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
93025–93048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 1997
SVL-9130 DEFIBRILLATION ELECTRODE
K971149 · MKJ
Survivalink Corp.
Cardiovascular · 87d
Cleared Jun 22, 1997
PRIMED PRIME-PLUS COTTON GAUZE SPONGES
K971075 · EFQ
Primeline Medical Products, Inc.
General & Plastic Surgery · 90d
Cleared Jun 20, 1997
SYNAPTIC 3000
K940954 · GZJ
The Synaptic Corp.
Neurology · 1207d
Cleared Jun 20, 1997
PRELOADED SOFT TISSUE ANCHOR
K963932 · MBI
Linvatec Corp.
Orthopedic · 262d
Cleared Jun 20, 1997
NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2
K964206 · IYE
Nucletron Corp.
Radiology · 242d
Cleared Jun 20, 1997
LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT
K964688 · FGE
Cordis Corp.
Gastroenterology & Urology · 210d
Cleared Jun 20, 1997
PHOTON RADIOSURGERY SYSTEM (PRS)
K964947 · JAD
Photoelectron Corporation
Radiology · 192d
Cleared Jun 20, 1997
TECA. MILLENNIUM
K965065 · GWF
Medelec , Ltd.
Neurology · 184d
Cleared Jun 20, 1997
BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH...
K970049 · ITX
Cardiovascular Imaging Systems, Inc.
Radiology · 165d
Cleared Jun 20, 1997
GENERAL PURPOSE TRANDUCER COVER
K970513 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 129d
Cleared Jun 20, 1997
DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT...
K970514 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 129d
Cleared Jun 20, 1997
GENERAL PURPOSE LATEX TRANSDUCER COVERS
K970515 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 129d
Cleared Jun 20, 1997
GLORY
K970680 · IZH
Elscint, Inc.
Radiology · 116d
Cleared Jun 20, 1997
ELECT II BLOOD GLUCOSE MONITORING SYSTEM
K970707 · CGA
Selfcare, Inc.
Chemistry · 114d
Cleared Jun 20, 1997
SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM
K970771 · BZD
Resmed, Ltd.
Anesthesiology · 109d
Cleared Jun 20, 1997
H.V. PULSE LAVAGE (L31 SERIES)
K970916 · FQH
Global Medical Products, Inc.
General Hospital · 100d
Cleared Jun 20, 1997
FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT
K971047 · KWD
Nexa Orthopedics, Inc.
Orthopedic · 91d
Cleared Jun 20, 1997
DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION
K971055 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Jun 20, 1997
CHOLESTEROL REAGENT
K971072 · CHH
Derma Media Lab., Inc.
Chemistry · 88d
Cleared Jun 20, 1997
BLINK EXTERNAL EYELID WEIGHT
K971245 · MML
Ipax, Inc.
Ophthalmic · 78d
Cleared Jun 20, 1997
LEO 7000 QUADRATURE KNEE COIL
K971246 · MOS
Usa Instruments, Inc.
Radiology · 78d
Cleared Jun 20, 1997
STRATASYS FDM MEDMODELER SYSTEM
K971290 · LLZ
Paladin Medical, Inc.
Radiology · 74d
Cleared Jun 20, 1997
TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A,...
K971296 · ESD
National Hearing Aid Dist., Inc.
Ear, Nose, Throat · 74d
Cleared Jun 20, 1997
TRIGLYCERIDES, TG, OR TRIG
K971324 · CDT
Carolina Liquid Chemistries Corp.
Chemistry · 71d