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
140209–140232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 1987
LUTEMOLL (BIOPLAST)
K871038 · EBI
B. L. Dental Co.
Dental · 63d
Cleared May 19, 1987
DMI AMBULATORY HOLTER MONITOR
K871045 · DSH
Diagnostic Medical Instruments
Cardiovascular · 63d
Cleared May 19, 1987
TELSTAR MODEL 0/3 HEARING AID
K871519 · ESD
Telstar Electronics, Inc.
Ear, Nose, Throat · 29d
Cleared May 19, 1987
DAHLBERG MODEL UL IN-THE-EAR HEARING AID
K871525 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 29d
Cleared May 19, 1987
BABYSET(TM) MODIFIED JACKSON-REES CIRCUIT W/VALVE
K871669 · CAI
Life Design Systems, Inc.
Anesthesiology · 21d
Cleared May 19, 1987
MCCONNELL ORTHOPEDIC STERILE ARTICULATED ARM
K871703 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 18d
Cleared May 19, 1987
MCCONNELL ORTHOPEDIC UNIVERSAL POSITIONER (MUP)
K871803 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 11d
Cleared May 19, 1987
MCCONNEL ORTHOPEDIC ARTHROSCOPY SUPPORT ASSEMBLY
K871804 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 11d
Cleared May 19, 1987
MCCONNELL ORTHOPEDIC STERILE UPRIGHT SUPPORT
K871805 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 11d
Cleared May 18, 1987
CYCLO-BRUSH
K870782 · HHT
Medline Industries, Inc.
Obstetrics & Gynecology · 81d
Cleared May 18, 1987
MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.
K871029 · LNK
Directed Energy, Inc.
Gastroenterology & Urology · 63d
Cleared May 18, 1987
MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.
K871032 · LNK
Directed Energy, Inc.
Gastroenterology & Urology · 63d
Cleared May 18, 1987
TOPCON COMPUTERIZED TONOMETER CT-10
K871335 · HKX
Topcon Instrument Corporation of America
Ophthalmic · 45d
Cleared May 18, 1987
KIRSCHNER MODULAR HIP SYSTEM
K871401 · JDI
Kirschner Medical Corp.
Orthopedic · 40d
Cleared May 18, 1987
REAGENTS 1263,1273,1284,1425,014301,053583
K871531 · CIG
American Research Products Co.
Chemistry · 28d
Cleared May 18, 1987
ANESTHASSIST
K871564 · BRY
Anestech, Inc.
Anesthesiology · 26d
Cleared May 18, 1987
ORMCO GEL-ETCH
K871591 · DYH
Scientific Pharmaceuticals, Inc.
Dental · 24d
Cleared May 18, 1987
ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540
K871611 · HKO
Allergan Humphrey
Ophthalmic · 38d
Cleared May 18, 1987
DENTAL DIAMOND BURS
K871639 · DZP
E&D Dental Manufacturing Co.
Dental · 21d
Cleared May 18, 1987
TANNE CORNEAL CUTTING BLOCK
K871646 · HNJ
Ocular Instruments, Inc.
Ophthalmic · 20d
Cleared May 18, 1987
ENZYMATIC CHOLESTEROL REAGENT SET
K871676 · CHH
Michclone Associates, Inc.
Chemistry · 20d
Cleared May 18, 1987
OPTHA PREP
K871706 · HMT
Treace Medical, Inc.
General Hospital · 17d
Cleared May 18, 1987
MODIFIED USE OF PULL-APART INTRODUCER SET
K871730 · FKO
Quinton, Inc.
Gastroenterology & Urology · 13d
Cleared May 15, 1987
GASTROTOPO
K861291 · FGE
Houston Biomedical, Inc.
Gastroenterology & Urology · 403d