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
94993–95016 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 1997
MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE
K962001 · FMI
Manan Medical Products, Inc.
General Hospital · 233d
Cleared Jan 10, 1997
VOLMETRIC COINCIDENCE DETECTION SYSTEM
K962100 · KPS
Elscint, Inc.
Radiology · 225d
Cleared Jan 10, 1997
SMART ADJUSTER (SA201)
K962239 · LXM
Sigma
Physical Medicine · 213d
Cleared Jan 10, 1997
PIXELL MRI SYSTEM
K962249 · LNH
General Medical Equipment Corp.
Radiology · 213d
Cleared Jan 10, 1997
S3 CARDIOPLEGIA CONTROL
K962320 · DTR
Stoeckert Instrumente
Cardiovascular · 207d
Cleared Jan 10, 1997
SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR
K962683 · HIF
Deknatel, Inc.
Obstetrics & Gynecology · 184d
Cleared Jan 10, 1997
FOTONA SKINLIGHT LASER SYSTEM
K962902 · GEX
Medical Laser Solutions
General & Plastic Surgery · 169d
Cleared Jan 10, 1997
STERILE SOFT-TEMP
K962983 · ILO
Adroit Medical Systems, Inc.
Physical Medicine · 162d
Cleared Jan 10, 1997
ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
K962995 · EWO
Otodynamics, Ltd.
Ear, Nose, Throat · 162d
Cleared Jan 10, 1997
OPTICAL DIGITIZER OPTION FOR VIEW POINT
K963221 · HAW
Philips Medical Systems (Cleveland),...
Neurology · 147d
Cleared Jan 10, 1997
LUMEX AIR
K963674 · FNM
Lumex, Inc.
General Hospital · 119d
Cleared Jan 10, 1997
BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE
K963950 · EXI
Bioderm, Inc.
Gastroenterology & Urology · 100d
Cleared Jan 10, 1997
3050 SPORT-NEB
K964078 · CAF
Medical Industries America, Inc.
Anesthesiology · 91d
Cleared Jan 10, 1997
AEROGEAR ASTHMA ACTION KIT
K964130 · BZH
Monaghan Medical Corp.
Anesthesiology · 87d
Cleared Jan 10, 1997
HYSTERO CO2-PNEU 2221
K964136 · HIG
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 87d
Cleared Jan 10, 1997
VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE
K964138 · KPQ
Varian Medical Systems, Inc.
Radiology · 87d
Cleared Jan 10, 1997
WRITESTAR, AND VIEWSTAR
K964274 · LMB
Comview Corp.
Radiology · 77d
Cleared Jan 10, 1997
PHILIPS TOMOSCAN AV EXPANDER UPGRADE
K964318 · JAK
Philips Medical Systems North...
Radiology · 73d
Cleared Jan 10, 1997
MULTITAK SS SUTURE SYSTEM
K964324 · MBI
Bonutti Research
Orthopedic · 72d
Cleared Jan 10, 1997
PORTAREM-3000, PFS-6000
K964340 · EWO
Starkey Laboratories, Inc.
Ear, Nose, Throat · 71d
Cleared Jan 10, 1997
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K964370 · LNH
GE Medical Systems
Radiology · 70d
Cleared Jan 10, 1997
SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
K964450 · HET
Pilling Weck Group
Obstetrics & Gynecology · 65d
Cleared Jan 10, 1997
GIANNI VERSACE SUNGLASSES, VERSUS SUNGLASSES, DIABLO SUNGLASSES
K964505 · HQY
I C Optics, Ltd.
Ophthalmic · 63d
Cleared Jan 10, 1997
PROFILE MAMMOGRAPHY SYSTEM (M-PRO)
K964576 · IZH
Bennett X-Ray Corp.
Radiology · 57d