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
94849–94872 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 23, 1997
TONY RISO 25/30 MULTIFUNCTION SCALER
K964320 · ELC
Tony Riso Co., Inc.
Dental · 86d
Cleared Jan 23, 1997
VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM
K964402 · GZT
V. Mueller Neuro/Spine
Neurology · 80d
Cleared Jan 22, 1997
SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY
K954717 · HBB
Sodem Diffusion SA
Neurology · 467d
Cleared Jan 22, 1997
BRENTWOOD PC-ECG
K955023 · DSI
Brentwood Medical Products, Inc.
Cardiovascular · 447d
Cleared Jan 22, 1997
DIASONICS ITNRAOPERATIVE PROBES
K961002 · ITX
Diasonics Ultrasound
Radiology · 316d
Cleared Jan 22, 1997
HEMASHIELD VANTAGE (VASCULAR GRAFT
K961847 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 254d
Cleared Jan 22, 1997
MEDOFF SLIDING PLATE (PROPOSED NAME)
K962251 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 224d
Cleared Jan 22, 1997
RICHARDS TOTAL/PARTIAL PROSTHESIS
K962564 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 205d
Cleared Jan 22, 1997
COAG-A-MATE MTX
K962857 · GKP
Organon Teknika Corp.
Hematology · 184d