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.

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

Filters: Cleared only ×
175,230 results
33985–34008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 2015
Neodent Implant System
K150367 · NHA
Jjgc Industria E Comercio DE...
Dental · 151d
Cleared Jul 13, 2015
ArgenZ Esthetic Plus
K150919 · EIH
The Argen Corporation
Dental · 98d
Cleared Jul 13, 2015
Aura DR 43C-AG flat panel detector
K151014 · MQB
Abyzr Co., Ltd.
Radiology · 88d
Cleared Jul 13, 2015
Vitrea Software Toshiba Package, VSTP-001A
K151091 · LLZ
Toshibamedical Systems Corporation
Radiology · 81d
Cleared Jul 11, 2015
Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation...
K142468 · DSH
Cardiac Insight, Inc.
Cardiovascular · 311d
Cleared Jul 10, 2015
SpineFab Vertebral Body Replacement (VBR) System
K142005 · MQP
Oxford Performance Materials
Orthopedic · 352d
Cleared Jul 10, 2015
INOmax DSIR Plus MRI
K143213 · MRN
Ino Therapeutics/Ikaria
Anesthesiology · 242d
Cleared Jul 10, 2015
IOLMaster700
K143275 · HJO
Carl Zeiss Meditec, Inc.
Ophthalmic · 238d
Cleared Jul 10, 2015
SIGNA Pioneer
K143345 · LNH
Ge Healthcare Japan Corporation
Radiology · 231d
Cleared Jul 10, 2015
The Simple Locking IntraMedullary (SLIM) System
K143355 · HSB
Pega Medical, Inc.
Orthopedic · 228d
Cleared Jul 10, 2015
Aeroneb USB Contoller System
K143719 · CAF
Aerogen Limited
Anesthesiology · 193d
Cleared Jul 10, 2015
CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear,...
K150590 · LPL
Contamac, Ltd.
Ophthalmic · 123d
Cleared Jul 10, 2015
Atrax Anterior Cervical Plating System
K150834 · KWQ
X-Spine Systems, Inc.
Orthopedic · 102d
Cleared Jul 10, 2015
Houva-NET Control System
K150912 · FTC
National Biological Corporation
General & Plastic Surgery · 98d
Cleared Jul 10, 2015
HARMONIC Focus Long Shears + Adaptive Tissue Technology
K151340 · LFL
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 52d
Cleared Jul 10, 2015
Abbott ARCHITECT Total T4 Calibrators
K151566 · JIT
Abbott Laboratories
Chemistry · 30d
Cleared Jul 10, 2015
Penumbra Smart Coil
K151572 · HCG
Penumbra, Inc.
Neurology · 29d
Cleared Jul 09, 2015
VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M,...
K141133 · LYR
BIOMERIEUX
Microbiology · 434d
Cleared Jul 09, 2015
BONGOLD BONE GRAFT MATERIAL
K141725 · MQV
Beijing Allgens Medical Science &...
Orthopedic · 378d
Cleared Jul 09, 2015
KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
K142764 · CBP
Hangzhou Jinlin Medical Appliances...
Anesthesiology · 287d
Cleared Jul 09, 2015
Model BT-220L and BT-220C
K142799 · HGM
Bistos Co., Ltd.
Obstetrics & Gynecology · 283d
Cleared Jul 09, 2015
Powder Free Vinyl Patient Examination Gloves, Yellow Color
K143340 · LYZ
Zibo Ling Yun Medical Products Co, Ltd.
General Hospital · 230d
Cleared Jul 09, 2015
StarCeram® Z-Nature, StarCeram® Z-Smile
K143656 · EIH
H.C. Starck Ceramics GmbH
Dental · 198d
Cleared Jul 09, 2015
Ablation Confirmation
K150313 · LLZ
Neuwave Medical, Inc.
Radiology · 150d