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
44713–44736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 2012
MULTI-MODALITY IMAGE FUSION
K120187 · LLZ
Igt, LLC Dba Eigen
Radiology · 74d
Cleared Apr 06, 2012
NANOFUSE DBM
K120279 · MQV
Nanotherapeutics
Orthopedic · 67d
Cleared Apr 06, 2012
SYNAPSE 3D BASE TOOLS
K120361 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 60d
Cleared Apr 06, 2012
RAYSTATION
K120387 · MUJ
Raysearch Laboratories AB
Radiology · 59d
Cleared Apr 06, 2012
INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
K120388 · OXO
Hologic, Inc.
Radiology · 59d
Cleared Apr 06, 2012
MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM,...
K120448 · CGA
Apex BioTechnology Corp.
Chemistry · 52d
Cleared Apr 06, 2012
OEC 9900 ELITE
K120613 · OXO
Ge Healthcare Surgery GE Oec Medical...
Radiology · 37d
Cleared Apr 06, 2012
THE DOME GX4MP COLOR NONITOR
K120709 · LLZ
Nds Surgical Imaging
Radiology · 29d
Cleared Apr 06, 2012
AQUILION PRIME
K120710 · JAK
Toshibamedical Systems Corporation
Radiology · 29d
Cleared Apr 06, 2012
EOS
K120721 · MQB
Eos Imaging
Radiology · 29d
Cleared Apr 05, 2012
TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM,...
K110481 · EIA
Asi Medical, Inc.
Dental · 412d
Cleared Apr 05, 2012
STEAM DOT BLU PROCESS INDICATOR
K111453 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 316d
Cleared Apr 05, 2012
2GC HIP/KNEE MODULAR SPACER
K112470 · KWL
Mandell Horwitz Consultants, LLC
Orthopedic · 223d
Cleared Apr 05, 2012
ADVANTAGE LASER SYSTEM
K113502 · GEX
Lutronic Corporation
General & Plastic Surgery · 132d
Cleared Apr 05, 2012
CMI IMPLANT IS SYSTEM
K113554 · DZE
Neobiotech Co., Ltd.
Dental · 126d
Cleared Apr 05, 2012
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY...
K113626 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 119d
Cleared Apr 05, 2012
STELLAR 150
K113640 · MNT
Resmed Germany, Inc.
Anesthesiology · 118d
Cleared Apr 05, 2012
SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER &...
K113674 · EFB
Handpiece Headquarters, Inc. - Hpr, Inc.
Dental · 113d
Cleared Apr 05, 2012
GRINDCARE MEASURE
K113677 · KZM
Medotech A/S
Dental · 113d
Cleared Apr 05, 2012
NUCAL
K120003 · EJK
Pulpdent Corporation
Dental · 93d
Cleared Apr 05, 2012
CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM
K120570 · MQP
Choicespine, LP
Orthopedic · 38d
Cleared Apr 05, 2012
EAGLE EYE PLATINUM ST CATHETER
K120697 · OBJ
Volcano Corporation
Radiology · 29d
Cleared Apr 05, 2012
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5...
K120828 · FRO
Coloplast A/S
General & Plastic Surgery · 17d
Cleared Apr 04, 2012
JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 /...
K111274 · OCX
Jetprep, Ltd.
Gastroenterology & Urology · 335d