FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76537–76560 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 2002
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
K020196 · MNH
Sulzer Spine-Tech
Orthopedic · 24d
Cleared Feb 15, 2002
A1CNOW FOR RX HOME USE
K020234 · LCP
Metrika, Inc.
Hematology · 23d
Cleared Feb 15, 2002
A1CNOW FOR PROFESSIONAL USE
K020235 · LCP
Metrika, Inc.
Hematology · 23d
Cleared Feb 15, 2002
PARAGON INFUSION SYSTEM
K020251 · FRN
I-Flow Corp.
General Hospital · 22d
Cleared Feb 15, 2002
CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A
K020385 · JAK
Toshiba America Medical Systems, In.C
Radiology · 10d
Cleared Feb 14, 2002
GINDA GUARD
K011239 · EBD
Cosmedent, Inc.
Dental · 297d
Cleared Feb 14, 2002
REPROCESSED STONE RETRIEVAL BASKETS
K012581 · FFL
Sterilmed, Inc.
Gastroenterology & Urology · 189d
Cleared Feb 14, 2002
REPROCESSED ENDOSCOPIC ELECTRODES
K012685 · NLW
Sterilmed, Inc.
Gastroenterology & Urology · 184d
Cleared Feb 14, 2002
DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)
K013542 · KLE
Jeneric/Pentron, Inc.
Dental · 120d
Cleared Feb 14, 2002
MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN...
K014036 · MDA
Medtrade Products , Ltd.
General & Plastic Surgery · 69d
Cleared Feb 14, 2002
PROMOGRAN MATRIX WOUND DRESSING
K014129 · KGN
Johnson & Johnson Medical, Ltd.
General & Plastic Surgery · 59d
Cleared Feb 14, 2002
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE
K014285 · LZA
Formosa Glove Industrial Co., Ltd.
General Hospital · 49d
Cleared Feb 14, 2002
ENAMEL BONDING SYSTEM
K020050 · KLE
Rite-Dent Manufacturing Corp.
Dental · 38d
Cleared Feb 14, 2002
XERAFIT
K020062 · EJH
Metalor Technologies USA
Dental · 37d
Cleared Feb 14, 2002
SMARTFLOW PULSE TRANSMISSION COEFFICIENT
K020127 · DQK
Florence Medical , Ltd.
Cardiovascular · 30d
Cleared Feb 14, 2002
MODIFICATION TO PASS SPINAL SYSTEM
K020236 · KWP
Encore Orthopedics, Inc.
Orthopedic · 22d
Cleared Feb 14, 2002
OSTEONICS SPINAL SYSTEM
K020293 · MNH
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Feb 14, 2002
DISPOSABLE LIGHT HANDLE AND ADAPTOR
K020304 · FTA
Aspen Surgical Products, Inc.
General & Plastic Surgery · 16d
Cleared Feb 14, 2002
NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER...
K020317 · LZA
Sgmp Co., Ltd.
General Hospital · 15d
Cleared Feb 13, 2002
UNI-T SPINAL SYSTEM
K013301 · MNI
Spine Vision, Inc.
Orthopedic · 133d
Cleared Feb 13, 2002
P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)
K013312 · KWP
Spine Vision, Inc.
Orthopedic · 132d
Cleared Feb 13, 2002
FLOWGUARD DEVICE
K013803 · DPW
Biosonix , Ltd.
Cardiovascular · 90d
Cleared Feb 13, 2002
SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM
K013979 · KWQ
Spinal Concepts, Inc.
Orthopedic · 72d
Cleared Feb 13, 2002
POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES
K013998 · LZA
Sheen More Ent. Co., Ltd.
General Hospital · 71d