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
55513–55536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 2008
MINI GHOST, MODEL: 507
K082524 · DQY
NuMED, Inc.
Cardiovascular · 24d
Cleared Sep 26, 2008
HASELMEIER PEN 8
K082616 · FMF
Haselmeier GmbH
General Hospital · 17d
Cleared Sep 26, 2008
GALAXY 55
K082685 · MWI
Larsen & Toubro Limited
Cardiovascular · 11d
Cleared Sep 25, 2008
CHOOSTENT
K072094 · ESW
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 423d
Cleared Sep 25, 2008
ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT
K080164 · NHA
Zimmer Dental, Inc.
Dental · 246d
Cleared Sep 25, 2008
AUDICOR SENSOR, MODELS: 2.0, 3.0
K080602 · DRX
Inovise Medical, Inc.
Cardiovascular · 206d
Cleared Sep 25, 2008
K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME
K081236 · NUC
Mcneil-Ppc, Inc.
Obstetrics & Gynecology · 147d
Cleared Sep 25, 2008
MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90)
K081386 · IYN
Esaote, S.P.A.
Radiology · 129d
Cleared Sep 25, 2008
L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS &...
K081489 · HCH
Peter Lazic GmbH
Neurology · 120d
Cleared Sep 25, 2008
AED MONOPOLAR LAP ACCESSORIES
K081503 · GEI
National Advanced Endoscopy Devices,...
General & Plastic Surgery · 119d
Cleared Sep 25, 2008
MODIFICATION TO HAMILTON-G5
K081521 · CBK
Hamilton Medical AG
Anesthesiology · 118d
Cleared Sep 25, 2008
BISQUE ZIRCONIA BLANKS, TYPE BYZ
K081850 · EIH
Zircar Zirconia, Inc.
Dental · 87d
Cleared Sep 25, 2008
PROLONG
K081864 · BSP
Life-Tech, Inc.
Anesthesiology · 86d
Cleared Sep 25, 2008
AW SERVER
K081985 · LLZ
Ge Medical Systems, LLC
Radiology · 73d
Cleared Sep 25, 2008
INJEKT FILIFORM INJECTION NEEDLE
K082319 · FBK
Cook Urological, Inc.
Gastroenterology & Urology · 43d
Cleared Sep 25, 2008
SERIM DISINTEK OPA TEST STRIP
K082352 · JOJ
Serim Research Corp.
General Hospital · 40d
Cleared Sep 25, 2008
BISCEM TRANSLUCENT, MODEL D-45011
K082449 · EMA
Bisco, Inc.
Dental · 31d
Cleared Sep 25, 2008
TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T
K082636 · MOS
Quality Electrodynamics
Radiology · 15d
Cleared Sep 24, 2008
SELLAS
K080382 · GEX
Dinona Co., Ltd.
General & Plastic Surgery · 224d
Cleared Sep 24, 2008
XPERT MRSA/SA SSTI ASSAY
K080837 · NQX
Cepheid
Microbiology · 183d
Cleared Sep 24, 2008
NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT...
K081363 · FRO
Advanced Medical Solutions Limited
General & Plastic Surgery · 132d
Cleared Sep 24, 2008
SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL
K081371 · MKJ
Leonhard Lang GmbH
Cardiovascular · 132d
Cleared Sep 24, 2008
DAMON 4CLEAR
K081415 · NJM
Ormco Corp.
Dental · 127d
Cleared Sep 24, 2008
HEART SYNC PEDIATRIC, MODEL PED-100
K081442 · LDD
Heart Sync, LLC
Cardiovascular · 125d