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
21361–21384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 2019
T3 Platform software
K190273 · MWI
Etiometry, Inc.
Cardiovascular · 303d
Cleared Dec 07, 2019
PhantomMSK Trauma
K192279 · LLZ
OrthoGrid Systems, Inc.
Radiology · 107d
Cleared CT Dec 06, 2019
ID-Cap System
K183052 · OZW
Etectrx, Inc.
Cardiovascular · 399d
Cleared Dec 06, 2019
Intraocular Pressure Tonometer EASYTON
K190382 · HKX
Company Elamed
Ophthalmic · 290d
Cleared Dec 06, 2019
JJ Implant System
K190552 · DZE
Jj Implants
Dental · 276d
Cleared Dec 06, 2019
EQUINOX Balloon Dilatation Catheter
K190612 · EZN
Dornier Medtech America, Inc.
Gastroenterology & Urology · 270d
Cleared Dec 06, 2019
Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
K190656 · LPH
Zimmer, Inc.
Orthopedic · 267d
Cleared Dec 06, 2019
Smart Peak Flow Meter
K191239 · BZH
Guangzhou Homesun Medical Technology...
Anesthesiology · 212d
Cleared Dec 06, 2019
Disposable SpO2 Sensor
K191279 · DQA
Shenzhen Caremed Medical Technology...
Anesthesiology · 207d
Cleared Dec 06, 2019
Aurora Surgiscope System
K191861 · GWG
Rebound Therapeutics
Neurology · 148d
Cleared Dec 06, 2019
Sheridan Spiral-Flex Endotracheal Tubes
K192324 · BTR
Teleflexmedical, Inc.
Anesthesiology · 101d
Cleared Dec 06, 2019
Dextile Anatomical Mesh
K192443 · FTL
Sofradim Production
General & Plastic Surgery · 91d
Cleared Dec 06, 2019
Intense Pulsed Light Treatment System
K192521 · ONF
Shangdong Huamei Technology Co., Ltd.
General & Plastic Surgery · 84d
Cleared Dec 06, 2019
ALLIVE
K192773 · PCC
Nu Eyne Co., Ltd.
Neurology · 67d
Cleared Dec 06, 2019
Avenir Muller Stem, Avenir Cemented Hip Stem
K193030 · LZO
Zimmer GmbH
Orthopedic · 37d
Cleared Dec 05, 2019
MCI - CMF System
K182758 · JEY
Mci Medical Concept Innovation, Inc.
Dental · 433d
Cleared Dec 05, 2019
G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular...
K190660 · LPH
Zimmer, Inc.
Orthopedic · 266d
Cleared Dec 05, 2019
Neodent Implant System - Temporary Abutments
K191191 · NHA
Jjgc Industria E Comercio DE...
Dental · 216d
Cleared Dec 05, 2019
Southern Implants PEEK Abutments
K191250 · NHA
Southern Implants (Pty), Ltd.
Dental · 210d
Cleared Dec 05, 2019
PICO 14 Single Use Negative Pressure Wound Therapy System
K191760 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 157d
Cleared Dec 05, 2019
TOMi Scope
K191804 · QJG
Photonicare, Inc.
Ear, Nose, Throat · 153d
Cleared Dec 05, 2019
21HK512D
K191864 · PGY
Lg Electronics.Inc
Radiology · 146d
Cleared Dec 05, 2019
Vitra 2
K191962 · GEX
Quantel Medical
Ophthalmic · 135d
Cleared Dec 05, 2019
BC Reflex Uni Knee System
K191996 · HSX
Bodycad Laboratories, Inc.
Orthopedic · 132d