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
158497–158520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 1982
HEAVY-DUTY I.V. STAND
K823270 · FOX
E.F. Brewer Co.
General Hospital · 15d
Cleared Nov 16, 1982
GFB-B CONTACT LENS BLANKS
K822315 · HPX
Hamel, Park, Mccabe & Saunders
Ophthalmic · 105d
Cleared Nov 16, 1982
CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT
K822327 · KRZ
Interscience, Inc.
Hematology · 105d
Cleared Nov 16, 1982
225 S.I.M.V. VENTILATOR
K822635 · CBK
Monaghan Medical Corp.
Anesthesiology · 77d
Cleared Nov 16, 1982
THE EMD TENZ PAIN CONTROL SYSTEM
K822841 · GZJ
Electro Medical Development
Neurology · 54d
Cleared Nov 16, 1982
INTRACRANIAL PRESSURE MONITORING DEVICE
K822864 · GWM
Medex, Inc.
Neurology · 50d
Cleared Nov 16, 1982
ENTERAL NUTRITION 1
K822879 · KNT
Exco, Inc.
Gastroenterology & Urology · 50d
Cleared Nov 16, 1982
OHIO CPU-1 INTENSIVE CARE VENTILATOR
K822888 · CBK
Ohio Medical Products
Anesthesiology · 49d
Cleared Nov 16, 1982
BEAR VM-90 VENTILATION MONITOR
K822912 · BZK
Bear Medical Systems, Inc.
Anesthesiology · 46d
Cleared Nov 16, 1982
MICROTECH BACTERIAL CONTROLS
K822954 · JTR
Universal Micro Reference Laboratory
Microbiology · 43d
Cleared Nov 16, 1982
MICROFLUOR B PLATE & MICRO FLUOR W PLATE
K822960 · LIB
Dynatech Corp.
Chemistry · 42d
Cleared Nov 16, 1982
MICROFLUOR B REMOVAWELL STRIPS
K822962 · LIB
Dynatech Corp.
Chemistry · 42d
Cleared Nov 16, 1982
SALIVA SUBSTITUTE
K822971 · LFD
Roxane Laboratories, Inc.
Dental · 39d
Cleared Nov 16, 1982
HYPOCOUNT A
K822976 · CGA
Pharmaquest Corp.
Chemistry · 39d
Cleared Nov 16, 1982
HEMOGLOBIN ALC BY COLUMN TEST
K822977 · LCP
Bio-Rad
Hematology · 39d
Cleared Nov 16, 1982
PULMONARY FUNCTION LAB SYSTEM 1070
K822986 · BZC
Medical Graphics Corp.
Anesthesiology · 35d
Cleared Nov 16, 1982
CORN MEAL AGAR W/POLYSORBATE 80
K822994 · JSJ
Granite Diagnostics, Inc.
Microbiology · 35d
Cleared Nov 16, 1982
ANDRADES FERMENTATION MEDIA
K822995 · JSF
Granite Diagnostics, Inc.
Microbiology · 35d
Cleared Nov 16, 1982
JORDANS TARTRATE AGAR
K822996 · JSF
Granite Diagnostics, Inc.
Microbiology · 35d
Cleared Nov 16, 1982
CHRISTENSENS CITRATE SULFIDE AGAR
K822998 · JSE
Granite Diagnostics, Inc.
Microbiology · 35d
Cleared Nov 16, 1982
DNASE TEST AGAR W/TOLUIDINE BLUE
K822999 · JSF
Granite Diagnostics, Inc.
Microbiology · 35d
Cleared Nov 16, 1982
MACATE BROTH
K823000 · JSF
Granite Diagnostics, Inc.
Microbiology · 35d
Cleared Nov 16, 1982
PEPTONE IRON AGAR
K823001 · JSF
Granite Diagnostics, Inc.
Microbiology · 35d
Cleared Nov 16, 1982
KM-KAL 3
K823019 · JIT
Kmn Products, Inc.
Chemistry · 34d