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
30505–30528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 2016
Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse...
K161162 · GEX
Ellipse A/S
General & Plastic Surgery · 144d
Cleared Sep 16, 2016
Syntorr K-wire and Pin System
K161489 · HTY
Syntorr, Inc.
Orthopedic · 107d
Cleared Sep 16, 2016
Bone Solutions Mixing and Delivery System
K161568 · FMF
Bone Solutions, Inc.
General Hospital · 101d
Cleared Sep 16, 2016
LigaSure Retractable L-Hook Laparoscopic Sealer/Divider
K161804 · GEI
Covidien
General & Plastic Surgery · 78d
Cleared Sep 16, 2016
DoseCHECK
K161946 · IYE
Sun Nuclear Corporation
Radiology · 63d
Cleared Sep 16, 2016
JiveX
K162008 · LLZ
Visus Technology Transfer GmbH
Radiology · 58d
Cleared Sep 16, 2016
TRILLIUM Oval Head Coil 32
K162079 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 51d
Cleared Sep 16, 2016
mi-eye 2, mi-eye 2 monitor
K162475 · HRX
Trice Medical
Orthopedic · 10d
Cleared Sep 15, 2016
KBL Sunlamp Products (= Device Bundling name)
K151962 · LEJ
Kbl AG
General & Plastic Surgery · 427d
Cleared Sep 15, 2016
Luminesse Shaded Zirconia SZ
K152023 · EIH
Talladium, Inc.
Dental · 422d
Cleared Sep 15, 2016
TEMPEDY
K152946 · NCX
Seiratherm GmbH
Neurology · 345d
Cleared Sep 15, 2016
PROW FUSION-L
K153665 · MAX
Nlt Spine, Ltd.
Orthopedic · 269d
Cleared Sep 15, 2016
HBOTC Muscle and Nerve Stimulator
K160255 · NUH
Hb Medical, Inc.
Neurology · 227d
Cleared Sep 15, 2016
Pledgeted COR-SUTURE QUICK LOAD
K160529 · GAW
Lsi Soultions
General & Plastic Surgery · 203d
Cleared Sep 15, 2016
Dentium Implantium & SuperLine Prosthetics
K160828 · NHA
Dentium Co., Ltd.
Dental · 174d
Cleared Sep 15, 2016
Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”,...
K161067 · QSZ
Engineered Tissue Solutions, LLC
General & Plastic Surgery · 153d
Cleared Sep 15, 2016
Compound W Wart Removal System Dual Power
K161294 · GEH
Medtech Products, Inc.
General & Plastic Surgery · 129d
Cleared Sep 15, 2016
Provicol QM Plus
K161630 · EMB
Voco GmbH
Dental · 94d
Cleared Sep 15, 2016
CARESCAPE Central Station V2
K162012 · DXJ
Ge Healthcare
Cardiovascular · 56d
Cleared Sep 15, 2016
Eusol-C
K162013 · LYX
Al.Chi.Mi.A. S.R.L
Ophthalmic · 56d
Cleared Sep 15, 2016
LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated
K162047 · GEI
Covidien
General & Plastic Surgery · 52d
Cleared Sep 15, 2016
PhotonBlade
K162053 · GEI
Invuity, Inc.
General & Plastic Surgery · 52d
Cleared Sep 15, 2016
CORGRIP NG/NI Tube Retention System
K162110 · KNT
Corpak Medsystems, Inc. A Division of...
Gastroenterology & Urology · 48d
Cleared Sep 14, 2016
Flexitouch System
K153311 · PPS
Tactile Systems Technology, Inc. (Dba...
Cardiovascular · 302d