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
159337–159360 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 1982
DENDRITE VM-TRANSCUTANEOUS ELEC. NERVE
K823002 · GZJ
Tri W-G, Inc.
Neurology · 36d
Cleared Nov 17, 1982
DESERT INSYTE-A HYPERTHERMIA SENSOR ACC
K823066 · FLL
Parke-Davis Co.
General Hospital · 30d
Cleared Nov 17, 1982
DIALYSATE ADDITIVES-POWDER/LIQUID
K823103 · KPO
Di-Chem, Inc.
Hematology · 28d
Cleared Nov 17, 1982
RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA
K823121 · DFH
Amico Lab, Inc.
Microbiology · 23d
Cleared Nov 17, 1982
AIR FLOW I
K823133 · EIA
Healthco, Inc.
Dental · 23d
Cleared Nov 17, 1982
AIR FLOW II
K823134 · ELC
Healthco, Inc.
Dental · 23d
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