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

Filters: Cleared only ×
175,820 results
147385–147408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1985
SKYTRON ELITE 6000 & 6001 SURGICAL TABLES
K853480 · GDC
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 23d
Cleared Sep 12, 1985
OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE
K853486 · FGA
Olympus Corp.
Gastroenterology & Urology · 23d
Cleared Sep 12, 1985
MINIFILTER HEMOFILTER
K853510 · KDI
Amicon, Inc.
Gastroenterology & Urology · 22d
Cleared Sep 12, 1985
VELCRO TOURNIQUET
K853537 · GAX
Cp Medical
General & Plastic Surgery · 20d
Cleared Sep 12, 1985
CANNULA CLAMP
K853538 · HXD
Cp Medical
General & Plastic Surgery · 20d
Cleared Sep 12, 1985
APL TRYPTIC SOY BROTH
K853609 · JSD
Apl Medical Supplies
Microbiology · 14d
Cleared Sep 12, 1985
APL XYLOSE LYSINE DEOXYCHOLATE AGAR
K853611 · JSI
Apl Medical Supplies
Microbiology · 14d
Cleared Sep 11, 1985
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO
K851242 · FGE
Cook, Inc.
Gastroenterology & Urology · 197d
Cleared Sep 11, 1985
VSM-5
K852322 · DPS
Physio-Control Corp.
Cardiovascular · 104d
Cleared Sep 11, 1985
ACUFEX COMPARATIVE SURGICAL KERATOMETER
K852424 · HJB
Acufex Microsurgical, Inc.
Ophthalmic · 96d
Cleared Sep 11, 1985
VISITEC IRRIGATION CONTROL SYSTEM
K853243 · KYG
Visitec Co.
Ophthalmic · 41d
Cleared Sep 11, 1985
SIMPLEX ENHANCEMENT MIXER
K853310 · JDZ
Howmedica Corp.
Orthopedic · 35d
Cleared Sep 11, 1985
BEAR NICU-1
K853346 · BZK
Bear Medical Systems, Inc.
Anesthesiology · 30d
Cleared Sep 11, 1985
H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT
K853366 · JXG
Holter-Hausner Intl.
Neurology · 30d
Cleared Sep 11, 1985
H-H BURR HOLE CATHETER SUPPORT
K853367 · GXR
Holter-Hausner Intl.
Neurology · 21d
Cleared Sep 11, 1985
H-H FIXATION & JOINING CONNECTORS
K853369 · JXG
Holter-Hausner Intl.
Neurology · 30d
Cleared Sep 11, 1985
TRAUMA TABLE
K853535 · GDC
Xre Corp.
General & Plastic Surgery · 19d
Cleared Sep 11, 1985
STERILE BIOPSY NEEDLES
K853559
Plasmedics, Inc.
General & Plastic Surgery · 16d
Cleared Sep 11, 1985
DIALYZER, CAPILLARY, HOLLOW FIBER
K853591 · FJI
Organon Teknika Corp.
Gastroenterology & Urology · 15d
Cleared Sep 10, 1985
MARLIN SOFT LENS TWEEZER
K850983 · KYE
Marlin Industries
Ophthalmic · 183d
Cleared Sep 10, 1985
MARLIN SOFT LENS HANDLER
K850984 · KYE
Marlin Industries
Ophthalmic · 183d
Cleared Sep 10, 1985
MEDIPART LUNG AEROSOL KIT MP-1012A
K851198 · IYT
Medipart Jerry Alexander
Radiology · 168d
Cleared Sep 10, 1985
MEDIPART LUNG AEROSOL KIT MP-1012A-M
K851199 · IYT
Medipart Jerry Alexander
Radiology · 168d
Cleared Sep 10, 1985
MEDIPART LUNG AEROSOL KIT MP-1024A
K851200 · IYT
Medipart Jerry Alexander
Radiology · 168d