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
152905–152928 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 1984
HALO CO LASER SYSTEM
K841234 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 109d
Cleared Jul 09, 1984
FOREIGN BODY PROTECTOR
K841258 · FED
Jayco Pharmaceuticals
Gastroenterology & Urology · 105d
Cleared Jul 09, 1984
JEJUNOSTOMY SET FOR TUBE FEEDING
K841428 · KNT
Burron Medical Products, Inc.
Gastroenterology & Urology · 94d
Cleared Jul 09, 1984
AMER. PHARMASEAL SILICONIZED LATEX
K841544 · KOD
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 84d
Cleared Jul 09, 1984
PLUME FISTULA NEEDLE
K841791 · FIQ
Hospal Medical Corp.
Gastroenterology & Urology · 70d
Cleared Jul 09, 1984
VARIAN 3300 & 3400 GAS CHROMATOGRAPHS
K841891 · KZQ
Varian Assoc., Inc.
Chemistry · 63d
Cleared Jul 09, 1984
TRIGLYCERIDES-GPO REAGENT
K842029 · CDT
Reagents Applications, Inc.
Chemistry · 52d
Cleared Jul 09, 1984
VENTREZYME PHENYTOIN KIT IMMUNOASSAY
K842161 · DIP
Ventrex Laboratories, Inc.
Chemistry · 40d
Cleared Jul 09, 1984
TBG RIA
K842167 · CEE
Syncor Intl. Corp.
Chemistry · 39d
Cleared Jul 06, 1984
STERILE HICHMAN/BROVIAC INJECTION CAP
K840846 · LJS
Evermed, Inc.
General Hospital · 133d
Cleared Jul 06, 1984
MULTIVARIATE DIGITAL CARDIOGRAPH
K840875 · DQK
Clinical Microsystems Intl.
Cardiovascular · 130d
Cleared Jul 06, 1984
BEHRING ELISA PROCESSOR M
K841043 · JQW
Behring Diagnostics, Inc.
Chemistry · 116d
Cleared Jul 06, 1984
HOSPAL BIOSPAL SCU/CAVH KIT
K841152 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 109d
Cleared Jul 06, 1984
CURITY RIG FOLEY CATH TRAY
K841169 · KNX
The Kendal Co.
Gastroenterology & Urology · 109d
Cleared Jul 06, 1984
DACOMED RIGISCAN SYSTEM
K841202 · LIL
Dacomed Corp.
Gastroenterology & Urology · 107d
Cleared Jul 06, 1984
PULSE GENERATOR 678L
K841233 · DXY
Siemens Elema AB
Cardiovascular · 106d
Cleared Jul 06, 1984
RECTAL IRRIGATION TUBE
K841289 · KNT
Hdc Corp.
Gastroenterology & Urology · 100d
Cleared Jul 06, 1984
CAUSSE SPONGE BOAT
K841353 · ETB
Treace Medical, Inc.
Ear, Nose, Throat · 95d
Cleared Jul 06, 1984
CURETTE
K841354 · JYG
Treace Medical, Inc.
Ear, Nose, Throat · 95d
Cleared Jul 06, 1984
HEMO-RO WATER PURIFICATION SYS
K841403 · FIP
Millipore Corp.
Gastroenterology & Urology · 94d
Cleared Jul 06, 1984
RADIOGRAPHIC FILM PROCESSOR M-30CR &
K841431 · IXX
The Allen Products Co.
Radiology · 91d
Cleared Jul 06, 1984
SCANLAN ATRAUM INSTRUMENT JAW COVER
K841513
Scanlan Intl., Inc.
General & Plastic Surgery · 85d
Cleared Jul 06, 1984
SENTECH'S ULAB 1000 CLINICAL CHEM.
K841575 · CEM
Sen Tech Medical Corp.
Chemistry · 80d
Cleared Jul 06, 1984
BP TRAUMA AIR PANTS
K841605 · LHX
Bp Medical Systems, Inc.
Anesthesiology · 78d