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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
108001–108024 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 1994
SKI VECTOR NON-PRESCRIPTION SUNGLASSES
K940831 · HQY
Mountain Shades, Inc.
Ophthalmic · 101d
Cleared Jun 03, 1994
SUNGLASSES (NON-PRESCRIPTION)
K940850 · HQY
Fantasia Novelty Ent. Corp.
Ophthalmic · 100d
Cleared Jun 03, 1994
MODEL 900GE1500 HEAD/NECK COIL
K940874 · LNH
Medic, Inc.
Radiology · 98d
Cleared Jun 03, 1994
CROWN,SKI OPTIC SUNGLASSES
K940947 · HQY
Sunglass Experts
Ophthalmic · 95d
Cleared Jun 03, 1994
ASSURE URINE HCG CONTROL
K941130 · JJX
Quantimetrix Corp.
Chemistry · 86d
Cleared Jun 03, 1994
DUPONT ACA PLUS PROLACTIN (PROL) METHOD
K941220 · CFT
Dupont Medical Products
Chemistry · 81d
Cleared Jun 03, 1994
SUNGLASSES
K941296 · HQY
Three Leaves Industrial Co., Ltd.
Ophthalmic · 78d
Cleared Jun 03, 1994
STAT FAX 2600
K941394 · JQW
Awareness Technology, Inc.
Chemistry · 73d
Cleared Jun 03, 1994
SPECTACLE FRAMES/SUNGLASSES
K941576 · HQY
Sanders Optical Co., Inc.
Ophthalmic · 64d
Cleared Jun 03, 1994
SPECTACLE FRAMES
K941602 · HQZ
Slim Occhiali
Ophthalmic · 63d
Cleared Jun 03, 1994
SURGICAL SPONGE
K941649 · EFQ
Industries For the Blind & Visually...
General & Plastic Surgery · 59d
Cleared Jun 03, 1994
SUNGLASSES
K941751 · HQY
The Orvis Co., Inc.
Ophthalmic · 56d
Cleared Jun 03, 1994
FRAMES - VARIOUS BRAND NAMES
K941767 · HQZ
Lenscraft, Inc.
Ophthalmic · 53d
Cleared Jun 03, 1994
SUNGLASSES
K941873 · HQY
Koadak Optical Industrial Co., Ltd.
Ophthalmic · 46d
Cleared Jun 03, 1994
SUNGLASSES
K941875 · HQY
The Limited Stores, Inc.
Ophthalmic · 46d
Cleared Jun 03, 1994
R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502
K942034 · HLJ
R & D Batteries, Inc.
Ophthalmic · 36d
Cleared Jun 03, 1994
I.V. STARTPAK VASCULAR ACCESS START KIT
K942238 · LRS
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 25d
Cleared Jun 03, 1994
SUNGLASSES
K942375 · HQY
Kool World, Inc.
Ophthalmic · 16d
Cleared Jun 02, 1994
BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE
K922481 · JOJ
Board of Directors, Albert Browne , Ltd.
General Hospital · 737d
Cleared Jun 02, 1994
WAVICIDE MONITOR STRIPS
K932047 · MED
Serim Research Corp.
General Hospital · 401d
Cleared Jun 02, 1994
APOLIPOPROTIEN B (APO B)
K932603 · JHN
Sigma Diagnostics, Inc.
Chemistry · 370d
Cleared Jun 02, 1994
APOLIPOPROTIEN A-1 (APO A-1)
K932606 · JHN
Sigma Diagnostics, Inc.
Chemistry · 370d
Cleared Jun 02, 1994
SOFAMOR ORFIL SPINE FIXATION SYSTEM
K934007 · KWP
Sofamor Co.
Orthopedic · 288d
Cleared Jun 02, 1994
WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION
K934116 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 281d