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
76033–76056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 13, 2002
HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE
K014073 · FMF
Portex, Inc.
General Hospital · 65d
Cleared Feb 13, 2002
ENDIUS CERVICAL PLATE SYSTEM
K014107 · KWQ
Endius, Inc.
Orthopedic · 62d
Cleared Feb 13, 2002
AOS CANNULATED BONE SCREW SYSTEM
K014185 · HWC
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 55d
Cleared Feb 13, 2002
DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH...
K014288 · KGO
Wrp Specialty Products Sdn. Bhd.
General Hospital · 47d
Cleared Feb 13, 2002
OMNIA X/XS ULTRASOUND SYSTEM
K020353 · IYN
Siemens Medical Systems, Inc.
Radiology · 9d
Cleared Feb 13, 2002
STERRAD CYCLESURE BIOLOGICAL INDICATOR
K994055 · FRC
Advanced Sterilization Products
General Hospital · 806d
Cleared Feb 12, 2002
BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T
K010452 · DPW
Koven Technology, Inc.
Cardiovascular · 362d
Cleared Feb 12, 2002
COBE REVOLUTION
K011835 · KFM
Cobe Cardiovascular, Inc.
Cardiovascular · 245d
Cleared Feb 12, 2002
SENSAID
K011974 · DQA
Sensidyne, Inc.
Anesthesiology · 232d