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

Filters: Cleared only ×
176,076 results
62401–62424 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 2006
DEPUY GLOBAL AP SHOULDER SYSTEM
K060874 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Jun 28, 2006
JSZ MULTIACTION GP CONTACT LENS SOLUTION
K060924 · LPN
Szabocsik and Associates
Ophthalmic · 85d
Cleared Jun 28, 2006
SURGI-MAX
K061174 · GEI
Ellman Int'L, Inc.
General & Plastic Surgery · 62d
Cleared Jun 28, 2006
L4 OXYGEN CONCENTRATOR
K061261 · CAW
Respironics, Inc.
Anesthesiology · 54d
Cleared Jun 27, 2006
CAPILLARY'S HEMOGLOBIN(E) (PN 2007)
K052291 · GKA
Sebia
Hematology · 308d
Cleared Jun 27, 2006
THE DOUBLE GLOVE
K060030 · KGO
Biobarrier, Inc.
General Hospital · 174d
Cleared Jun 27, 2006
BOD POD
K060848 · OAC
Life Measurement, Inc.
Obstetrics & Gynecology · 91d
Cleared Jun 27, 2006
ZIMMER CONTOUR RESTORATIVE SYSTEM
K061043 · NHA
Zimmer Dental, Inc.
Dental · 74d
Cleared Jun 27, 2006
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A
K061210 · BSP
Kyphon, Inc.
Anesthesiology · 57d
Cleared Jun 27, 2006
V-2200 INFANT INCUBATOR
K061280 · FMZ
Neoforce Group, Inc.
General Hospital · 50d
Cleared Jun 27, 2006
NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)
K061360 · MYA
Lab Vision Corp.
Pathology · 42d
Cleared Jun 27, 2006
P.D
K061440 · MUJ
.Decimal, Inc.
Radiology · 34d
Cleared Jun 27, 2006
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
K061527 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 25d
Cleared Jun 27, 2006
GE DATEX-OHMEDA AISYS
K061609 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 18d
Cleared Jun 27, 2006
VITREA, VERSION 3.9
K061624 · LLZ
Vital Images, Inc.
Radiology · 15d
Cleared Jun 27, 2006
LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES
K061646 · FBO
Laserscope
Gastroenterology & Urology · 15d
Cleared Jun 27, 2006
MEDI-GLOBE ROTA-CUT SPHINCTEROTOME
K061684 · KNS
Medi-Globe Corporation
Gastroenterology & Urology · 12d
Cleared Jun 26, 2006
TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)
K051573 · EKM
Dr. Howard Martin, P.A.
Dental · 377d
Cleared Jun 26, 2006
ALLWOUND
K053476 · SEJ
At Squared, LLC
General & Plastic Surgery · 194d
Cleared Jun 26, 2006
RANGER IRRIGATION FLUID WARMING SYSTEM
K060939 · LGZ
Arizant Healthcare, Inc.
General Hospital · 81d
Cleared Jun 26, 2006
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN
K061159 · DQE
Hospira, Inc.
Cardiovascular · 61d
Cleared Jun 26, 2006
BLOOD PRESSURE METER, MODEL CH-311B
K061161 · DXN
Citizen Watch Co., Ltd.
Cardiovascular · 61d
Cleared Jun 26, 2006
PRE-IMPRESSION CONDITIONING SOLUTION
K061427 · ELW
Dentsply Intl.
Dental · 34d
Cleared Jun 26, 2006
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
K061487 · GXQ
Collagen Matrix, Inc.
Neurology · 26d