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
14953–14976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 2022
SIGNA Artist Evo
K213603 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 88d
Cleared Feb 11, 2022
Surgical Face Mask
K213617 · FXX
Megasoft (China) Co., Ltd.
General Hospital · 88d
Cleared Feb 11, 2022
B. Braun Introcan Safety 2 IV Catheter
K213664 · FOZ
B.Braun Medical, Inc.
General Hospital · 81d
Cleared Feb 11, 2022
MAVERICK External Fixation System
K213874 · JDW
Smith & Nephew, Inc.
Orthopedic · 60d
Cleared Feb 11, 2022
IMICRYL Impression Materials
K213890 · ELW
Imicryl Dis Malzemeleri San. VE Tic....
Dental · 60d
Cleared Feb 10, 2022
NervAlign Nerve Cuff
K202234 · JXI
Renerve, Ltd.
Neurology · 552d
Cleared Feb 10, 2022
Action Trackchair Hawk
K202728 · IPL
Action Manufacturing, Inc.
Physical Medicine · 510d
Cleared Feb 10, 2022
Micro Catheter
K202926 · QJP
Shanghai Heartcare Medical Technology...
Neurology · 499d
Cleared Feb 10, 2022
GPC Intraheal Intramedullary Nailing System
K203811 · HSB
Gpc Medical Limited
Orthopedic · 409d
Cleared Feb 10, 2022
Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed...
K211327 · DRF
CathRx, Ltd.
Cardiovascular · 283d
Cleared Feb 10, 2022
Zeolite Hemostatic Gauze
K211570 · QSY
Hangzhou Zeo-Innov Life Technology...
General & Plastic Surgery · 265d
Cleared Feb 10, 2022
NPseal
K212971 · OKO
Guard Medical, Inc.
General & Plastic Surgery · 146d
Cleared Feb 10, 2022
Instylla Delivery Kit
K213632 · FMF
Instylla, Inc.
General Hospital · 85d
Cleared Feb 10, 2022
Pure-Vu EVS System
K220007 · FDF
Motus GI Medical Technologies , Ltd.
Gastroenterology & Urology · 37d
Cleared Feb 09, 2022
Infrascanner
K211617 · OPT
Infrascan, Inc.
Neurology · 259d
Cleared CT Feb 09, 2022
R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire,...
K212167 · DQX
Vascular Solutions, LLC
Cardiovascular · 212d
Cleared CT Feb 09, 2022
Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike...
K212211 · DQY
Vascular Solutions, LLC
Cardiovascular · 209d
Cleared Feb 09, 2022
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
K212213 · PQA
Cepheid
Microbiology · 209d
Cleared CT Feb 09, 2022
CloudCath Peritoneal Dialysis Drain Set Monitoring System
K212658 · FKX
Cloudcath
Gastroenterology & Urology · 170d
Cleared Feb 09, 2022
Actively Trying Personal Lubricant Unfragrance
K212705 · PEB
CC Wellness, LLC
Obstetrics & Gynecology · 167d
Cleared Feb 09, 2022
Redline
K213297 · NXC
Johns Dental Laboratories
Dental · 131d
Cleared Feb 09, 2022
Lucy Breast Pump
K213311 · HGX
Willow Innovations, Inc.
Obstetrics & Gynecology · 128d
Cleared Feb 09, 2022
Veinoflow SCD (Model: LBTK-M-I 5006)
K213313 · JOW
Dalian Labtek Science & Development...
Cardiovascular · 128d
Cleared Feb 09, 2022
PELNAC Wound Matrix
K213573 · KGN
Gunze Limited
General & Plastic Surgery · 91d