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
67585–67608 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 2004
OTOMIMIX
K042516 · NEA
Walter Lorenz Surgical, Inc.
Ear, Nose, Throat · 53d
Cleared Nov 08, 2004
SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
K042527 · HHT
Medical Action Industries, Inc.
Obstetrics & Gynecology · 52d
Cleared Nov 08, 2004
SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL...
K042537 · DQY
Invatec Innovative Technologies
Cardiovascular · 49d
Cleared Nov 08, 2004
SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL...
K042538 · DQY
Invatec Innovative Technologies
Cardiovascular · 49d
Cleared Nov 08, 2004
MULTI CHEM CAL B
K042549 · JIX
Wako Chemicals USA, Inc.
Chemistry · 49d
Cleared Nov 08, 2004
MULTI-LIPID CALIBRATOR
K042550 · JIX
Wako Chemicals USA, Inc.
Chemistry · 49d
Cleared Nov 08, 2004
INNOJECT AUTO-INJECTOR
K042557 · KZH
Innoject, Inc.
General Hospital · 49d
Cleared Nov 08, 2004
VASC-ALERT
K042566 · MQS
Vasc-Alert, Inc.
Gastroenterology & Urology · 48d
Cleared Nov 08, 2004
IMAGE MEDICAL ACQUISITION STATION (IMAS)
K042700 · LLZ
Erad Imagemedical Corp.
Radiology · 39d
Cleared Nov 08, 2004
MAMMOTOME MR BIOPSY SYSTEM
K042753 · KNW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 35d
Cleared Nov 08, 2004
VIVOSORB SHEET, MODEL FS01
K042811 · FTL
Polyganics B.V.,
General & Plastic Surgery · 27d
Cleared Nov 08, 2004
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K042969 · FGE
Cordis Corp.
Gastroenterology & Urology · 11d
Cleared Nov 05, 2004
T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303
K040684 · MUD
Spectros Corporation
Cardiovascular · 234d
Cleared Nov 05, 2004
RANDOX BARBITURATE ASSAY
K041143 · DIS
Randox Laboratories, Ltd.
Toxicology · 189d
Cleared Nov 05, 2004
TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
K041367 · HKI
Topcon Corp.
Ophthalmic · 165d
Cleared Nov 05, 2004
BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER
K041464 · EZD
Busse Hospital Disposables
Gastroenterology & Urology · 156d
Cleared Nov 05, 2004
MININEPH HUMAN RHEUMATOID FACTOR KIT
K041891 · DHR
The Binding Site
Immunology · 116d
Cleared Nov 05, 2004
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
K042230 · DQY
Cryo Vascular Systems, Inc.
Cardiovascular · 80d
Cleared Nov 05, 2004
KENDALL CO2NFIRM NOW CO2 DETECTOR
K042572 · KNT
Kendall
Gastroenterology & Urology · 45d
Cleared Nov 05, 2004
CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE
K042615 · FBK
Carbon Medical Technologies, Inc.
Gastroenterology & Urology · 42d
Cleared Nov 05, 2004
31P/1H HEADCOIL FOR MAGNETOM ALLEGRA
K042617 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 42d
Cleared Nov 05, 2004
ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING...
K042619 · MUI
Sonotech, Inc.
Radiology · 42d
Cleared Nov 05, 2004
MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
K042717 · JJX
Medical Analysis Systems, Inc.
Chemistry · 36d
Cleared Nov 05, 2004
ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE
K042796 · HWC
Coapt Systems, Inc.
Orthopedic · 29d