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
30553–30576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 2016
Liberator Powered Wheelchair with Solar Companion
K153636 · ITI
Solar Mobilityllc
Physical Medicine · 266d
Cleared Sep 09, 2016
ULYSS Multi View Sinuscope
K153701 · EOB
Sopro-Comeg GmbH
Ear, Nose, Throat · 261d
Cleared Sep 09, 2016
AbClose - Port Site Closure Device
K160117 · OCW
Medeon Biodesign, Inc.
General & Plastic Surgery · 234d
Cleared Sep 09, 2016
Enseal X1 Large Jaw Tissue Sealer
K160554 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 193d
Cleared Sep 09, 2016
Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)
K160754 · GEI
Venclose, Inc.
General & Plastic Surgery · 175d
Cleared Sep 09, 2016
S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV
K160822 · BZD
Resmed, Ltd.
Anesthesiology · 169d
Cleared Sep 09, 2016
Self-retaining Retractor
K161004 · GZT
Fetzer Medical GmbH & Co. KG
Neurology · 151d
Cleared Sep 09, 2016
All-Bond Universal w/BAC (not finalized)
K161051 · KLE
Bisco, Inc.
Dental · 148d
Cleared Sep 09, 2016
EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with...
K161187 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 135d
Cleared Sep 09, 2016
ClearRead CT
K161201 · OEB
Riverain Technologies, LLC
Radiology · 134d
Cleared Sep 09, 2016
Matrix LS-40 CO2 Laser System
K161356 · GEX
Shanghai Wonderful Opto-Electrics...
General & Plastic Surgery · 116d
Cleared Sep 09, 2016
VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
K161487 · MNS
Resmed, Ltd.
Anesthesiology · 101d
Cleared Sep 09, 2016
Arthrex Synergy RF System
K161581 · GEI
Arthrex, Inc.
General & Plastic Surgery · 93d
Cleared Sep 09, 2016
Tritium® Sternal Cable Plate System
K161876 · JDQ
Pioneer Surgical Technology, Inc....
Orthopedic · 63d
Cleared Sep 09, 2016
Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe...
K161915 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 59d
Cleared Sep 09, 2016
TorqVue Low Profile Delivery Catheter
K162228 · DQY
Aga Medical Corporation (Wholly Owned...
Cardiovascular · 32d
Cleared Sep 08, 2016
BBX1, BBX2, BBX1MO, BBX1MC
K142846 · DZE
Globaldental, Inc.
Dental · 709d
Cleared Sep 08, 2016
coflex-IF
K153302 · PEK
Paradigm Spine, LLC
Orthopedic · 300d
Cleared Sep 08, 2016
Luna CPAP and Auto CPAP System
K153387 · BZD
3B Medical, Inc.
Anesthesiology · 290d
Cleared Sep 08, 2016
RTS Flexible 1 MPJ Implant w/Grommets
K153609 · KWH
In2bones USA, LLC
Orthopedic · 266d
Cleared Sep 08, 2016
Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable...
K160493 · NPK
Salvin Dental Specialties
Dental · 199d
Cleared Sep 08, 2016
Battalion Universal Spacer System
K160958 · PHM
Alphatec Spine
Orthopedic · 156d
Cleared Sep 08, 2016
PILLAR SA PTC
K161129 · OVD
Orthofix, Inc.
Orthopedic · 140d
Cleared Sep 08, 2016
StageOne Select Cement Spacer Molds for Temporary Hip Replacement
K161166 · MBB
Biomet, Inc.
Orthopedic · 135d