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
27265–27288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 2017
Rexious Spinal Fixation System
K173131 · NKB
Huvexel Co. , Ltd.
Orthopedic · 70d
Cleared Dec 08, 2017
Wireless Pain Relieve Device Model: LT5018C
K173462 · NUH
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 30d
Cleared Dec 08, 2017
Merge PACS
K173475 · LLZ
Merge Healthcare Incorporated
Radiology · 29d
Cleared Dec 07, 2017
Lilium a-200E
K170046 · IYO
Lilium Otsuka Co., Ltd.
Radiology · 336d
Cleared Dec 07, 2017
Portex Blue Line Ultra Paediatric Tracheosomy Tube
K170720 · JOH
Smiths Medical Asd, Inc.
Anesthesiology · 273d
Cleared Dec 07, 2017
Craniomaxillofacial Distraction System (CMFD)
K170818 · PBJ
Synthes USA Products, LLC
Neurology · 262d
Cleared Dec 07, 2017
NeuViz 16 Essence Multi-slice CT Scanner System
K171198 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 227d
Cleared Dec 07, 2017
Cystoscope 4.0mm autoclavable 0° WL 302mm
K171336 · FAJ
Henke-Sass, Wolf GmbH
Gastroenterology & Urology · 213d
Cleared Dec 07, 2017
Lunderquist Extra Stiff Wire Guide
K171513 · DQX
William Cook Europe Aps
Cardiovascular · 197d
Cleared Dec 07, 2017
gel-e Bandage
K172010 · KGN
Gel-E, Inc. (Formerly Remedium...
General & Plastic Surgery · 157d
Cleared Dec 07, 2017
gammaCore-2
K172270 · PKR
Eletrocore, LLC
Neurology · 132d
Cleared Dec 07, 2017
Equipment Pouch
K172578 · GCJ
Wickimed (Huizhou) Medical Equipment...
General & Plastic Surgery · 101d
Cleared Dec 07, 2017
Single Use Electrosurgical Snare SD-400
K172734 · FDI
Olympus Medical Systems Corp.
Gastroenterology & Urology · 87d
Cleared Dec 07, 2017
Q-Switched Nd:YAG Laser System
K172908 · GEX
Ami, Inc.
General & Plastic Surgery · 73d
Cleared Dec 07, 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 –...
K172912 · LTT
Beckman Coulter, Inc.
Microbiology · 73d
Cleared Dec 07, 2017
Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300...
K173000 · IYN
Shantou Institute of Ultrasonic...
Radiology · 71d
Cleared Dec 07, 2017
NuVasive® VersaTie™ System
K173117 · OWI
Nuvasive, Inc.
Orthopedic · 69d
Cleared Dec 07, 2017
MasterLoc Stem: Lateralized Plus
K173267 · LZO
Medacta International S.A.
Orthopedic · 57d
Cleared Dec 07, 2017
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
K173458 · HSB
Orthofix Srl
Orthopedic · 30d
Cleared Dec 06, 2017
wettrust D2care
K170797 · NUC
Wettrust Korea Co., Ltd.
Obstetrics & Gynecology · 264d
Cleared Dec 06, 2017
C3 Wave System
K170934 · LJS
Medical Components, Inc. (dba MedComp)
General Hospital · 251d
Cleared Dec 06, 2017
OrthoPediatrics Wrist Fusion Plate
K172425 · HRS
Orthopediatrics, Inc.
Orthopedic · 118d
Cleared Dec 06, 2017
091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm
K172468 · DQY
Inneuroco, Inc.
Cardiovascular · 113d
Cleared Dec 06, 2017
BEAUTIFIL Flow Plus X
K172530 · EBF
Shofu Dental Corporation
Dental · 107d