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
61201–61224 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 2006
XERON PACS
K062757 · LLZ
Xeron Healthcare Corp.
Radiology · 54d
Cleared Nov 07, 2006
I-STOP TRANS OBTURATOR MALE SLING
K063079 · OTM
Cl Medical
Gastroenterology & Urology · 28d
Cleared Nov 07, 2006
SECTRA WORKSTATION, VERSION 11.1
K063093 · LLZ
Sectra-Imtec AB
Radiology · 28d
Cleared Nov 06, 2006
CELLU M6 KEYMODULE I
K053225 · ISA
Lpg One, Inc.
Physical Medicine · 354d
Cleared Nov 06, 2006
NICOLETONE SYSTEM V32 AMPLIFIER
K061908 · GWQ
Viasys Neuro Care
Neurology · 124d
Cleared Nov 06, 2006
CRYOMATIC
K062412 · HRN
Keeler Instruments, Inc.
Ophthalmic · 81d
Cleared Nov 06, 2006
TSRH SPINAL SYSTEM
K062807 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 48d
Cleared Nov 06, 2006
ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019
K062886 · EBC
CAO Group, Inc.
Dental · 41d
Cleared Nov 06, 2006
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K063083 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Nov 03, 2006
SONARA
K060421 · IYN
Viasys Healthcare, Inc.
Radiology · 259d
Cleared Nov 03, 2006
SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE
K061233 · LYY
Pt Mahakarya Inti Buana
General Hospital · 185d
Cleared Nov 03, 2006
POLY-CHEM CREATININE
K061944 · JFY
Polymedco, Inc.
Chemistry · 116d
Cleared Nov 03, 2006
EQUIVITAL, MODEL EQ-01
K061993 · MHX
Hidalgo Limited
Cardiovascular · 112d
Cleared Nov 03, 2006
MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES
K062454 · LNH
Siemens Medi Cal Solutions, Inc.
Radiology · 73d
Cleared Nov 03, 2006
PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL
K062455 · DQA
Philips Medical Systems
Anesthesiology · 72d
Cleared Nov 03, 2006
VOYAGER 12
K062469 · DPS
Del Mar Reynolds Medical, Ltd.
Cardiovascular · 71d
Cleared Nov 03, 2006
VENTED VIAL ADAPTER TRANSFER DEVICE
K062482 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 71d
Cleared Nov 03, 2006
TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA
K062597 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 63d
Cleared Nov 03, 2006
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER...
K062671 · MSD
Kendall
Gastroenterology & Urology · 56d
Cleared Nov 03, 2006
SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE, YELLOW
K062715 · LYZ
Baoding Guanzhong Glove Co., Ltd.
General Hospital · 53d
Cleared Nov 03, 2006
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN
K062999 · DQE
Hospira, Inc.
Cardiovascular · 32d
Cleared Nov 03, 2006
CONFIDENCE FENESTRATED INTRODUCER NEEDLE
K063067 · NDN
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 28d
Cleared Nov 03, 2006
MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX
K063117 · GXQ
Medtronic Neurosurgery
Neurology · 22d
Cleared Nov 03, 2006
MODIFICATION TO SILVER ALGINATE II WOUND DRESSING
K063173 · FRO
Advanced Medical Solutions Limited
General & Plastic Surgery · 15d