FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
71377–71400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 2003
CONTEC LIGHT
K030641 · EBZ
Dentaurum
Dental · 102d
Cleared Jun 10, 2003
COOL CURE
K030811 · EBZ
Samm, Inc.
Dental · 89d
Cleared Jun 10, 2003
POWDERED VINYL EXAM GLOVES, WHITE
K031104 · LYZ
Glormed Intl., Inc.
General Hospital · 64d
Cleared Jun 10, 2003
DISPOSABLE POWDER FREE VINYL EXAM GLOVES
K031113 · LYZ
Elite International, Inc.
General Hospital · 63d
Cleared Jun 10, 2003
KLINIDRAPE SURGICAL DRAPES
K031131 · KKX
Molnlycke Health Care
General Hospital · 62d
Cleared Jun 10, 2003
HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY
K031348 · NHG
Salimetrics, LLC
Chemistry · 60d
Cleared Jun 10, 2003
DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
K031569 · DSP
Datascope Corp.
Cardiovascular · 21d
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