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
148801–148824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 1985
EARETTE HEARING AID(BEHIND THE EAR OTICON E37F
K851430 · ESD
Oticon Corp.
Ear, Nose, Throat · 49d
Cleared May 29, 1985
BEHIND THE EAR HEARING AID MODEL BERNAFON T-82
K851547 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 43d
Cleared May 29, 1985
VERA BOND NON PERCIOUS CERAMIC ALLOY
K851569 · EJH
Aalba Dent, Inc.
Dental · 42d
Cleared May 29, 1985
RAKA OCH BOSDA PEANGER
K851673 · GEN
General Electric Trading Co.
General & Plastic Surgery · 36d
Cleared May 29, 1985
1-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS.
K851746 · ERA
Artiberia
Ear, Nose, Throat · 34d
Cleared May 29, 1985
IMAX PERIOTIPS
K851841
Stram Dental, Inc.
Dental · 33d
Cleared May 29, 1985
UN(UREASE)REAGENT UN(A-KETO)REAGENT
K851991 · KNK
Alpkem Corp.
Chemistry · 22d
Cleared May 29, 1985
GLU(GOD) REAGENT
K851992 · CGA
Alpkem Corp.
Chemistry · 22d
Cleared May 29, 1985
UA(URICASE) REAGENT
K852004 · KNK
Alpkem Corp.
Chemistry · 22d
Cleared May 29, 1985
GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER
K852027 · DKJ
Advanced Biomedical Methods, Inc.
Toxicology · 21d
Cleared May 29, 1985
HEALTH-O-METER PHYSICIANS, DIGITAL ELEC SCALES
K852035 · FRW
Continental Scale Corp.
General Hospital · 20d
Cleared May 28, 1985
ACCU-TRAC
K843055 · DXN
Olympic Medical Corp.
Cardiovascular · 298d
Cleared May 28, 1985
MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO
K843580 · DRS
Graphic Controls Corp.
Cardiovascular · 259d
Cleared May 28, 1985
CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC
K844116 · DXG
Critikon Company, LLC
Cardiovascular · 217d
Cleared May 28, 1985
SPACELABS-GENERAL SYSTEM LINK
K850627 · DQK
Spacelabs, Inc.
Cardiovascular · 98d
Cleared May 28, 1985
AIR COMPRESSOR
K850795 · BTI
Bear Medical Systems, Inc.
Anesthesiology · 110d
Cleared May 28, 1985
V.E.P. HIP -VARIABLE ENDO-PROSTHESIS
K850928 · KWL
Unitas Ent.
Orthopedic · 84d
Cleared May 28, 1985
EXPOSCOP MOBILE IMAGING SYSTEM
K851031 · JAA
Euro-Electronics, Inc.
Radiology · 77d
Cleared May 28, 1985
ZWEYMULLER CUP
K851213 · KWA
Allo Pro Corp.
Orthopedic · 63d
Cleared May 28, 1985
BFW VOICE GENERATOR
K851462 · BTO
Bfw Laboratories, Inc.
Anesthesiology · 46d
Cleared May 28, 1985
ALLERGENETICS IGE FAST TEST
K851512 · DHB
Allergenetics
Immunology · 43d
Cleared May 28, 1985
SLIT CAMERA MODEL 07-624
K851811 · IXH
Victoreen, Inc.
Radiology · 32d
Cleared May 24, 1985
XMC-S TUBESTAND XMT-S TABLE XMH-NTWALL
K842094 · IXQ
X-Ray Mfg. & Sales, Inc.
Radiology · 364d
Cleared May 24, 1985
COOK COUNTY HOSPITAL DRESSING CHANGE SET
K843206 · KDD
Geneva Laboratories, Inc.
General & Plastic Surgery · 282d