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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
71425–71448 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 2003
EXCISOR BIOPTOME, MODEL 01-0004
K032847 · KNW
Acueity, Inc.
Gastroenterology & Urology · 14d
Cleared Sep 26, 2003
ULTRACROWN 75 ALLOY
K032851 · EJT
Dentsply International
Dental · 14d
Cleared Sep 26, 2003
MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM
K032892 · EBI
Dentsply Intl.
Dental · 9d
Cleared Sep 25, 2003
OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER
K030393 · MXK
Haag-Streit Holding AG
Ophthalmic · 232d
Cleared Sep 25, 2003
RINSPIRATION SYSTEM
K031485 · DQO
Kerberos Proximal Solutions
Cardiovascular · 136d
Cleared Sep 25, 2003
SENTINOL NITINOL BILLARY STENT SYSTEM
K032025 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Sep 25, 2003
BLINK CL LUBRICANT EYE DROPS
K032030 · LPN
Advanced Medical Optics, Inc.
Ophthalmic · 86d
Cleared Sep 25, 2003
RATTAN IMACS BY RATTAN INFORMATION CORPORATION
K032176 · LLZ
Rattan Information Corporation
Radiology · 71d
Cleared Sep 25, 2003
PRECISE CARBON FIBER TABLE TOP, MODEL 11-999
K032248 · IYE
Aktina Medical Physics Corp.
Radiology · 65d
Cleared Sep 25, 2003
ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105...
K032355 · EHD
Dentsply Gendex
Radiology · 57d
Cleared Sep 25, 2003
SAPPHIRE VDS TENSION SAFE DETACHABLE COIL, E-3-12/3-T10-VT
K032497 · HCG
Micro Therapeutics, Inc.
Neurology · 43d
Cleared Sep 25, 2003
EXOMIO, MODEL 2.0 SP1
K032550 · KPQ
Medcom GmbH
Radiology · 38d
Cleared Sep 25, 2003
NUMED TYSHAK MINI PEDIATRIC PTV CATHETER
K032591 · DQY
NuMED, Inc.
Cardiovascular · 34d
Cleared Sep 25, 2003
HRK-63-8 KNEE ARRAY COIL
K032633 · MOS
Mri Devices Corp.
Radiology · 30d
Cleared Sep 24, 2003
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K030187 · NLH
Alliance Medical, Inc.
Cardiovascular · 246d
Cleared Sep 24, 2003
HEMAPROMPT GASTRIC
K031356 · KHE
Aerscher Diagnostics
Hematology · 166d
Cleared Sep 24, 2003
GI SUPPLY BILIARY STENT
K031360 · FGE
Gi Supply
Gastroenterology & Urology · 147d
Cleared Sep 24, 2003
EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
K031898 · GKR
Ekf Diagnostic GmbH
Hematology · 97d
Cleared Sep 24, 2003
GLOBAL CAP RESURFACING REPLACEMENT SHOULDER
K031971 · HSD
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Sep 24, 2003
TELEMIS-MEDICAL SOLUTION
K032157 · LLZ
Telemis S.A.
Radiology · 72d
Cleared Sep 24, 2003
JUSTWIN SCOOTER, MODEL JS-401
K032277 · INI
Joy Ride Tech Co., Ltd.
Physical Medicine · 63d
Cleared Sep 24, 2003
RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T,
K032402 · IOR
Convaid Products, Inc.
Physical Medicine · 51d
Cleared Sep 24, 2003
WU'S 4-WHEELED NEO SCOOTER, WT-M4JR
K032489 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 43d
Cleared Sep 24, 2003
AIR PRESS MASSAGER
K032505 · IRP
Telebrands Corp
Physical Medicine · 42d