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
66001–66024 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 2005
URITEK 151 URINE ANALYZER, MODEL TC-151
K042421 · KQO
Teco Diagnostics
Chemistry · 244d
Cleared May 09, 2005
UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES
K050116 · MEG
Uniqsafe Biomeditech Co., Ltd.
General Hospital · 111d
Cleared May 09, 2005
AMIGO INSULIN PUMP
K050312 · LZG
Nipro Diabetes Systems, Inc.
General Hospital · 90d
Cleared May 09, 2005
OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY
K050541 · HQF
Omniguide Communications, Inc.
Ophthalmic · 68d
Cleared May 09, 2005
BARRIER SURGICAL GOWNS
K050786 · FYA
Molnlycke Health Care
General Hospital · 42d
Cleared May 09, 2005
TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060
K050926 · MMX
Idev Technologies, Inc.
Cardiovascular · 26d
Cleared May 06, 2005
NON-STICK ELECTRODE
K043036 · GEI
Modern Medical Equipment Mfg., Ltd.
General & Plastic Surgery · 183d
Cleared May 06, 2005
ANTI-I.V. ENTERAL FEEDING SYSTEM
K043044 · KNT
Viasys Medsystems
Gastroenterology & Urology · 183d
Cleared May 06, 2005
LASER SYS*STIM 540, MODEL ME 540
K043586 · ILY
Mettler Electronics Corp.
Physical Medicine · 129d
Cleared May 06, 2005
VENTANA IMAGE ANALYSIS SYSTEM
K050012 · NQN
Tripath Imaging, Inc.
Pathology · 123d
Cleared May 06, 2005
PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION...
K050119 · JKM
Beckman Coulter, Inc.
Immunology · 108d
Cleared May 06, 2005
CONCENTRIC EMBOLIC PEARLS
K050470 · KRD
Concentric Medical, Inc.
Cardiovascular · 72d
Cleared May 06, 2005
ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE
K050593 · DIS
ACON Laboratories, Inc.
Toxicology · 59d
Cleared May 06, 2005
ATRIUM ICAST COVERED STENT
K050814 · JCT
Atrium Medical Corp.
General & Plastic Surgery · 36d
Cleared May 06, 2005
NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
K050829 · GCJ
Conmed Integrated Systems (Cmis)
General & Plastic Surgery · 35d
Cleared May 06, 2005
DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K050835 · OLW
Ge Healthcare
Neurology · 35d
Cleared May 06, 2005
MERIT PRELUDE SHEATH INTRODUCER
K050962 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 18d
Cleared May 06, 2005
SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)
K051052 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 11d
Cleared May 05, 2005
ALDAHOL III HIGH-LEVEL DISINFECTANT
K041360 · MED
Healthpoint, Ltd.
General Hospital · 349d
Cleared May 05, 2005
COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS
K041540 · FYA
Standard Textile Co., Inc.
General Hospital · 331d
Cleared May 05, 2005
ACCUCHANGER
K043409 · IYE
Direx Systems Corp.
Radiology · 146d
Cleared May 05, 2005
GUNTHER TULIP VENA CAVA FILTER SET
K043509 · DTK
Cook, Inc.
Cardiovascular · 136d
Cleared May 05, 2005
HEMONIR TM
K050014 · GLY
Nir Diagnostics, Inc.
Hematology · 122d
Cleared May 05, 2005
MEDX HOME
K050022 · ILY
Medx Electronics, Inc.
Physical Medicine · 120d