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
95377–95400 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 22, 1997
SAFETY INJECTION SYSTEM
K962999 · EJI
Integritech, Inc.
Dental · 173d
Cleared Jan 22, 1997
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT...
K963263 · GKZ
Coulter Corp.
Hematology · 155d
Cleared Jan 22, 1997
SERAQUEST HSV IGG
K963282 · LGC
Quest Intl., Inc.
Microbiology · 154d
Cleared Jan 22, 1997
STRYKER TEMPEST ORTHOPEDIC PUMP
K963304 · HRX
Stryker Endoscopy
Orthopedic · 153d
Cleared Jan 22, 1997
OLYMPUS,JASMINE,JIMMY-O...
K963319 · HIS
Custom Services Intl., Inc.
Obstetrics & Gynecology · 163d
Cleared Jan 22, 1997
OLYMPUS,JASMINE,JIMMY-O...
K963321 · HIS
Custom Services Intl., Inc.
Obstetrics & Gynecology · 163d
Cleared Jan 22, 1997
OLYMPUS,JASMINE,JIMMY-O...
K963322 · LTZ
Custom Services Intl., Inc.
Obstetrics & Gynecology · 163d
Cleared Jan 22, 1997
COHERENT ULTRAPULSE CO2 SURGICAL LASERS
K963339 · GEX
Coherent Medical Group
General & Plastic Surgery · 149d
Cleared Jan 22, 1997
CO 2 SMO PLUS
K963380 · BZC
Novametrix Medical Systems, Inc.
Anesthesiology · 148d
Cleared Jan 22, 1997
RESTRICTIVE LIMB HOLDER
K963468 · FMQ
Deroyal Industries, Inc.
General Hospital · 141d
Cleared Jan 22, 1997
TUXEDO VEST RESTRAINT
K963474 · FMQ
Deroyal Industries, Inc.
General Hospital · 141d
Cleared Jan 22, 1997
PONCHO VEST RESTRAINT
K963475 · KID
Deroyal Industries, Inc.
Physical Medicine · 141d
Cleared Jan 22, 1997
DISPOSABLE LIMB HOLDER
K963476 · FMQ
Deroyal Industries, Inc.
General Hospital · 141d
Cleared Jan 22, 1997
MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER
K963480 · KID
Deroyal Industries, Inc.
Physical Medicine · 141d
Cleared Jan 22, 1997
DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED
K963548 · EIA
Mrlb Intl., Inc.
Dental · 139d