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
17161–17184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 2021
Rover
K211423 · IZL
Micro-X Limited
Radiology · 14d
Cleared May 20, 2021
Ignite Anatomic Shoulder System
K202716 · MBF
Ignite Orthopedics, LLC
Orthopedic · 245d
Cleared May 20, 2021
Procedure Mask, Surgical Mask
K202899 · FXX
Kenpax International Limited
General Hospital · 233d
Cleared May 20, 2021
ATS 5000 Automatic Tourniquet Instrument
K202919 · KCY
Mcewen and Associates Consulting , Ltd.
General & Plastic Surgery · 233d
Cleared May 20, 2021
Quick-20m
K203331 · GWL
Cgx, LLC
Neurology · 189d
Cleared CT May 20, 2021
VR101 Lubricating Intravaginal Ring
K203377 · QPD
J3 Bioscience, Inc.
Obstetrics & Gynecology · 184d
Cleared May 20, 2021
Surgical Isolation Gown
K203415 · FYC
Yanbian Pacific Textile Co., Ltd.
General Hospital · 182d
Cleared May 20, 2021
Penumbra System (Reperfusion Catheter RED 62)
K203440 · NRY
Penumbra, Inc.
Neurology · 178d
Cleared May 20, 2021
YUWELL infrared ear thermometer: YHT101, YHT200
K203583 · FLL
Jiangsu Yuyue Medical Equipment&...
General Hospital · 163d
Cleared May 20, 2021
Vitals360 Multi-Vitals Mobile Monitor
K210086 · MWI
Vocare, Inc.
Cardiovascular · 127d
Cleared May 20, 2021
Xoran Workstation, Model 10050
K210257 · LLZ
Xoran Technologies, LLC
Radiology · 108d
Cleared May 20, 2021
EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound...
K210476 · FCG
Cook Ireland, Ltd.
Gastroenterology & Urology · 90d
Cleared May 20, 2021
Actis DuoFix Hip Prosthesis- Collarless
K210581 · MEH
Depuy Ireland UC
Orthopedic · 83d
Cleared May 20, 2021
C-Qual M™ Breastboard
K211001 · IYE
Medtec, Inc. Dba Civco Medical...
Radiology · 48d
Cleared May 19, 2021
CUVIS-spine
K201569 · OLO
Curexo, Inc.
Orthopedic · 342d
Cleared May 19, 2021
Disposable Latex Powder Free Examination Gloves (Non-sterile)
K201576 · LYY
Pt. Universal Gloves
General Hospital · 342d
Cleared May 19, 2021
Turbett Instrument Pod
K202593 · FRG
Turbett Surgical, Inc.
General Hospital · 253d
Cleared May 19, 2021
TENS & EMS Device
K202866 · NUH
Shenzhen Jian Feng Electronic...
Physical Medicine · 233d
Cleared CT May 19, 2021
Contour Light CL-100
K202955 · OLI
Contour Research, LLC
General & Plastic Surgery · 231d
Cleared May 19, 2021
TECHFIT Patient-Specific Maxillofacial System
K203282 · JEY
Industrias Medicas Sampedro S.A.S
Dental · 194d
Cleared May 19, 2021
Overjet Dental Assist
K210187 · LLZ
Overjet, Inc.
Radiology · 114d
Cleared May 19, 2021
CINA CHEST
K210237 · QAS
Avicenna.Ai
Radiology · 111d
Cleared May 19, 2021
GII Spinal Fixation System
K210306 · NKB
Coligne AG
Orthopedic · 105d
Cleared May 19, 2021
Electrosurgical accessory
K210394 · FAS
Dornier Medtech America, Inc.
Gastroenterology & Urology · 98d