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
69577–69600 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 2003
VECTRA (INTELECT) EPR ULTRASOUND
K031116 · IMI
Chattanooga Group
Physical Medicine · 239d
Cleared Dec 03, 2003
FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE
K031818 · MQX
Facilai Enterprises , Ltd.
General Hospital · 174d
Cleared Dec 03, 2003
A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT
K032572 · EBW
A-Dec, Inc.
Dental · 105d
Cleared Dec 03, 2003
PERMAQUICK SE BONDING SYSTEM
K032626 · KLE
Ultradent Products, Inc.
Dental · 99d
Cleared Dec 03, 2003
Z-SERIES MODULAR TOTAL HIP SYSTEM
K032729 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 91d
Cleared Dec 03, 2003
SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM
K032735 · GEX
Max Engineering , Ltd.
General & Plastic Surgery · 90d
Cleared Dec 03, 2003
R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM
K032752 · KWQ
R&B Surgical Solutions, LLC
Orthopedic · 89d
Cleared Dec 03, 2003
ELPHA 4 CONTI
K032988 · KPI
Danmeter A/S
Gastroenterology & Urology · 70d
Cleared Dec 03, 2003
9 SECOND DIGITAL THERMOMETER, MODEL BT-S09
K033082 · FLL
Metatech Co., Ltd.
General Hospital · 65d
Cleared Dec 03, 2003
ADVANTAGE PADDLE
K033202 · IZH
Livingston Products, Inc.
Radiology · 62d
Cleared Dec 03, 2003
MODIFICATION TO EQUATION FIXATION SYSTEM
K033495 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Dec 03, 2003
MODIFICATION TO TELEGRAPH HUMERAL NAIL
K033510 · HSB
Fournitures Hospitalieres Industrie
Orthopedic · 27d
Cleared Dec 03, 2003
DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS
K033516 · HSD
DePuy Orthopaedics, Inc.
Orthopedic · 26d
Cleared Dec 03, 2003
TIE-IN TRAPEZIUM
K033529 · KYI
Wrightmedicaltechnologyinc
Orthopedic · 23d
Cleared Dec 03, 2003
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K033635 · KTT
Ebi, L.P.
Orthopedic · 14d
Cleared Dec 02, 2003
SMITH & NEPHEW IUR MORCELLATION SYSTEM
K031787 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 175d
Cleared Dec 02, 2003
WU'S 3-WHEELED NEO SCOOTER, WT-T3D
K032488 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 112d
Cleared Dec 02, 2003
JUSTWIN SCOOTER, JS-3013
K032643 · INI
Joy Ride Tech Co., Ltd.
Physical Medicine · 97d
Cleared Dec 02, 2003
JUSTWIN SCOOTER, JS-3014
K032645 · INI
Joy Ride Tech Co., Ltd.
Physical Medicine · 97d
Cleared Dec 02, 2003
XIO RADIATION TREATMENT PLANNING SYSTEM
K032762 · IYE
Computerized Medical Systems, Inc.
Radiology · 88d
Cleared Dec 02, 2003
STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM
K032901 · GAT
Stryker Endoscopy
General & Plastic Surgery · 76d
Cleared Dec 02, 2003
TRSANSDERM IONTO SYSTEM
K032968 · EGJ
Mattioli Engineering Corp.
Physical Medicine · 70d
Cleared Dec 02, 2003
TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR
K033031 · IOR
Taiwan King Strong Co., Ltd.
Physical Medicine · 67d
Cleared Dec 02, 2003
TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01
K033100 · ITI
Taiwan King Strong Co., Ltd.
Physical Medicine · 64d