Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
33841–33864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 2015
SterilContainer S
K151242 · KCT
Aesculap, Inc.
General Hospital · 151d
Cleared Oct 09, 2015
Amia Automated PD System with Sharesource
K151525 · FKX
Deka Research and Development
Gastroenterology & Urology · 123d
Cleared Oct 09, 2015
Powder Free Nitrile (Black) Examination Gloves
K151528 · LZA
Gallant Quality Sdn. Bhd.
General Hospital · 123d
Cleared Oct 09, 2015
G-Fix
K151541 · EBF
GC America, Inc.
Dental · 123d
Cleared Oct 09, 2015
Endoskeleton TCS Interbody Fusion Device
K151596 · OVE
Titan Spine, LLC
Orthopedic · 119d
Cleared Oct 09, 2015
Dr-Ho's Foot Pad Electrode
K151693 · GXY
Drtv Asia, Ltd.
Neurology · 108d
Cleared Oct 09, 2015
REVE134
K151719 · KLW
Kw Ear Lab, Inc.
Ear, Nose, Throat · 106d
Cleared Oct 09, 2015
Dyevert Contrast Modulation System
K151746 · DXT
Osprey Medical, Inc.
Cardiovascular · 102d
Cleared Oct 09, 2015
Aquilion Lightning (TSX-035A/2, V7.0)
K151833 · JAK
Toshibamedical Systems Corporation
Radiology · 95d
Cleared Oct 09, 2015
SOMATOM Definition Edge, SOMATOM Definition AS/AS+
K152036 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Oct 09, 2015
Auto Suture Locking Trocar
K152565 · GCJ
Covidien
General & Plastic Surgery · 30d
Cleared Oct 08, 2015
WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT
K134036 · GEI
Loktal Medical Electronics Ind. Com....
General & Plastic Surgery · 646d
Cleared Oct 08, 2015
Single Use Balloon Dilator V (with Knife)
K150142 · KNS
Olympus Medical Systems Corp.
Gastroenterology & Urology · 259d
Cleared Oct 08, 2015
X-Guide Surgical Navigation System
K150222 · PLV
X-Nav Technologies, LLC
Dental · 251d
Cleared Oct 08, 2015
Podimetrics Remote Temperature Monitoring System
K150557 · OIZ
Podimetrics,Inc.
General Hospital · 218d
Cleared Oct 08, 2015
Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)
K150669 · NHA
Neoss, Ltd.
Dental · 206d
Cleared Oct 08, 2015
Salem Sump Dual Lumen Stomach Tube with Multi-functional Port
K150711 · PIF
Covidien
Gastroenterology & Urology · 203d
Cleared Oct 08, 2015
OsteoReady ZircoSeal Abutments
K151169 · NHA
Osteoready, LLC
Dental · 160d
Cleared Oct 08, 2015
CONCORDE Bullet Spinal System
K151352 · MAX
Medos International SARL
Orthopedic · 141d
Cleared Oct 08, 2015
PRETTAU ANTERIOR T0
K151490 · EIH
Zirkonzahn GmbH
Dental · 127d
Cleared Oct 08, 2015
AttraX Putty
K151584 · MQV
Progentix Orthobiology BV
Orthopedic · 119d
Cleared Oct 08, 2015
Passeo-18 Peripheral Dilation Catheter
K151744 · LIT
Biotronik, Inc.
Cardiovascular · 101d
Cleared Oct 08, 2015
STERISPINE PS
K151921 · NKB
Safe Orthopaedics
Orthopedic · 87d
Cleared Oct 08, 2015
Passeo-14 Peripheral Dilatation Catheter
K152240 · LIT
Biotronik, Inc.
Cardiovascular · 59d