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
105265–105288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 1994
PRO-TEC DISPOSBLE SHARPS CONTAINERS Q1
K945275 · FMI
Pro-Tec Containers, Inc.
General Hospital · 47d
Cleared Dec 14, 1994
PRO-TEC DISPOSABLE SHARPS CONTAINERS 5G
K945276 · FMI
Pro-Tec Containers, Inc.
General Hospital · 47d
Cleared Dec 14, 1994
PHILIPS BUCKY DIAGNOST FAMILY
K945278 · KPR
Philips Medical Systems North...
Radiology · 47d
Cleared Dec 14, 1994
SII 360 MS
K945708 · KPR
Scott Imaging Intl., Inc.
Radiology · 23d
Cleared Dec 14, 1994
SII 525 MS
K945709 · KPR
Scott Imaging Intl., Inc.
Radiology · 23d
Cleared Dec 13, 1994
POWDERFREE LATEX EXAMINATION GLOVES
K932521 · LYY
Top Glove Sdn. Bhd.
General Hospital · 567d
Cleared Dec 13, 1994
ANGIOGRAPHY SYRINGE KITS
K933846 · DXT
Angiodynamics, Div. E-Z-Em, Inc.
Cardiovascular · 494d
Cleared Dec 13, 1994
MODEL 3471 CLINICAL REFRACTOMETER
K941902 · JRE
Vee Gee Scientific, Inc.
Chemistry · 238d
Cleared Dec 13, 1994
MODEL A300CL CLINICAL REFRACTOMETER
K941904 · JRE
Vee Gee Scientific, Inc.
Chemistry · 238d
Cleared Dec 13, 1994
MODEL 3461 CLINICAL REFRACTOMETER
K941905 · JRE
Vee Gee Scientific, Inc.
Chemistry · 238d
Cleared Dec 13, 1994
HIGH PRESSURE TUBING
K941978 · DQO
Abbott Laboratories
Cardiovascular · 243d
Cleared Dec 13, 1994
WGL ENDOSCOPIC GRASPER
K942168 · GCJ
Wilson Greatbatch Technologies, Inc.
General & Plastic Surgery · 223d
Cleared Dec 13, 1994
LIHTAN 4100 KRYPTON
K942729 · GEX
Lihtan Technologies, Inc.
General & Plastic Surgery · 187d
Cleared Dec 13, 1994
ALBUMIN QVET
K943000 · CIX
Prisma Systems
Chemistry · 173d
Cleared Dec 13, 1994
UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED
K943045 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 169d
Cleared Dec 13, 1994
AST QVET
K944102 · CIT
Prisma Systems
Chemistry · 112d
Cleared Dec 13, 1994
IV ADMINISTRATION SET FPA
K944208 · FPA
Medex, Inc.
General Hospital · 106d
Cleared Dec 13, 1994
CONTOUR EMBOLI
K944354 · HCG
Interventional Therapeutics Corp.
Neurology · 105d
Cleared Dec 13, 1994
MODEL 5135 AUTO LP/FLASH
K944607 · GCT
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 85d
Cleared Dec 13, 1994
FAMILY FITNESS SHIATSU MASSAGER
K944637 · ISA
Conair Corp.
Physical Medicine · 83d
Cleared Dec 13, 1994
PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB...
K944762 · BZG
Puritan Bennett Corp.
Anesthesiology · 77d
Cleared Dec 13, 1994
SOLUTION
K944970 · IOR
Freedom Designs, Inc.
Physical Medicine · 63d
Cleared Dec 13, 1994
OPTUS THORACOSCOPES
K945263 · GCJ
Optus, Inc.
General & Plastic Surgery · 46d
Cleared Dec 13, 1994
DOA - IMMUNOASSAY CUT-OFF CALIBRATOR
K945289 · DKB
Medi-Tech, Inc.
Toxicology · 43d