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
95353–95376 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1997
TAP
K964516 · LRK
Nellcor Puritan Bennett, Inc.
Dental · 80d
Cleared Jan 24, 1997
PROFILE 70000 QUADRATURE VOLUME NECK COIL
K964531 · LNH
Us Asia Instruments, Inc.
Radiology · 73d
Cleared Jan 24, 1997
BONESOURCE HYDROXYAPATITE CEMENT (HAC)
K964537 · GXP
Osteogenics, Inc.
Neurology · 73d
Cleared Jan 24, 1997
INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL...
K964577 · KPI
Empi
Gastroenterology & Urology · 71d
Cleared Jan 24, 1997
VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE
K964649 · JEY
Howmedica Leibinger, Inc.
Dental · 65d
Cleared Jan 24, 1997
COMFORTAID HEARING AID
K964680 · ESD
Ethical Hearing Instruments
Ear, Nose, Throat · 63d
Cleared Jan 24, 1997
ELECSYS LH ASSAY
K964694 · CEP
Boehringer Mannheim Corp.
Chemistry · 63d
Cleared Jan 24, 1997
DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM
K964704 · LZO
Depuy, Inc.
Orthopedic · 60d
Cleared Jan 24, 1997
HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION
K964746 · JAK
GE Medical Systems
Radiology · 59d
Cleared Jan 24, 1997
OPUS BONE ALP
K964764 · CIN
Behring Diagnostics, Inc.
Chemistry · 58d
Cleared Jan 24, 1997
DERLIN
K964817 · LYY
Derlin Company , Ltd.
General Hospital · 56d
Cleared Jan 24, 1997
A LITHOTRIPTER-COMPATIBLE BASKET
K964937 · LQC
Boston Scientific Corp
Gastroenterology & Urology · 45d
Cleared Jan 24, 1997
PENCIL
K965054 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 37d
Cleared Jan 24, 1997
M11 SERIES: M11, M11M
K965088 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 36d
Cleared Jan 24, 1997
ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES
K965156 · KWL
Johnson & Johnson Professionals, Inc.
Orthopedic · 32d
Cleared Jan 24, 1997
SENSO DIGITAL (C18)
K965218 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 25d
Cleared Jan 24, 1997
ABBOTT ADVISOR ONE-STEP PREGNANCY TEST
K970082 · LCX
Abbott Laboratories
Chemistry · 15d
Cleared Jan 23, 1997
FIRST TOUCH DISPOSABLES TEMPERATURE PROBES
K950422 · FMT
First Touch Disposables, Inc.
General Hospital · 721d
Cleared Jan 23, 1997
PERCUPUMP II WITH EDA
K961845 · DSB
E-Z-Em, Inc.
Radiology · 255d
Cleared Jan 23, 1997
SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
K962492 · BYE
Nidek Medical Products, Inc.
Anesthesiology · 211d
Cleared Jan 23, 1997
SILENT NIGHT I
K963597 · MNR
Local Silence, Inc.
Anesthesiology · 136d
Cleared Jan 23, 1997
TILTING RADIOGRAPHIC TABLE (REMOTE)
K963851 · IXR
Acoma Medical Imaging, Inc.
Radiology · 120d
Cleared Jan 23, 1997
OLYMPUS CRITICAL CARE MONITORING SYSTEM
K963935 · CCC
Optical Sensors, Inc.
Anesthesiology · 114d
Cleared Jan 23, 1997
PERFORMR SERIES EP DIAGNOSTIC CATHETERS
K964272 · DRF
Medtronic Cardiorhythm
Cardiovascular · 90d