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

Filters: Cleared only ×
175,820 results
23329–23352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 2019
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile,...
K183287 · LZA
Kossan International Sdn Bhd
General Hospital · 130d
Cleared Apr 05, 2019
EkoSonic Endovascular Device with Control Unit 4.0
K183361 · QEY
Btg International, Inc.
Cardiovascular · 122d
Cleared Apr 05, 2019
R190/R191 LCD Monitor
K183494 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 109d
Cleared Apr 05, 2019
Xbody Newave USA
K190038 · NGX
Xbody Hungary Kft.
Physical Medicine · 87d
Cleared Apr 05, 2019
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature...
K190103 · MLR
STERIS Corporation
General Hospital · 73d
Cleared Apr 05, 2019
Amplatzer Trevisio Intravascular Delivery System
K190581 · DQY
Abbott Medical
Cardiovascular · 30d
Cleared Apr 05, 2019
CROSSWAY Spinal Access System
K190598 · HRX
Globus Medical, Inc.
Orthopedic · 29d
Cleared Apr 04, 2019
ToxCO
K173238 · CCJ
Bedfont Scientific, Ltd.
Anesthesiology · 546d
Cleared Apr 04, 2019
HIgH-Flo Super26 Subcutaneous Needle Sets
K180843 · FPA
Repro-Med Systems, Inc. Dba Rms...
General Hospital · 367d
Cleared Apr 04, 2019
GMC Upper Arm Automatic Blood Pressure Monitor
K181931 · DXN
Gmc, Inc.
Cardiovascular · 260d
Cleared Apr 04, 2019
FUJIFILM Video Bronchoscopes
K182253 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 227d
Cleared Apr 04, 2019
Park Blade Septostomy Catheter
K182399 · DXF
Cook Incorporated
Cardiovascular · 212d
Cleared Apr 04, 2019
VERTEX Nitinol Staple System
K182943 · JDR
Nvision Biomedical Technologies, LLC
Orthopedic · 163d
Cleared Apr 04, 2019
PYRAMESH™ Implant System
K183197 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 136d
Cleared Apr 04, 2019
Prettau, ICE, Z-White zirconia blanks
K183304 · EIH
Zirkonzahn Srl
Dental · 127d
Cleared Apr 04, 2019
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
K183377 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 119d
Cleared Apr 04, 2019
Erbe APCapplicators
K183445 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 113d
Cleared Apr 04, 2019
CleverLock Guidewire Locking Device and Biopsy Cap
K190164 · ODC
Olympus Surgical Technologies America
Gastroenterology & Urology · 63d
Cleared Apr 04, 2019
Dome Electrode
K190416 · GXY
Coapt, LLC
Neurology · 42d
Cleared Apr 04, 2019
Pixx2430 Digital Diagnostic X-Ray Receptor Panel
K190691 · MQB
Pixxgen Corporation
Radiology · 17d
Cleared Apr 03, 2019
DAEHAN Disposable CUP Electrodes
K180232 · GXY
Daehan Medical Systems Co., Ltd.
Neurology · 429d
Cleared Apr 03, 2019
CONCORDE LIFT
K182349 · MAX
Medos International SARL
Orthopedic · 217d
Cleared Apr 03, 2019
Infrared thermometer
K182597 · FLL
Shenzhen Pango Electronic Co., Ltd.
General Hospital · 195d
Cleared Apr 03, 2019
LINK GEMINI SL Total Knee System
K182872 · JWH
Waldemar Link GmbH & Co. KG
Orthopedic · 173d