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
25369–25392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 2018
JGH1 Core Deccompression Procedure Kit
K181585 · MQV
AgNovos Healthcare USA, LLC
Orthopedic · 35d
Cleared Jul 20, 2018
Digital Diagnostic Mobile X-ray System
K181626 · IZL
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Jul 20, 2018
GC85A
K181629 · KPR
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Jul 20, 2018
GR40CW
K181631 · MQB
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Jul 20, 2018
Aurora
K181636 · MUH
Sodium Systems, LLC
Radiology · 29d
Cleared Jul 20, 2018
Bandit guidewire
K181647 · DQX
Vascular Solutions, Inc.
Cardiovascular · 28d
Cleared Jul 19, 2018
Disposable Electrosurgical Pencils
K170369 · GEI
Cathay Manfacturing Corp.
General & Plastic Surgery · 528d
Cleared Jul 19, 2018
Atellica IM High-Sensitivity Troponin I (TNIH)
K171566 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 415d
Cleared Jul 19, 2018
Latitud Hip Replacement System
K172857 · LPH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 302d
Cleared Jul 19, 2018
da Vinci Xi Surgical System, da Vinci X Surgical System
K173585 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 241d
Cleared Jul 19, 2018
Medline Burn and Wound Dressing
K173911 · FRO
Medline Industries, Inc.
General & Plastic Surgery · 209d
Cleared Jul 19, 2018
Ultrasonic Doppler (Model YM-2T8)
K180419 · KNG
Shenzhen Imdk Medical Technology Co.,...
Obstetrics & Gynecology · 154d
Cleared Jul 19, 2018
DentiqGuide
K180629 · LLZ
3D Industrial Imaging Co., Ltd.
Radiology · 132d
Cleared Jul 19, 2018
CuffLink Implant System Biocomposite
K180763 · MAI
Conmed Corporation
Orthopedic · 118d
Cleared Jul 19, 2018
JGH1 Bone Graft Substitute
K181342 · MQV
AgNovos Healthcare USA, LLC
Orthopedic · 59d
Cleared Jul 19, 2018
Image Filing Software NAVIS-EX
K181345 · NFJ
Nidek Co., Ltd.
Ophthalmic · 59d
Cleared Jul 19, 2018
Clarifi Imaging System
K181623 · MUD
Modulated Imaging, Inc.
Cardiovascular · 29d
Cleared Jul 19, 2018
Ultimax-i, DREX-UI80 (V1.60)
K181834 · OWB
Canon Medical Systems Corporation
Radiology · 9d
Cleared Jul 18, 2018
Capnograph and Oximeter
K170820 · CCK
Cmi Health, Inc.
Anesthesiology · 485d
Cleared Jul 18, 2018
PENTAX Medical VIVIDEO ENT Videoscope Solution
K171011 · EOB
Pentax Medical
Ear, Nose, Throat · 470d
Cleared Jul 18, 2018
ePTFE-Coated Auricular Implant
K172389 · FZD
Implantech Associates, Inc.
General & Plastic Surgery · 344d
Cleared Jul 18, 2018
Power Infuser
K172653 · FRN
ZOLL Medical Corporation
General Hospital · 316d
Cleared Jul 18, 2018
DIP/U.S. Urine Analysis Test System
K173327 · JIL
Healthy.Io, Ltd.
Chemistry · 271d
Cleared Jul 18, 2018
CarboClear® Pedicle Screw System
K173487 · NKB
CarboFix Orthopedics , Ltd.
Orthopedic · 247d