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

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175,820 results
30985–31008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 2016
DENTRIa series
K160140 · OAS
Hdx Will Corp.
Radiology · 253d
Cleared Sep 30, 2016
TempoCem Clear
K160443 · EMA
Dmg USA, Inc.
Dental · 226d
Cleared Sep 30, 2016
Atteris Antimicrobial Skin Protectant
K161212 · FRO
Rochal Industries, LLC
General & Plastic Surgery · 155d
Cleared Sep 30, 2016
ON-Q* EchoSpark Echogenic Catheter
K161232 · BSO
Halyard Health
Anesthesiology · 151d
Cleared Sep 30, 2016
Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters
K161464 · NLH
Innovative Health, LLC
Cardiovascular · 127d
Cleared Sep 30, 2016
InterForm Cervical Interbody Cage System
K161608 · ODP
Next Orthosurgical
Orthopedic · 112d
Cleared Sep 30, 2016
i-Sil
K161774 · ELW
Spident Co., Ltd.
Dental · 94d
Cleared Sep 30, 2016
Traxcess .007 Mini Guidewire
K161803 · MOF
MicroVention, Inc.
Neurology · 92d
Cleared Sep 30, 2016
LaserCap300, LaserCap224, LaserCap120, LaserCap80
K161875 · OAP
Transdermal Cap, Inc.
General & Plastic Surgery · 84d
Cleared Sep 30, 2016
Xario 100 Diagnostic Ultrasound System, V5.0
K162187 · IYN
Toshibamedical Systems Corporation
Radiology · 57d
Cleared Sep 30, 2016
8MP Color LCD Monitor (C81W+)
K162527 · PGY
Shenzhen Beacon Display Technology...
Radiology · 21d
Cleared Sep 29, 2016
RENASYS GO
K152163 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 423d
Cleared Sep 29, 2016
WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small...
K160410 · EFB
Dental Savings Club
Dental · 226d
Cleared Sep 29, 2016
CreoDent Solidex Custom Abutment
K160436 · NHA
Creodent Prosthetics, Ltd.
Dental · 225d
Cleared Sep 29, 2016
ELSA Spacers
K161379 · OVD
Globus Medical, Inc.
Orthopedic · 134d
Cleared Sep 29, 2016
Phasix Mesh
K161424 · OOD
C.R. Bard, Inc.
General & Plastic Surgery · 129d
Cleared Sep 29, 2016
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
K161671 · LXB
Oticon Medical AB
Ear, Nose, Throat · 105d
Cleared Sep 29, 2016
SpeediCath Flex Coude
K161672 · GBM
Coloplast Corp.
Gastroenterology & Urology · 112d
Cleared Sep 29, 2016
EZEE RETRIEVAL
K162059 · GCJ
Genicon, Inc.
General & Plastic Surgery · 65d
Cleared Sep 29, 2016
Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac...
K162126 · GEI
ArthroCare Corporation
General & Plastic Surgery · 59d
Cleared Sep 29, 2016
Nexcore GI Insufflator
K162332 · FCX
Nexcore Technology, LLC
Gastroenterology & Urology · 41d
Cleared Sep 29, 2016
IRIDEX Cyclo G6 Laser System, G-Probe Illuminate
K162416 · GEX
Iridex Corporation
General & Plastic Surgery · 30d
Cleared Sep 29, 2016
nva, nvp, and nvt
K162426 · MAX
Nvision Biomedical Technologies, LLC
Orthopedic · 30d
Cleared Sep 28, 2016
PINK CAD/CAM disc
K153546 · EBI
Polident D.O.O., Dental Products...
Dental · 292d