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
20257–20280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 2020
Rio Vial-to-Bag Drug Reconstitution Device
K192154 · LHI
Icu Medical
General Hospital · 255d
Cleared Apr 20, 2020
CapKlenZ
K192382 · QBP
Star Mountain Medical, Inc.
General Hospital · 234d
Cleared Apr 20, 2020
KY Grosz Liquid
K193032 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 172d
Cleared Apr 20, 2020
QuickClear Mechanical Thrombectomy System
K193197 · QEZ
Volcano Atheromed, Inc.
Cardiovascular · 152d
Cleared Apr 20, 2020
Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit,...
K193343 · DRG
Vitalconnect, Inc.
Cardiovascular · 139d
Cleared Apr 20, 2020
uMR 570
K200024 · LNH
Shanghai United Imaging Healthcare...
Radiology · 105d
Cleared Apr 20, 2020
MOTO PFJ System
K200122 · KRR
Medacta International S.A.
Orthopedic · 90d
Cleared Apr 20, 2020
CarpX
K200559 · GEI
Pavmed, Inc.
General & Plastic Surgery · 48d
Cleared Apr 20, 2020
Sentinel
K200600 · IYE
C-Rad Positioning AB
Radiology · 42d
Cleared Apr 18, 2020
S4 Screw System
K191995 · HWC
Subchondral Solutions, Inc.
Orthopedic · 267d
Cleared Apr 18, 2020
Route 92 Medical 088 Access System, 110 cm
K200121 · QJP
Route 92 Medical, Inc.
Neurology · 88d
Cleared Apr 17, 2020
BRUIS Software Suite
K191720 · PNN
Mechanodontics, Inc.
Dental · 295d
Cleared Apr 17, 2020
Irradiation Cosmetic Device
K192552 · OAP
Chongqing Peninsula Medical...
General & Plastic Surgery · 213d
Cleared Apr 17, 2020
Diode Laser Therapy Device
K200118 · GEX
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 87d
Cleared Apr 17, 2020
LOGIQ E10
K200158 · IYN
GE Medical Systems Ultrasound &...
Radiology · 86d
Cleared Apr 17, 2020
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex...
K200257 · MQR
Boston Scientific Corporation
Gastroenterology & Urology · 74d
Cleared Apr 17, 2020
ProLift Lateral Fixated
K200338 · OVD
Life Spine, Inc.
Orthopedic · 66d
Cleared Apr 17, 2020
Kyocera Bipolar Hip System
K200709 · KWY
Kyocera Medical Technologies, Inc.
Orthopedic · 30d
Cleared Apr 17, 2020
Rumble Tuff Electric Breast Pump
K200712 · HGX
A Cute Baby, Inc.
Obstetrics & Gynecology · 30d
Cleared Apr 17, 2020
Opticross 35 15 MHz Peripheral Imaging Catheter
K200733 · ITX
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Apr 17, 2020
SI-Restore Sacroiliac Joint Fixation System
K200868 · OUR
Biofusion Medical
Orthopedic · 16d
Cleared Apr 16, 2020
Philips Biosensor BX100
K192875 · DRG
Philips Medical Systems
Cardiovascular · 191d
Cleared Apr 16, 2020
Unicel DxH 800 Coulter Cellular Analysis System
K193124 · GKZ
Beckman Coulter
Hematology · 156d
Cleared Apr 16, 2020
ARTIS Icono
K193326 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 136d