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
171193–171216 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 1978
BAR, DISTRACTION
K781841 · JEC
Ace Orthopedic Manufacturing Co.
Orthopedic · 12d
Cleared Nov 08, 1978
OXYGENATOR, BLOOD BOS-10
K781842 · DTZ
Bentley Laboratories, Inc.
Cardiovascular · 12d
Cleared Nov 07, 1978
TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN
K780573 · LCP
Bd Becton Dickinson Vacutainer...
Hematology · 211d
Cleared Nov 07, 1978
GLYCOHEMOGLOBIN-SKREEN TEST KIT
K780819 · LCP
Eppendorf-Brinkmann, Inc.
Hematology · 174d
Cleared Nov 07, 1978
ANGIOGRAPHIC GUIDE WIRE
K781561 · DQX
Wilson Medical Instruments Co.
Cardiovascular · 56d
Cleared Nov 07, 1978
STIMULATOR, E.S.I. NEURO
K781670 · GZJ
Evolutionary Systems, Inc.
Neurology · 35d
Cleared Nov 07, 1978
HEMOGLOBIN, TESTING SYSTEM
K781851 · LCP
Isolab, Inc.
Hematology · 4d
Cleared Nov 06, 1978
DEVICE, FEMALE INCONTINENCE
K781863 · HHW
Eschmann Bros. & Walsh , Ltd.
Obstetrics & Gynecology
Cleared Nov 03, 1978
CLINITEX VIS-X ASPIRATING ACCESSORY
K780852 · HKP
Varian Assoc., Inc.
Ophthalmic · 165d
Cleared Nov 03, 1978
MYO-STIM
K781239 · IPF
Med General
Physical Medicine · 106d
Cleared Nov 03, 1978
AKRON MALE EXTERNAL CATHETER
K781433 · KNX
Latex Ind., Inc.
Gastroenterology & Urology · 74d
Cleared Nov 03, 1978
ISO-CARE KIT
K781539 · HMP
Nice-Pak Products, Inc.
General & Plastic Surgery · 56d
Cleared Nov 03, 1978
AMPLAID MARK 4 AND MARK 5
K781667 · GWJ
Amplaid USA, Inc.
Neurology · 39d
Cleared Nov 03, 1978
GAMMA RADIATION STERILIZATION PRECEDURE
K781668 · KYJ
Cutter Laboratories, Inc.
Orthopedic · 36d
Cleared Nov 03, 1978
COPPER-TRAP
K781696 · CAH
Olympic Medical Corp.
General Hospital · 24d
Cleared Nov 03, 1978
EXAMINER 10
K781698 · HJE
American Sterilizer Co.
General & Plastic Surgery · 24d
Cleared Nov 03, 1978
IONOTPHORETIC APPLICATOR
K781700 · KTB
Mcghan Medical Corp.
Physical Medicine · 24d
Cleared Nov 03, 1978
ALP REAGENT SET, ALKALINE PHOSPHATASE
K781718 · CJE
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
CPK REAGENT SET, NAD REDUCTION
K781719 · CGS
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
HBDH ENZYME KINETIC REAGENT SET
K781720 · JMK
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
REAGENT SET, CHOLESTEROL
K781721 · CHH
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
REAGENT SET, TOTAL PROTEIN
K781722 · CEK
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
GLUCOSE HEXOKINASE, AUTO K
K781723 · CFR
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
NAD REDUCTION METHOD, LACTATE PYRIVATE
K781724 · CFJ
Medical Analysis Systems, Inc.
Chemistry · 23d