FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
144505–144528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1986
SPECTACLES FRAME
K860954 · HQZ
Roseburg SA
Ophthalmic · 18d
Cleared Mar 31, 1986
SPECTACLES LENS
K860955 · HQG
Roseburg SA
Ophthalmic · 18d
Cleared Mar 31, 1986
RARE EARTH INTRA-OCULAR MAGNET
K860960 · HPN
Ameritek, Inc.
Ophthalmic · 18d
Cleared Mar 31, 1986
MODEL 366-19 ADAPTAID ADAPTER SLEEVE
K860985 · DTB
Intermedics, Inc.
Cardiovascular · 14d
Cleared Mar 31, 1986
MODEL 366-09 ADAPTAID ADAPTER SLEEVE
K860986 · DTB
Intermedics, Inc.
Cardiovascular · 14d
Cleared Mar 31, 1986
ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)
K861013 · KYG
Ameritek, Inc.
Ophthalmic · 13d
Cleared Mar 28, 1986
HV-4
K853154 · IPF
Robert Bosch Corp.
Physical Medicine · 242d
Cleared Mar 28, 1986
SP 4
K853541
Robert Bosch Corp.
Physical Medicine · 214d
Cleared Mar 28, 1986
MODEL 20 PREVIOUSLY HAND-HELD CO2 LASER SYSTEM
K854386 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 148d
Cleared Mar 28, 1986
MIDIFICATION SYS*STIM 207 (MODEL-ME207)
K855249 · IPF
Mettler Electronics Corp.
Physical Medicine · 92d
Cleared Mar 28, 1986
SYS*STIM 206 (MODEL-ME 206)
K860107 · IPF
Mettler Electronics Corp.
Physical Medicine · 74d
Cleared Mar 28, 1986
ENZYMUN-TEST FERRITIN
K860137 · DBF
Boehringer Mannheim Corp.
Immunology · 73d
Cleared Mar 28, 1986
NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM
K860138 · DDB
Sigma Diagnostics, Inc.
Immunology · 73d
Cleared Mar 28, 1986
BRAWN AND GROSHONG CATHETERS
K860256 · FOZ
Catheter Technology Corp.
General Hospital · 63d
Cleared Mar 28, 1986
SAFE SUN 700 HOME TANNING UNIT
K860370 · FTC
Safe Sun Corporation of America, Inc.
General & Plastic Surgery · 53d
Cleared Mar 28, 1986
OSTEO-MESH CRANIAL FAIRING
K860491
Xomed, Inc.
General & Plastic Surgery · 46d
Cleared Mar 28, 1986
BIOGRAM APO A1/B
K860629 · MSJ
Bio-Rad
Immunology · 37d
Cleared Mar 28, 1986
SS-A/SS-B AUTOANTIBODY TEST SYSTEM
K860644 · LLL
Immuno Concepts, Inc.
Immunology · 36d
Cleared Mar 28, 1986
90 DEGREE ELBOW & STRAIGHT CONNECTOR
K860650 · BZA
Intertech/Ohio
Anesthesiology · 35d
Cleared Mar 28, 1986
CHICK SURIGICAL LIGHT
K860739 · FSY
Professional Medical Products, Inc.
General & Plastic Surgery · 29d
Cleared Mar 28, 1986
GROSSE AND KEMPF LOCKING NAIL SYSTEM, NON-SLOT ROD
K860756 · HSB
Howmedica Corp.
Orthopedic · 28d
Cleared Mar 28, 1986
RADTECH VASCULAR STENT
K860763
Radtech, Inc.
General & Plastic Surgery · 25d
Cleared Mar 28, 1986
ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM
K860851 · DGO
Nichols Institute Diagnostics
Immunology · 21d
Cleared Mar 28, 1986
SAPPHIRE BLADE SURGICAL KNIFE
K860852 · HNN
Med-Tech Develoment Corp.
Ophthalmic · 21d