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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
144073–144096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 1986
SKYLARK GB 1000
K861214 · GZJ
Peleg Intl. Co.
Neurology · 79d
Cleared Jun 18, 1986
IMPAX, MALE IMPOTENCE AID
K861468 · LKY
Lehigh Group
Gastroenterology & Urology · 58d
Cleared Jun 18, 1986
ENGSTROM ERICA II RESPIRATOR
K862025 · CBK
Gambro, Inc.
Anesthesiology · 21d
Cleared Jun 18, 1986
COMPASS CT STEREOTACTIC ADAPTATION SYSTEM
K862220 · HAW
Stereotactic Medical Systems, Inc.
Neurology · 7d
Cleared Jun 18, 1986
FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES
K862267 · BTO
Bivona Medical Technologies
Anesthesiology · 5d
Cleared Jun 17, 1986
RUBELLA IGG EIA TEST KIT
K853696 · LFX
Labsystems, Inc.
Microbiology · 285d
Cleared Jun 17, 1986
NEUROTECH-4 PROGRAM NEUROMUSCULAR STIMULATOR 281
K860314 · IPF
Neurotech, Inc.
Physical Medicine · 140d
Cleared Jun 17, 1986
NEUROTECH-16 PROGRAM SYSTEM CONTROLLER MODEL 280
K860315 · IPF
Neurotech, Inc.
Physical Medicine · 140d
Cleared Jun 17, 1986
VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM
K860464 · KLS
Abbott Laboratories
Toxicology · 131d
Cleared Jun 17, 1986
DISPOSABLE FLUSH DEVICE
K860681 · DRS
Hewlett-Packard Co.
Cardiovascular · 112d
Cleared Jun 17, 1986
THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND
K860704 · NZA
Keymed, Inc.
General Hospital · 111d
Cleared Jun 17, 1986
GOTTEX SUNGLASSES
K861021 · HQG
Private Eyes Sunglass Corp.
Ophthalmic · 91d
Cleared Jun 17, 1986
MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINAL
K861047 · LNK
Sharplan Industries, Inc.
Gastroenterology & Urology · 91d
Cleared Jun 17, 1986
POWERSTIM ELECTRONIC MUSCLE STIMULATOR
K861399
Bio-Med Systems Corp.
Physical Medicine · 63d
Cleared Jun 17, 1986
THREADED TITANIUM METAL BACKED ACETABULAR CUP
K861400 · LZO
Depuy, Inc.
Orthopedic · 63d
Cleared Jun 17, 1986
RESUSIKIT
K861482 · CAE
Begley Enterprises, Inc.
Anesthesiology · 56d
Cleared Jun 17, 1986
DELFIA (TM) HUMAN PROLACTIN
K861542 · CFT
Lkb Instruments, Inc.
Chemistry · 54d
Cleared Jun 17, 1986
ACUSON S328, L382, L538 & L312 TRANSDUCERS
K861578 · HGL
Acuson Computed Sonography
Obstetrics & Gynecology · 50d
Cleared Jun 17, 1986
GRAM NEGATIVE COMBO PANEL TYPE 3
K861584 · JWY
American Micro Scan
Microbiology · 49d
Cleared Jun 17, 1986
WECK INSTRUMENT CLEANER, CAT. NO. 850-103
K861588 · FLG
Palmetto Chemical & Supply Co., Inc.
General Hospital · 49d
Cleared Jun 17, 1986
WEC-KLEEN, CATALOG N. 850-102
K861590 · FLG
Palmetto Chemical & Supply Co., Inc.
General Hospital · 49d
Cleared Jun 17, 1986
WEC-WASH, CATALOG NO. 850-115
K861592 · FLG
Palmetto Chemical & Supply Co., Inc.
General Hospital · 49d
Cleared Jun 17, 1986
VISION TOTAL PROTEIN
K861798 · CEK
Abbott Laboratories
Chemistry · 39d
Cleared Jun 17, 1986
WAXTREAT B
K861800
Beaute Naturelle International, Inc.
General & Plastic Surgery · 39d