FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

Filters: Cleared only ×
175,820 results
108841–108864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 1994
NON-PRESCRIPTION SUNGLASSES
K941432 · HQY
Large River Industrial Co., Ltd.
Ophthalmic · 74d
Cleared Jun 06, 1994
DUPONT CRONEX PORTABLE GRID CASSETTE
K941518 · IXA
Dupont Medical Products
Radiology · 68d
Cleared Jun 06, 1994
WEIGHT BAG
K941592 · KPR
Biocor, Inc.
Radiology · 67d
Cleared Jun 06, 1994
UCL MULTIFOCAL SOFT CONTACT LENS
K941607 · LPL
United Contact Lens, Inc.
Ophthalmic · 67d
Cleared Jun 06, 1994
CHILDREN'S SUNGLASSES
K941687 · HQY
Merchandising/Imports
Ophthalmic · 61d
Cleared Jun 06, 1994
WELCH ALLYN GLAUCOMA DETECTOR
K941723 · HOO
Welch Allyn, Inc.
Ophthalmic · 60d
Cleared Jun 06, 1994
DISPOSABLE ENT PUNCH
K942065 · LRC
United States Surgical, A Division of...
Ear, Nose, Throat · 38d
Cleared Jun 06, 1994
SUNGLASSES
K942237 · HQY
Sun Wellen, Inc.
Ophthalmic · 28d
Cleared Jun 06, 1994
AXT 1400 SPOTFILM DEVICE
K942367 · IXL
Applied X-Ray Technologies, Inc.
Radiology · 19d
Cleared Jun 06, 1994
AMCON SLIP IN MYDRIATIC SUNGLASSES
K942407 · HOY
Amcon Laboratories, Inc.
Ophthalmic · 17d
Cleared Jun 03, 1994
EUB-555
K926209 · IYO
Hitachi Medical Corp.
Radiology · 541d
Cleared Jun 03, 1994
TN-RD-50
K932598 · IYE
Keithley Instruments, Inc.
Radiology · 371d
Cleared Jun 03, 1994
SUPRA-VIT(TM)
K932669 · HQE
Medical Instrument Development...
Ophthalmic · 366d
Cleared Jun 03, 1994
LACEY ALL POLYETHYLENE TIBIAL COMPONENT
K934354 · JWH
Dow Corning Wright
Orthopedic · 269d
Cleared Jun 03, 1994
COATED ZT PROXIMAL SLEEVE
K934412 · LPH
Joint Medical Products Corp.
Orthopedic · 266d
Cleared Jun 03, 1994
SUNGLASSES
K934576 · HQY
Guide Firm , Ltd.
Ophthalmic · 262d
Cleared Jun 03, 1994
TI-FRAME
K934860 · KWP
Johnson & Johnson Professionals, Inc.
Orthopedic · 234d
Cleared Jun 03, 1994
P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA
K935262 · JWH
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 212d
Cleared Jun 03, 1994
BE-SAFE
K935843 · FMI
Mathis-Koolpe, Inc.
General Hospital · 177d
Cleared Jun 03, 1994
FOUNDATION POROUS ACETABULAR COMPONENT
K936043 · JDI
Encore Orthopedics, Inc.
Orthopedic · 165d
Cleared Jun 03, 1994
KIT,I.V. START
K940035 · LYZ
Mason-Keller Corp.
General Hospital · 150d
Cleared Jun 03, 1994
ARTHROSCOPE
K940090 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 147d
Cleared Jun 03, 1994
EDTA GEL (TM)
K940737 · EBF
Karolinska Institutet
Dental · 106d
Cleared Jun 03, 1994
SKI VECTOR NON PRECRIPTION SUNGLASSES
K940740 · HQY
Mountain Shades, Inc.
Ophthalmic · 106d