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

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175,820 results
14233–14256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 2022
Astroglide Glycerin & Paraben Free
K220653 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 60d
Cleared May 06, 2022
NewTom 7G
K220664 · JAK
Cefla S.C.
Radiology · 60d
Cleared May 06, 2022
Vatech Clismile
K220689 · NJM
Rayence Co., Ltd.
Dental · 58d
Cleared May 06, 2022
Invu by Nuvo
K221046 · LQK
Nuvo- Group , Ltd.
Obstetrics & Gynecology · 28d
Cleared May 05, 2022
PosiSep EAR Fragmentable Ear Dressing
K210411 · NHB
Hemostasis, LLC
Ear, Nose, Throat · 448d
Cleared May 05, 2022
Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1,...
K210565 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 434d
Cleared May 05, 2022
NAVIRFA Scope
K211529 · IYO
Navifus Corporation
Radiology · 353d
Cleared May 05, 2022
Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618
K212346 · FLL
Shenzhen Pango Medical Electronics...
General Hospital · 281d
Cleared May 05, 2022
Neuromuscular Transmission Monitor TOF3D
K212434 · KOI
MIPM Mammendorfer Institut f?r Physik...
Anesthesiology · 274d
Cleared May 05, 2022
Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set
K212756 · OLO
Medos International SARL
Orthopedic · 247d
Cleared May 05, 2022
HandPICO
K220041 · GEX
Vydence Medical Industria E Comercio...
General & Plastic Surgery · 120d
Cleared May 05, 2022
17HQ901G-B
K220559 · MQB
Lg Electronics.Inc
Radiology · 66d
Cleared May 05, 2022
HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx
K220685 · NFT
Qingdao Hightop Biotech Co., Ltd.
Toxicology · 58d
Cleared May 05, 2022
LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension
K220691 · DQY
Seigla Medical, Inc.
Cardiovascular · 57d
Cleared May 05, 2022
Spartan SC 069
K220716 · DQY
Spartan Micro, Inc.
Neurology · 55d
Cleared May 05, 2022
GIA Auto Suture Stapler with DST Series Technology
K221013 · GDW
Covidien
General & Plastic Surgery · 30d
Cleared May 05, 2022
Steriking Packaging for Medical Devices
K221016 · FRG
Wipak OY
General Hospital · 30d
Cleared May 05, 2022
AcQGuide® VUE Steerable Sheath
K221044 · DRA
Acutus Medical, Inc.
Cardiovascular · 27d
Cleared May 05, 2022
Viatrac 14 Plus Peripheral Dilatation Catheter
K221057 · LIT
Abbott Vascular
Cardiovascular · 24d
Cleared CT May 04, 2022
LiveOne
K201302 · DXN
Livemetric (Medical) S.A.
Cardiovascular · 719d
Cleared May 04, 2022
Plus Medical Chemotherapy Gown
K211036 · FYA
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 392d
Cleared May 04, 2022
BioTeke Sterile Disposable Virus Sampling Kit
K211707 · JSM
Bioteke Corporation (Wuxi) Co., Ltd.
Microbiology · 335d
Cleared May 04, 2022
Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231,...
K212257 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 289d
Cleared May 04, 2022
Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida...
K212588 · DQY
C.R. Bard, Inc.
Cardiovascular · 261d