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
75193–75216 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2002
IQ NASAL MASK, MODEL 50160 REV. D
K021534 · BZD
Sleepnet Corporation
Anesthesiology · 53d
Cleared Jul 02, 2002
INFINITI
K021566 · HQC
Alcon Laboratories, Inc.
Ophthalmic · 50d
Cleared Jul 02, 2002
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS...
K021824 · FGE
Guidant Corp.
Gastroenterology & Urology · 28d
Cleared Jul 02, 2002
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
K021829 · MQB
Eastman Kodak Company
Radiology · 28d
Cleared Jul 02, 2002
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
K021830 · DTR
Cobe Cardiovascular, Inc.
Cardiovascular · 28d
Cleared Jul 02, 2002
TRIDENT CROSSFIRE POLYUETHYLENE LINERS
K021911 · LPH
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jul 02, 2002
SAMPLOK LUER KIT
K021941 · JKA
Itl Corporation Pty, Ltd.
Chemistry · 19d
Cleared Jul 02, 2002
POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
K021961 · LYZ
Copioumed Intl., Inc.
General Hospital · 18d
Cleared Jul 02, 2002
Q LAB SOFTWARE
K021966 · LLZ
Advanced Technology Laboratories, Inc.
Radiology · 15d
Cleared Jul 02, 2002
PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM
K021984 · IYN
Inceptio Medical Technologies, LC
Radiology · 14d
Cleared Jul 02, 2002
JUSTWO MODEL TME-601 ROOT APEX LOCATOR
K022020 · LQY
Toei Electric Co., Ltd.
Dental · 12d
Cleared Jul 01, 2002
VERTEBRAL SPACER
K011037 · MQP
Synthes (Usa)
Orthopedic · 452d
Cleared Jul 01, 2002
LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE
K011220 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 437d
Cleared Jul 01, 2002
BIOTOUCH MASSAGE THERAPY SYSTEM
K013061 · IRP
Tactile Systems Technology, Inc.
Physical Medicine · 293d
Cleared Jul 01, 2002
TRIPLE LUMEN CENTRAL VENOUS CATHETER
K013182 · FOZ
Cook, Inc.
General Hospital · 280d
Cleared Jul 01, 2002
CARESIDE GGT
K020486 · JPZ
Careside, Inc.
Chemistry · 138d
Cleared Jul 01, 2002
RUSCH FLONEIL
K020714 · GBM
Rusch Intl.
Gastroenterology & Urology · 118d
Cleared Jul 01, 2002
GREAT TOE IMPLANT
K021063 · KWD
Signal Medical Corp.
Orthopedic · 90d
Cleared Jul 01, 2002
PCCS GRAFT DELIVERY SYSTEM
K021071 · FMF
Biomet, Inc.
General Hospital · 90d
Cleared Jul 01, 2002
ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX
K021079 · GEI
Conmedcorp
General & Plastic Surgery · 89d
Cleared Jul 01, 2002
MACROPORE OS TRAUMA
K021164 · HRS
Macropore Biosurgery, Inc.
Orthopedic · 81d
Cleared Jul 01, 2002
NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES
K021165 · IPL
Bromac Assistive Technology
Physical Medicine · 81d
Cleared Jul 01, 2002
NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735
K021196 · JXG
Neuron Therapeutics, Inc.
Neurology · 76d
Cleared Jul 01, 2002
O&P CRANICAL MOLDING HELMET
K021221 · MVA
Orthotic & Prosthetic Lab, Inc.
Neurology · 75d