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
29281–29304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 2017
Exactech® Truliant™ Line Extensions
K171045 · JWH
Exactech, Inc.
Orthopedic · 21d
Cleared Apr 27, 2017
Instrument kits
K160730 · KCT
Anthogyr
General Hospital · 407d
Cleared Apr 27, 2017
HAMILTON-C3
K161450 · CBK
Hamilton Medical AG
Anesthesiology · 337d
Cleared Apr 27, 2017
Accessory Irrigation Adapter
K162142 · ODC
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 269d
Cleared Apr 27, 2017
U.S. Laser Worx Patriot 1 family of lasers
K162334 · GEX
U.S. Laser Worx
General & Plastic Surgery · 248d
Cleared Apr 27, 2017
RAPIDEC CARBA NP
K162385 · PTJ
Biomerieux S.A.
Microbiology · 245d
Cleared Apr 27, 2017
Insight Dental System
K170211 · DZE
Insight Dental System
Dental · 93d
Cleared Apr 27, 2017
OneQ-SL s-Clean Implant System
K170220 · DZE
Dentis Co., Ltd.
Dental · 92d
Cleared Apr 27, 2017
Star Tissue Marker
K170905 · NEU
Scion Medical Technologies, LLC
General & Plastic Surgery · 30d
Cleared Apr 27, 2017
RSM 2430C
K170930 · MUE
DRTECH Corporation
Radiology · 29d
Cleared Apr 27, 2017
RadiForce MX315W
K170949 · PGY
Eizo Corporation
Radiology · 27d
Cleared Apr 26, 2017
Pro-Lock CT Safety Infusion Set
K162271 · PTI
Medcomp (Medical Components, Inc.)
General Hospital · 257d
Cleared Apr 26, 2017
Exactech® Alteon® HA Femoral Stem
K162732 · MEH
Exactech, Inc.
Orthopedic · 209d
Cleared Apr 26, 2017
VisualEyes
K163149 · GWN
Interacoustics A/S
Neurology · 168d
Cleared Apr 26, 2017
Apex Revision Knee System
K163332 · JWH
Omnilife Science
Orthopedic · 149d
Cleared Apr 26, 2017
AmCAD-UV
K170069 · LLZ
Amcad Biomed Corporation
Radiology · 107d
Cleared Apr 26, 2017
Restrata Wound Matrix
K170300 · QSZ
Acera Surgical, Inc.
General & Plastic Surgery · 85d
Cleared Apr 26, 2017
Summit Spine Yellowstone Lumbar Interbody Fusion System
K170572 · MAX
Summit Spine
Orthopedic · 58d
Cleared Apr 26, 2017
NuVasive BASE Interfixated Titanium System
K170592 · OVD
Nu Vasive, Incorporated
Orthopedic · 57d
Cleared Apr 26, 2017
HV Screw System
K170889 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 33d
Cleared Apr 26, 2017
CalSet IGF-1
K170938 · JIT
Roche Diagnostics
Chemistry · 27d
Cleared Apr 26, 2017
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
K170942 · NKB
Choicespine, LP
Orthopedic · 27d
Cleared Apr 26, 2017
Zenius Spinal System
K170964 · NKB
Medyssey USA, Inc.
Orthopedic · 26d
Cleared Apr 25, 2017
ET US SS Prosthetic system
K160670 · NHA
Osstem Implant Co., Ltd.
Dental · 411d