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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
168097–168120 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 05, 1979
CONPHAR FACE MASK-STERILE
K792110 · FXX
Conphar, Inc.
General Hospital · 11d
Cleared Oct 30, 1979
OREIA-TU THYROID UPTAKER RATIO ASSAY
K791172
Organon, Inc.
Chemistry · 127d
Cleared Oct 30, 1979
VERI-VU LENSOMETER
K791521 · HLM
Intermedics, Inc.
Ophthalmic · 81d
Cleared Oct 30, 1979
WARM-EE HEAT PACK
K791684 · IME
U.S. Export Marketing Group, Inc.
Physical Medicine · 63d
Cleared Oct 30, 1979
MODEL H44-80 BEHIND THE EAR HEARING
K791745 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 50d
Cleared Oct 30, 1979
3M UPF PROXIMAL FEMUR REPLACEMENT SYSTEM
K791823 · KWY
3M Company
Orthopedic · 46d