivery System
K262817 · DQY
Vantis Vascular, Inc.
Cardiovascular · 42d