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
31945–31968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2016
Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical...
K153131 · MEH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 217d
Cleared Jun 03, 2016
LunulaLaser
K153164 · PDZ
Erchonia Medical, Inc.
General & Plastic Surgery · 214d
Cleared Jun 03, 2016
Medipure Oxygen-LC System
K153518 · ECX
Praxair Distribution, Incorporated.
Anesthesiology · 178d
Cleared Jun 03, 2016
Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture...
K153611 · GAM
Ethicon, LLC
General & Plastic Surgery · 169d
Cleared Jun 03, 2016
Strive
K153704 · GZJ
Djo, LLC
Neurology · 163d
Cleared Jun 03, 2016
LifeStream Management System, LifeStream Management Suite, LifeStream Patient...
K153719 · DRG
Honeywell Hommed, LLC
Cardiovascular · 158d
Cleared Jun 03, 2016
Heat Pain Pro
K160115 · NUH
Omron Healthcare, Inc.
Neurology · 136d
Cleared Jun 03, 2016
dynaMX(TM) Nitinol Compression Screw
K160427 · HWC
Mx Orthopedics, Corp.
Orthopedic · 108d
Cleared Jun 03, 2016
Large Screws Range
K160617 · HWC
Newclip Technics
Orthopedic · 92d
Cleared Jun 03, 2016
iFUSE Implant System
K160652 · OUR
SI-BONE, Inc.
Orthopedic · 87d
Cleared Jun 03, 2016
OrthoButton CL
K160655 · MBI
Riverpoint Medical
Orthopedic · 87d
Cleared Jun 03, 2016
HumaPen Savvio
K160668 · FMF
Eli Lilly and Company, Inc.
General Hospital · 86d
Cleared Jun 03, 2016
Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
K160775 · NKB
Choicespine, LP
Orthopedic · 74d
Cleared Jun 03, 2016
Sonendo GentleWave System
K160905 · ELC
Sonendo, Inc.
Dental · 63d
Cleared Jun 03, 2016
Halo One Thin-Walled Guiding Sheath
K161183 · DYB
C.R. Bard, Inc.
Cardiovascular · 37d
Cleared Jun 02, 2016
ABC D-FLEX PROBE
K151229 · GEI
Conmed Corporation
General & Plastic Surgery · 392d
Cleared Jun 02, 2016
MTR550 (Tentative) Antimicrobial Silver Wound Gel
K152519 · FRO
Medical Technology Research, Inc.
General & Plastic Surgery · 273d
Cleared Jun 02, 2016
Anker II Dental Implant System
K152576 · DZE
Alliance Global Technology Co., Ltd.
Dental · 267d
Cleared Jun 02, 2016
Helios III
K152856 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 247d
Cleared Jun 02, 2016
Gun Oil, Pink, Gun Oil H2O, Pink Water
K152918 · NUC
Empowered Products, Inc.
Obstetrics & Gynecology · 244d
Cleared Jun 02, 2016
NobelDesign Software
K153036 · NHA
Nobel Biocare AB
Dental · 227d
Cleared Jun 02, 2016
PowerGlide Pro Midline Catheter
K153280 · FOZ
C.R. Bard, Inc.
General Hospital · 203d
Cleared Jun 02, 2016
LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head,...
K153606 · GCJ
Smith & Nephew
General & Plastic Surgery · 168d
Cleared Jun 02, 2016
O-pel Laser and families of probe delivery devices
K160012 · GEX
Precise Light Surgical
General & Plastic Surgery · 150d