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
153529–153552 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1984
CREATININE - A.A.S.
K841377 · CGX
Advanced Analytical Systems, Inc.
Chemistry · 38d
Cleared May 11, 1984
SODIUM & POTASSIUM STANDARD SOLUT
K841419 · JIX
Reagent Laboratory, Inc.
Chemistry · 36d
Cleared May 11, 1984
SODIUM & POTASSIUM STANDARD SOL 80
K841420 · JIX
Reagent Laboratory, Inc.
Chemistry · 36d
Cleared May 11, 1984
DAILY WASH SOLUTION 5
K841421 · JJO
Reagent Laboratory, Inc.
Chemistry · 36d
Cleared May 11, 1984
VOLUME TEST DYE 6
K841422 · JJO
Reagent Laboratory, Inc.
Chemistry · 36d
Cleared May 11, 1984
VENTRESCREEN, MULTIPLE ALLERGEN DISCS
K841516 · DHB
Ventrex Laboratories, Inc.
Immunology · 29d
Cleared May 11, 1984
ACA TRICYCLIC ANTIDEPRESSANTS SCREEN
K841533 · LAS
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 25d
Cleared May 11, 1984
OMNIDIRECTIONAL POWERED WHEEL CHAIR
K841542 · ITI
Kinetic Concepts, Inc.
Physical Medicine · 25d
Cleared May 11, 1984
OPTIMATE DIGOXIN TEST
K841582 · KXT
Miles Laboratories, Inc.
Toxicology · 24d
Cleared May 11, 1984
KF STREPTOCOCCUS AGAR
K841658 · JSJ
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared May 11, 1984
SYNTHETIC BROTH A.O.A.C.
K841661 · JST
Oxoid U.S.A., Inc.
Microbiology · 18d
Cleared May 11, 1984
WALK & ROLL
K841700 · INM
Maddak, Inc.
Physical Medicine · 18d
Cleared May 11, 1984
DULBECCO'S PHOSPHATE BUFFERED SALINE
K841744 · KIT
Sigma Chemical Co.
Pathology · 14d
Cleared May 11, 1984
HEKTOEN ENTERIC AGAR
K841745 · JSI
The Montana Deaconess Medical Center
Microbiology · 14d
Cleared May 10, 1984
MEDPAR SURGICAL IMPLANTS
K832283 · FWP
Porex Medical
General & Plastic Surgery · 303d
Cleared May 10, 1984
IN-THE-EAR HEARING AID RX10 & 20
K840891 · ESD
Audio-Aid, Inc.
Ear, Nose, Throat · 73d
Cleared May 10, 1984
MULTIPLEX I, INTERFERENTIAL CURRENT
K841579 · IPF
Houwers Enterprises , Ltd.
Physical Medicine · 23d
Cleared May 10, 1984
MEDIUM FREQ. ELECTRICAL MUSCLE STIMULA
K841598
Chattanooga Group, Inc.
Physical Medicine · 22d
Cleared May 10, 1984
CRAWLER
K841695 · KNL
Maddak, Inc.
Physical Medicine · 17d
Cleared May 10, 1984
HEAT PACK
K841698 · IMA
Maddak, Inc.
Physical Medicine · 17d
Cleared May 09, 1984
CARDIO TRACE ELECTRODE
K832429 · DRX
Poly-Med Splint Co.
Cardiovascular · 292d
Cleared May 09, 1984
CENTURION CARDIAC DETECTOR
K832828 · DRJ
Clinical Data Instruments, Inc.
Cardiovascular · 264d
Cleared May 09, 1984
SONEL 3000A
K833223 · IYO
Cgr Medical Corp.
Radiology · 244d
Cleared May 09, 1984
FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN
K833593 · DPS
Brentwood Instruments, Inc.
Cardiovascular · 210d