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
19057–19080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 2020
DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking...
K201346 · HSB
Synthes USA Products, LLC
Orthopedic · 125d
Cleared Sep 23, 2020
FlareHawk TiHawk9 Interbody Fusion System
K201367 · MAX
Integrity Implants, Inc.
Orthopedic · 124d
Cleared Sep 23, 2020
IBS Implant System
K202479 · DZE
Innobiosurg Co., Ltd.
Dental · 26d
Cleared Sep 23, 2020
Responsive Arthroscopy Interference Screw System
K202569 · HWC
Responsive Arthroscopy, LLC
Orthopedic · 19d
Cleared Sep 22, 2020
Accessories for the SixFix® Hexapod Fixator
K200123 · KTT
Arrowhead De, LLC
Orthopedic · 245d
Cleared Sep 22, 2020
Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with...
K200843 · LZA
O&M Halyard, Inc.
General Hospital · 175d
Cleared Sep 22, 2020
LTJ Screws and Washer
K200987 · HWC
Azurmeds, Inc.
Orthopedic · 160d
Cleared Sep 22, 2020
BD Cathena Safety IV Catheter
K201717 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 91d
Cleared Sep 22, 2020
Vantage Orian 1.5T, MRT-1550, V6.0
K202210 · LNH
Canon Medical Systems Corporation
Radiology · 47d
Cleared Sep 22, 2020
DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
K202448 · MVN
Alcon Laboratories, Inc.
Ophthalmic · 27d
Cleared Sep 21, 2020
Optiflux F180NR Dialyzer
K192707 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 360d
Cleared Sep 21, 2020
Pounce Thrombus Retrieval System
K192814 · QEW
Surmodics,Inc.
Cardiovascular · 356d
Cleared Sep 21, 2020
World Hip Stem, World Cup, World Liner
K201278 · MEH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 131d
Cleared Sep 21, 2020
Medline DeNovo 4Pro Electrical Stimulation Device
K201290 · IPF
Medline Industries, Inc.
Physical Medicine · 130d
Cleared Sep 21, 2020
Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B
K201467 · DXN
Bioland Technology, Ltd.
Cardiovascular · 111d
Cleared Sep 20, 2020
AAA Model
K200603 · LLZ
Philips Ultrasound, Inc.
Radiology · 195d
Cleared Sep 20, 2020
CORVUS
K201350 · MUJ
Best Nomos
Radiology · 122d
Cleared Sep 19, 2020
B&J DVT Calf/Thigh Garments, Models 801/830 Series
K201532 · JOW
B&J Manufacturing , Ltd.
Cardiovascular · 103d
Cleared Sep 18, 2020
LaborView™ LV1000 Wireless Electrode System
K190798 · OSP
Obmedical Company
Obstetrics & Gynecology · 540d
Cleared Sep 18, 2020
Intellifuse Administration and Intellifuse Blood Administration Sets
K192375 · FPA
Smiths Medical Asd, Inc.
General Hospital · 385d
Cleared Sep 18, 2020
DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
K192702 · GXN
Synthes USA Products, LLC
Neurology · 357d
Cleared Sep 18, 2020
SentEP
K192890 · LLZ
Sentiar, Inc.
Cardiovascular · 344d
Cleared Sep 18, 2020
Smart Correction System
K193368 · KTT
Wishbone Medical, Inc.
Orthopedic · 288d
Cleared Sep 18, 2020
DIA-ROOT BIO MTA
K200174 · KIF
DiaDent Group International
Dental · 239d