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
17113–17136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 2021
Single Use Injection Needle
K210917 · FBK
Anrei Medical (Hangzhou) Co., Ltd.
Gastroenterology & Urology · 60d
Cleared May 28, 2021
Axis Charcot Fixation System
K211261 · HWC
Extremity Medical, LLC
Orthopedic · 32d
Cleared May 28, 2021
Pathfinder Endoscope Overtube
K211301 · FED
Neptune Medical, Inc.
Gastroenterology & Urology · 29d
Cleared May 28, 2021
LINQ II Insertable Cardiac Monitor
K211304 · MXD
Medtronic, Inc.
Cardiovascular · 29d
Cleared May 28, 2021
AtriCure Isolator® Synergy™ Surgical Ablation System
K211311 · OCL
AtriCure, Inc.
Cardiovascular · 28d
Cleared May 28, 2021
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3...
K211344 · HCG
Medos International SARL
Neurology · 25d
Cleared May 27, 2021
ZedView
K200704 · LLZ
Lexi Co., Ltd.
Radiology · 435d
Cleared May 27, 2021
Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable...
K201639 · GDW
Beijing Biosis Healing Biolog Ical...
General & Plastic Surgery · 345d
Cleared May 27, 2021
ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content...
K202765 · KGO
Careplus (M) Sdn Bhd
General Hospital · 248d
Cleared May 27, 2021
LigaPASS® Spinal System, CD Horizon™ Spinal System
K211057 · OWI
Medtronic, Inc.
Orthopedic · 48d
Cleared May 27, 2021
BIB Stent Placement Catheter
K211134 · NVM
NuMED, Inc.
Cardiovascular · 41d
Cleared May 27, 2021
Aqua Medical RF Vapor System
K211282 · KNS
Aqua Medical, Inc.
Gastroenterology & Urology · 30d
Cleared May 27, 2021
GalaSTITCH Absorbable Monofilament Suture
K211307 · NWJ
Tepha, Inc.
General & Plastic Surgery · 28d
Cleared May 26, 2021
Implacil Implant System
K202832 · DZE
Implacil DE Bortoli Material...
Dental · 243d
Cleared May 26, 2021
Peak flow meter
K203196 · BZH
Shanghai Sonmol Medical Equipment...
Anesthesiology · 210d
Cleared May 26, 2021
SpyGlass Discover Retrieval Basket
K203322 · LQR
Boston Scientific Corporation
Gastroenterology & Urology · 195d
Cleared CT May 26, 2021
OTE MPS 045 Multi-purpose Lens Care Solution
K210051 · LPN
Ote North America, LLC
Ophthalmic · 138d
Cleared May 26, 2021
Disposable Synthetic Examination Gloves
K210520 · LYZ
Shandong Shengshixincheng Medical...
General Hospital · 92d
Cleared May 26, 2021
Breast Volume Navigator (BVN) Model G-2000
K211098 · IYO
Metritrack, Inc.
Radiology · 43d
Cleared May 26, 2021
ViperCath XC Peripheral Exchange Catheter
K211251 · DQY
Cardiovascular Systems, Inc.
Cardiovascular · 30d
Cleared May 26, 2021
PlasmaWave
K211253 · JOW
Manamed, Inc.
Cardiovascular · 30d
Cleared May 26, 2021
Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System,...
K211258 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 26, 2021
Fassier-Duval Telescopic IM System
K211292 · HSB
Pega Medical, Inc.
Orthopedic · 28d
Cleared May 25, 2021
MicroPen EVO
K203144 · QAI
Eclipse Medcorp, LLC
General & Plastic Surgery · 216d