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
168937–168960 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1979
(MICRO-KERATRON, MICRO DUCT TREPHINE)
K791763 · HRG
Intl. Ophthalmic Industries Corp.
Ophthalmic · 61d
Cleared Nov 05, 1979
MASTERSON* ENDOMETRIAL BIOPSY KIT
K791765 · HHK
Codman & Shurtleff, Inc.
Obstetrics & Gynecology · 69d
Cleared Nov 05, 1979
CORDIS PERMANENT PERVENOUS CARDIAC LEADS
K791768 · DTB
Cordis Corp.
Cardiovascular · 61d
Cleared Nov 05, 1979
SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM
K791812 · IXR
Spectrum X-Ray Corp.
Radiology · 48d
Cleared Nov 05, 1979
HOLLOW FIBER DIALIZER MODEL TRIEX-3
K791857
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 47d
Cleared Nov 05, 1979
ROYCO MODEL 921 CELL COUNTER
K791867 · GKL
Royco Instruments
Hematology · 45d
Cleared Nov 05, 1979
DISPOSABLE SPECIALITY SPONGES
K791870 · GDI
Carwild Corp.
General & Plastic Surgery · 45d
Cleared Nov 05, 1979
NEUROLOGICAL SPONGES (PATTIES)
K791871 · EFQ
Carwild Corp.
General & Plastic Surgery · 45d
Cleared Nov 05, 1979
RIONET HEARING AID HB-64C
K791878 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 66d
Cleared Nov 05, 1979
RIONET HEARING AID HB-64T
K791880 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 66d
Cleared Nov 05, 1979
RIONET HEARING AID HB-65T
K791881 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 66d
Cleared Nov 05, 1979
TAPE-A-TRACE
K791892 · DXM
Instromedix, Inc.
Cardiovascular · 41d
Cleared Nov 05, 1979
PELICAN BAY KEL-COR CEPHALOMETRIC SYS.
K791916 · IXY
Pelican Bay Kel-Cor
Radiology · 41d
Cleared Nov 05, 1979
WORTHINGTON TRIGLYCERIDES REAGENT SET
K791962 · JGY
Worthington Diagnostic Systems
Chemistry · 35d
Cleared Nov 05, 1979
DYNACOR STERILE CLOSED SYS. DRAINAGE BAG
K791969 · KNX
Medline Industries, Inc.
Gastroenterology & Urology · 34d
Cleared Nov 05, 1979
MONOJECT SICKLE CELL KIT
K791971 · GHM
Sherwood Medical Co.
Immunology · 34d
Cleared Nov 05, 1979
HEWSON LIGAMENT BUTTON
K792004 · KGS
Richard'S Medical Equip., Inc.
General & Plastic Surgery · 33d
Cleared Nov 05, 1979
PHADECODE XA INHIBITOR ASSAY
K792019 · JBQ
Pharmaseal Div., Baxter Healthcare Corp.
Hematology · 27d
Cleared Nov 05, 1979
LANCER COAGENT PT KIT
K792031 · GJS
Sherwood Medical Co.
Toxicology · 27d
Cleared Nov 05, 1979
LANCER COAGENT APTT KIT
K792048 · GGW
Sherwood Medical Co.
Hematology · 24d
Cleared Nov 05, 1979
FISHER DIAGNOSTICS HEMATOLOGY CONTROLS
K792055 · JPK
Fisher Scientific Co., LLC
Hematology · 21d
Cleared Nov 05, 1979
MODEL 685/686 DYNAMIC ELECTROCARDI0-
K792072 · DPS
Del Mar Avionics
Cardiovascular · 21d
Cleared Nov 05, 1979
MODEL 1979 BLOOD PRESSUROMETER R CHARTER
K792073 · DRS
Del Mar Avionics
Cardiovascular · 21d
Cleared Nov 05, 1979
CONPHAR O.R. HEAD COVER-STERILE
K792106 · FYI
Conphar, Inc.
General & Plastic Surgery · 11d