FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
8569–8592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2023
Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360...
K232584 · OWQ
Vein 360, LLC
Cardiovascular · 60d
Cleared Oct 24, 2023
Steerant™ Super Stiff Guidewire
K232570 · DQX
Medtronic Vascular
Cardiovascular · 61d
Cleared Oct 24, 2023
Laser Cap, Model: Hat-01
K232356 · OAP
Hubei Yjt Technology Co.,Ltd
General & Plastic Surgery · 78d
Cleared Oct 24, 2023
PlaDuo System
K232223 · GEI
ShenB Co., Ltd.
General & Plastic Surgery · 90d
Cleared Oct 24, 2023
REUNION Sacroiliac Joint Fusion System
K232211 · OUR
Astura Medical
Orthopedic · 90d
Cleared Oct 24, 2023
spineEOS
K232086 · LLZ
Eos Imaging
Radiology · 103d
Cleared Oct 24, 2023
VISULAS green
K232051 · HQF
Carl Zeiss Meditec
Ophthalmic · 106d
Cleared Oct 24, 2023
Aco Apache Ultrasound System
K231509 · IYN
Aco Healthcare Co., Ltd.
Radiology · 152d
Cleared Oct 24, 2023
Acumen IQ finger cuff
K230919 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 204d
Cleared Oct 24, 2023
Sonopuls 190
K230472 · IMI
Enraf-Nonius, B.V.
Physical Medicine · 244d
Cleared Oct 23, 2023
Shadow Knotless All-Suture Anchors
K233258 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 25d
Cleared Oct 23, 2023
Ripley Spinal Screw System by SAGICO
K232561 · NKB
Sagico VA USA, LLC
Orthopedic · 60d
Cleared Oct 23, 2023
AI-Rad Companion Brain MR
K232305 · QIH
Siemens Medical Solutions U.S.A.
Radiology · 83d
Cleared Oct 23, 2023
Vesco Q™ Enteral Feeding Pump
K232205 · LZH
Vesco Medical, LLC
General Hospital · 90d
Cleared Oct 23, 2023
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2...
K232201 · LON
bioMerieux, Inc.
Microbiology · 90d
Cleared Oct 23, 2023
Applanation Tonometer HT-5000
K232143 · HKY
Huvitz Co., Ltd.
Ophthalmic · 96d
Cleared Oct 23, 2023
Ultrasound System 1300
K231764 · IYN
Bk Medical Aps
Radiology · 129d
Cleared Oct 23, 2023
CleanSeal Advanced Bipolar Vessel Sealer Maryland
K231732 · GEI
Conmed Corporation
General & Plastic Surgery · 132d
Cleared Oct 23, 2023
MAGNETOM Vida
K231560 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 146d
Cleared Oct 23, 2023
Swiss LthoClast Trilogy
K230893 · FEO
E.M.S Electro Medical Systems S.A
Gastroenterology & Urology · 206d
Cleared Oct 23, 2023
PICOCLAMP
K230281 · DXC
Kono Seisakusho Co., Ltd.
Cardiovascular · 264d
Cleared Oct 22, 2023
JO Coconut Hybrid Cooling Personal Lubricant
K232091 · NUC
CC Wellness, LLC
Obstetrics & Gynecology · 101d
Cleared Oct 21, 2023
pRESET LITE Thrombectomy Device
K231539 · POL
Phenox Limited
Neurology · 144d
Cleared Oct 20, 2023
V-PRO maX 2 Low Temperature Sterilization System
K233065 · MLR
Steris
General Hospital · 24d