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
72505–72528 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 2003
READI-STRAND, MODEL PSSTRAND
K022705 · KXK
Worldwide Medical Technologies, LLC
Radiology · 299d
Cleared Jun 09, 2003
KAISHOU VAGINAL SPECULUM
K030761 · HIB
Jiangsu Kaishou Medical Apparatus...
Obstetrics & Gynecology · 90d
Cleared Jun 09, 2003
HOBBS MISTIFIER SPRAY CATHETER
K030765 · OCX
Hobbs Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 09, 2003
CARIES INDICATOR
K030807 · LFC
Confi-Dental Products Co.
Dental · 88d
Cleared Jun 09, 2003
SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM
K031609 · HRS
Swiss Orthopedic Solutions, Inc.
Orthopedic · 18d
Cleared Jun 09, 2003
GE VIVID 7, MODEL FC0003XX
K031663 · IYN
General Electric Co.
Radiology · 11d
Cleared Jun 06, 2003
GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100
K022926 · DXN
Genteel Technology Co., Ltd.
Cardiovascular · 306d
Cleared Jun 06, 2003
WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
K024280 · DCK
Wako Chemicals USA, Inc.
Chemistry · 165d
Cleared Jun 06, 2003
MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
K030332 · NYN
Bionicare Medical Technologies, Inc.
Neurology · 126d
Cleared Jun 06, 2003
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
K030738 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 88d
Cleared Jun 06, 2003
MSD CABLE REDUCTION SYSTEM
K030816 · KWP
Medtronic Sofamor Danek
Orthopedic · 84d
Cleared Jun 06, 2003
ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR...
K030842 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 81d
Cleared Jun 06, 2003
TESCERAFLO A2, MODEL T-21012P
K030951 · EBF
Bisco, Inc.
Dental · 72d
Cleared Jun 06, 2003
CALIBRATION PLASMA LMW HEPARIN
K030964 · JIS
Instrumentation Laboratory CO
Hematology · 71d
Cleared Jun 06, 2003
CONTROL PLASMA LMW HEPARIN
K030965 · GGN
Instrumentation Laboratory CO
Hematology · 71d
Cleared Jun 06, 2003
SYVA EMIT II PLUS AMPHETAMINES ASSAY
K031004 · DKZ
Dade Behring, Inc.
Toxicology · 67d
Cleared Jun 06, 2003
PLUS ORTHOPEDICS CEMENTED HIP STEM
K031165 · JDI
Plus Orthopedics
Orthopedic · 53d
Cleared Jun 06, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML
K031429 · LON
Bd Diagnostic Systems
Microbiology · 31d
Cleared Jun 06, 2003
AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL...
K031479 · DXN
Datex-Ohmeda, Inc.
Cardiovascular · 29d
Cleared Jun 06, 2003
CUFFLOK ANCHOR
K031519 · MAI
Mitek Worldwide
Orthopedic · 22d
Cleared Jun 06, 2003
SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE
K031573 · KTT
Synthes (Usa)
Orthopedic · 17d
Cleared Jun 06, 2003
BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY
K031594 · MEG
M.K. Meditech Co. , Ltd.
General Hospital · 16d
Cleared Jun 06, 2003
MEDELA PUMP IN STYLE ADVANCED BREAST PUMP
K031614 · HGX
Medela, Inc.
Obstetrics & Gynecology · 14d
Cleared Jun 06, 2003
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
K031629 · HKI
Canon USA, Inc.
Ophthalmic · 10d