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
13729–13752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 27, 2022
Philips Incisive CT
K212441 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 266d
Cleared Apr 27, 2022
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy...
K213040 · LZA
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 217d
Cleared Apr 27, 2022
Automatically Retractable Safety Syringe
K213077 · MEG
Zhejiang Lingyang Medical Apparatus...
General Hospital · 216d
Cleared Apr 27, 2022
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
K213236 · PEN
Genmark Diagnostics, Incorporated
Microbiology · 209d
Cleared Apr 27, 2022
Tomey Cornea/Anterior Segment OCT CASIA2
K213265 · OBO
Tomey Corporation
Ophthalmic · 209d
Cleared Apr 27, 2022
GyroStim
K220231 · LXV
Ultrathera Technologies, Inc.
Ear, Nose, Throat · 90d
Cleared Apr 27, 2022
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral...
K220568 · MCW
Cardiovascualr Systems, Inc.
Cardiovascular · 58d
Cleared Apr 27, 2022
Venus BlissMAX
K220592 · PBX
Venus Concept USA, Inc.
General & Plastic Surgery · 57d
Cleared Apr 27, 2022
EXTesia Introducer Sheath Set
K220604 · DYB
Curatia Medical Co.
Cardiovascular · 56d
Cleared Apr 27, 2022
Hand-held IPL device (JOVS Hair Removal Device)
K220645 · OHT
Shenzhen Qianyu Technology Co., Ltd.
General & Plastic Surgery · 54d
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