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
157441–157464 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 1983
ANA-CHECK
K831463 · LKJ
Diagnostic Technology, Inc.
Immunology · 33d
Cleared Jun 08, 1983
CRP-CHECK
K831465 · DCN
Diagnostic Technology, Inc.
Immunology · 33d
Cleared Jun 08, 1983
RA-CHECK
K831467 · DHR
Diagnostic Technology, Inc.
Immunology · 33d
Cleared Jun 08, 1983
LEGIONELLA CYE AGAR BASE & BCYE SUPPL
K831469 · JSK
Oxoid U.S.A., Inc.
Microbiology · 33d
Cleared Jun 08, 1983
DAVRON PROF. SCRUB BRUSH-DRY/STERILE
K831488 · GEC
Minnetonka, Inc.
General & Plastic Surgery · 29d
Cleared Jun 08, 1983
ANGIOGRAPHY KIT W/ADDIT. COMPONENTS
K831509 · DQO
Mallinckrodt Critical Care
Cardiovascular · 28d
Cleared Jun 08, 1983
DELUXE ADJUST-ANGLE BOARD-BK4066
K831538 · ION
Fred Sammons, Inc.
Physical Medicine · 27d
Cleared Jun 08, 1983
ECONOMY PLASTIC SOCK-BK2084-AID
K831539 · ILD
Fred Sammons, Inc.
Physical Medicine · 27d
Cleared Jun 08, 1983
COMPRESSOGRIP ELASTIC STUMP SHRINKER#
K831540 · ILG
Fred Sammons, Inc.
Physical Medicine · 27d
Cleared Jun 08, 1983
REACHER & DOOR OPENER
K831545 · IKW
Fred Sammons, Inc.
Physical Medicine · 27d
Cleared Jun 08, 1983
ADAPTIVE PENS & LAP DESK
K831546 · ILP
Fred Sammons, Inc.
Physical Medicine · 27d
Cleared Jun 08, 1983
RAISED TOILET SEATS & NAIL CLIPPERS
K831547 · ILS
Fred Sammons, Inc.
Physical Medicine · 27d
Cleared Jun 08, 1983
SORBOTHANE VISCO INNER SOLE PAD
K831552 · KNP
Fred Sammons, Inc.
Physical Medicine · 27d
Cleared Jun 08, 1983
NEIN ALLERGEN DISC IN VAST VENTREX TEST
K831554 · DHB
Ventrex Laboratories, Inc.
Immunology · 26d
Cleared Jun 08, 1983
ORTHOFIX
K831576 · JEC
Electro-Biology, Inc.
Orthopedic · 23d
Cleared Jun 08, 1983
LA-STAPH IDENTIFICATION SYSTEM
K831918 · JWX
Immuno-Mycologics, Inc.
Microbiology
Cleared Jun 07, 1983
COMPRESSOGRIP TUBULAR ELASTIC BANDAGE
K831551 · FQM
Fred Sammons, Inc.
General Hospital · 26d
Cleared Jun 07, 1983
SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND
K837329
Carolina Medical Electronics
Radiology · 91d
Cleared Jun 03, 1983
SPIROTECH ST-5500
K823770 · BZG
Spirotech, Inc.
Anesthesiology · 171d
Cleared Jun 03, 1983
FLORET TONSIL & ADENOID SPONGES
K830264 · EFQ
Ritmed, Inc.
General & Plastic Surgery · 129d
Cleared Jun 03, 1983
PROTET HOLDERS-BLOCKS & ROLL
K830272 · FWZ
Ritmed, Inc.
General & Plastic Surgery · 129d
Cleared Jun 03, 1983
VENTURE II MONITORING SYSTEM
K830321 · DSF
Rae Medical Corp.
Cardiovascular · 123d
Cleared Jun 03, 1983
INFANT ELECTRODE BELT
K830362 · DRX
Sentry Medical Products, Inc.
Cardiovascular · 120d
Cleared Jun 03, 1983
MICROPAK MOIST HEAT PAD
K830981 · IME
Micropak Manufacturers, Inc.
Physical Medicine · 66d