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
21001–21024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 2020
EEA Circular Stapler with Tri-Staple Technology
K192330 · GDW
Covidien
General & Plastic Surgery · 149d
Cleared Jan 23, 2020
Bactisure Wound Lavage
K192349 · FQH
Next Science, LLC
General & Plastic Surgery · 147d
Cleared Jan 23, 2020
Healing Abutments and Cover Screws
K192436 · NHA
Dentium Co., Ltd.
Dental · 139d
Cleared Jan 23, 2020
Surefil one Self-adhesive Composite Hybrid
K192530 · EMA
Dentsply Sirona
Dental · 129d
Cleared Jan 23, 2020
Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor
K193295 · MBI
Parcus Medical, LLC
Orthopedic · 57d
Cleared Jan 23, 2020
HardyDisk AST Cefiderocol 30ug (FDC30)
K193504 · JTN
Hardy Diagnostics
Microbiology · 36d
Cleared Jan 22, 2020
Internal Hex Implant System
K190837 · DZE
Ebi, Inc.
Dental · 296d
Cleared Jan 22, 2020
Fundus Camera
K190954 · HKI
Chongqing Bio Newvision Medical...
Ophthalmic · 286d
Cleared Jan 22, 2020
Isopure Dry Acid Dissolution System
K191093 · KPO
Isopure, Corp.
Gastroenterology & Urology · 272d
Cleared Jan 22, 2020
Spectra Q
K191109 · HGX
Uzinmedicare Co.
Obstetrics & Gynecology · 271d
Cleared Jan 22, 2020
E-EEGX, N-EEGX
K191322 · OLT
GE Healthcare Finland Oy
Neurology · 252d
Cleared Jan 22, 2020
FastFit EMS System
K192161 · NGX
Fast Fit, LLC
Physical Medicine · 166d
Cleared Jan 22, 2020
Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion...
K192502 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 132d
Cleared Jan 22, 2020
HydroPearl Microspheres
K192684 · NOY
MicroVention, Inc.
Gastroenterology & Urology · 118d
Cleared Jan 22, 2020
SCARLET AL-T
K192993 · OVD
Spineart
Orthopedic · 89d
Cleared Jan 22, 2020
Q-Rad System
K193574 · KPR
Carestream Health, Inc.
Radiology · 30d
Cleared Jan 22, 2020
Y-Knot OneStep Anchor
K193606 · MBI
Conmed Corporation
Orthopedic · 30d
Cleared Jan 21, 2020
CARESCAPE B650
K191149 · MHX
GE Healthcare Finland Oy
Cardiovascular · 266d
Cleared Jan 21, 2020
TrapIt
K191229 · DQY
Imds Operations B.V.
Cardiovascular · 258d
Cleared Jan 21, 2020
Hydro-Temp Neonatal Skin Temperature Probe Cover
K191425 · FMT
Deroyal Industries, Inc.
General Hospital · 237d
Cleared Jan 21, 2020
Disposable Gold Cup EEG Electrodes
K192564 · GXY
Dymedix Diagnostics, Inc.
Neurology · 125d
Cleared Jan 21, 2020
Medline Glide-On 3G Vinyl Examination Gloves
K192985 · LYZ
Medline Industries, Inc.
General Hospital · 88d
Cleared Jan 21, 2020
Nexxt Matrixx System
K193370 · MAX
Nexxt Spine, LLC
Orthopedic · 47d
Cleared Jan 21, 2020
ZELTIQ CoolSculpting System
K193566 · OOK
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 29d