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
171889–171912 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1978
FECATEST
K780564 · KHE
Otto C. Watzka
Hematology · 85d
Cleared Jun 30, 1978
EXTERNAL TEST PULSE GENERATOR
K780717 · DTC
Vitatron Medical BV
Cardiovascular · 64d
Cleared Jun 30, 1978
ELECTRO-PLETHYSMOGRAPH
K780761 · JOM
Biotecx Laboratories, Inc.
Cardiovascular · 52d
Cleared Jun 30, 1978
MICROPULSE 22S PACEMAKER
K780780 · DXY
Edwards Pacemaker Systems
Cardiovascular · 50d
Cleared Jun 30, 1978
SAFETY STOP NECKSTRAP
K780814 · DYT
Northwest Orthodontics, Inc.
Dental · 43d
Cleared Jun 30, 1978
CONTACT LENS CLEANSER
K780823 · HPX
Ketchum Laboratories, Inc.
Ophthalmic · 39d
Cleared Jun 30, 1978
CHARLES ENDOCOAGULATOR ACCESSORY FOR ARC
K780851 · HOB
Varian Assoc., Inc.
Ophthalmic · 39d
Cleared Jun 30, 1978
Y-TYPE BLOOD SET
K780880 · KDC
Abbott Laboratories
General & Plastic Surgery · 31d
Cleared Jun 30, 1978
INSTANT CURE-1
K780898 · EBZ
Ultra-Light Corp.
Dental · 28d
Cleared Jun 30, 1978
COTTON TIPPED POINT
K780929 · KXF
Young Dental Manufacturing Co. 1, LLC
General Hospital · 25d
Cleared Jun 30, 1978
AIRSTIRRUP PNEUMATIC ANKLE BRACE
K780979 · IQI
Aircast, Inc.
Physical Medicine · 21d
Cleared Jun 30, 1978
CERVICAL COLLAR
K780994 · IQK
Fox Instruments, Inc.
Physical Medicine · 16d
Cleared Jun 30, 1978
CHAIRS WITH CASTORS
K781001 · INM
Orthopedic Equipment Co., Inc.
Physical Medicine · 15d
Cleared Jun 30, 1978
AUTO-CON
K781007 · HPX
Barnes-Hind, Inc.
Ophthalmic · 11d
Cleared Jun 30, 1978
DX TOOTHBRUSH
K781018 · EFW
Lever Brothers Company, Inc.
Dental · 14d
Cleared Jun 30, 1978
PREMIER INLAY PLACER
K781034 · EKI
Premier Dental Products Co.
Dental · 11d
Cleared Jun 30, 1978
PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX
K781035 · EMN
Premier Dental Products Co.
Dental · 11d
Cleared Jun 30, 1978
ULTRASONIC DENTAL PROPHYLAXIS UNIT,SSM
K781044 · ELC
Litton Dental Products
Dental · 8d
Cleared Jun 29, 1978
ACU-TEST IN-HOME PREGNANCY TEST
K781049 · JHJ
Williams, the J.B. Co., Inc.
Immunology · 7d
Cleared Jun 28, 1978
IMMUNOZYME TOXOPLASMA ANTIBODY
K780352 · GLZ
Millipore Corp.
Microbiology · 117d
Cleared Jun 28, 1978
SAFETY SPRING GUIDES, TEFLON COATED
K780438 · DQX
C.R. Bard, Inc.
Cardiovascular · 100d
Cleared Jun 28, 1978
DENTAL AIR BRUSH
K780460 · KOH
M. Joel Gebhart, D.D.S.
Obstetrics & Gynecology · 98d
Cleared Jun 28, 1978
ECG PAPER, 3 CHANNEL
K780597 · DSF
Abco Dealers, Inc.
Cardiovascular · 79d
Cleared Jun 28, 1978
PREFORMED TOOTH POSITIONER
K780619 · KMY
Tp Laboratories, Inc.
Dental · 76d