FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
8857–8880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 20, 2023
BioShield Biopsy Valve (00711124)
K232951 · ODC
Steris
Gastroenterology & Urology · 29d
Cleared Oct 20, 2023
Pure-Vu EVS System
K232922 · FDF
Motus GI Medical Technologies , Ltd.
Gastroenterology & Urology · 31d
Cleared Oct 20, 2023
TuxDeluxe (Size 1 6100B, Size 2 6101B)
K232552 · MUH
Tuxedo Imaging, LLC
Radiology · 58d
Cleared Oct 20, 2023
Nitrile Examination Gloves, Dual Color Black-Blue
K232550 · LZA
Shanxi Hongjin Plastic Technology...
General Hospital · 58d
Cleared Oct 20, 2023
Echo
K232236 · GEX
Quanta System Spa
General & Plastic Surgery · 85d
Cleared Oct 20, 2023
NexPort™ Trocar System (TS211001)
K232042 · GCJ
Mediconcepts Technology (Shenzhen)...
General & Plastic Surgery · 102d
Cleared Oct 20, 2023
GAMMEX PI Hybrid Micro (340002055)
K231902 · KGO
Ansell Healthcare
General Hospital · 114d
Cleared Oct 20, 2023
Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
K231809 · PML
Ulrich Medical USA
Orthopedic · 122d
Cleared Oct 20, 2023
Lucitone Digital Print Denture System
K231578 · EBI
Dentsply Sirona
Dental · 142d
Cleared Oct 20, 2023
NextDent Base
K231388 · EBI
Vertex-Dental B.V.
Dental · 161d
Cleared Oct 20, 2023
Digital Wireless Intraoral X-Ray Sensor
K230998 · MUH
Iray Imaging Technology (Haining)...
Radiology · 196d
Cleared Oct 20, 2023
Unicare (K-UNICARE-USA)
K230983 · KPI
Tenscare, Ltd.
Gastroenterology & Urology · 197d
Cleared Oct 20, 2023
Sonix Health
K230209 · QIH
Ontact Health Co., Ltd.
Radiology · 268d