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
170353–170376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 03, 1978
REAGENT SET, U.V. ENZMATIC KINETIC, SGOT
K781725 · CIT
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
REAGENT SET, SGPT SERUM GLUTAMIC
K781726 · CKA
Medical Analysis Systems, Inc.
Chemistry · 23d
Cleared Nov 03, 1978
DISC, COLOPLAST PRE-OP STOMA
K781736 · EXA
C.R. Bard, Inc.
Gastroenterology & Urology · 22d
Cleared Nov 03, 1978
SCANNER, CT 0450
K781752 · JAK
Pfizer Medical Systems, Inc.
Radiology · 16d
Cleared Nov 03, 1978
TOMOGSCANNER 2
K781753 · KPS
Tomogscanner OK , Ltd.
Radiology · 17d
Cleared Nov 03, 1978
FRAME, UNIVERSAL DAY
K781793 · JEC
B.G. Orthopedic Corp.
Orthopedic · 9d