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: Cleared only ×
175,820 results
14329–14352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 2022
ExsoMed INnate NanoTM Lag Screw System
K220892 · HWC
Exsomed Corp.
Orthopedic · 30d
Cleared Apr 27, 2022
Strados Remote Electronic Stethoscope Platform (RESP)
K220893 · DSH
Strados Labs, Inc.
Anesthesiology · 30d
Cleared Apr 27, 2022
NOxBOXi Nitric Oxide Delivery System
K220898 · MRN
Linde Gas & Equipment, Inc.
Anesthesiology · 30d
Cleared Apr 26, 2022
SpeedCath Compact Male
K210250 · EZD
Coloplast
Gastroenterology & Urology · 452d
Cleared Apr 26, 2022
ManaSport
K210284 · IMI
Manamed, Inc.
Physical Medicine · 448d
Cleared Apr 26, 2022
AliveCor QT Service
K212662 · DQK
AliveCor, Inc.
Cardiovascular · 246d
Cleared Apr 26, 2022
SnapLoc Wire Lock
K213483 · ODC
Wilson Cook Medical
Gastroenterology & Urology · 179d
Cleared Apr 26, 2022
BriefCase
K213886 · QAS
Aidoc Medical , Ltd.
Radiology · 134d
Cleared Apr 26, 2022
PERMALOOP Suture, PERMATAPE Suture
K220219 · GAT
Medos International SARL
General & Plastic Surgery · 90d
Cleared Apr 26, 2022
IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
K220222 · OHT
Shenzhen Yuwei Electronic Technology...
General & Plastic Surgery · 90d
Cleared Apr 26, 2022
Disposable Medical Face Mask
K220487 · FXX
Hubei Mediunion Medical Products Co.,...
General Hospital · 63d
Cleared Apr 26, 2022
M.U.S.T. MINI Posterior Cervical Screws System Extension
K220570 · NKG
Medacta International S.A.
Orthopedic · 57d
Cleared Apr 26, 2022
Legion Inserts with JRNY Lock
K220896 · JWH
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Apr 25, 2022
CER-S
K213861 · DQK
Cardiocalm Srl
Cardiovascular · 136d
Cleared Apr 25, 2022
MyoCycle MC-2 (Home / Home + / Pro / Pro +)
K213925 · GZI
Myolyn, LLC
Neurology · 130d
Cleared Apr 25, 2022
Disposable Surgical Face Mask (M01, M02)
K220512 · FXX
Fomed Industries, Inc.
General Hospital · 62d
Cleared Apr 25, 2022
Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
K221041 · PPN
Shockwave Medical, Inc.
Cardiovascular · 17d
Cleared Apr 24, 2022
IVX Fluid Transfer Set
K212530 · LHI
Omnicell, Inc.
General Hospital · 256d
Cleared Apr 24, 2022
Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves
K213775 · LYY
Avecena Gloves Sdn Bhd
General Hospital · 143d
Cleared Apr 23, 2022
TENS device-EmeTerm 2, Model: YF-ZTY-E2
K220503 · GZJ
Wat Medical Technology, Inc.
Neurology · 60d
Cleared CT Apr 22, 2022
CoNextions TR Tendon Repair System
K203855 · GAQ
Conextions Medical
General & Plastic Surgery · 477d
Cleared Apr 22, 2022
LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
K211123 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 372d
Cleared Apr 22, 2022
F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
K212031 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 297d
Cleared Apr 22, 2022
Electric Scooter
K212090 · INI
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 290d