Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
70705–70728 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 02, 2003
CAP3 BONE SUBSTITUTE MATERIAL
K033138 · MQV
Etex Corp.
Orthopedic · 63d
Cleared Dec 02, 2003
LA500 BLUE LIGHT
K033201 · EBZ
Apoza Enterprise Co., Ltd.
Dental · 61d
Cleared Dec 02, 2003
PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS
K033246 · DLJ
Roche Diagnostics Corp.
Toxicology · 56d
Cleared Dec 02, 2003
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
K033387 · JJY
Bio-Rad
Chemistry · 40d
Cleared Dec 02, 2003
PFZ PORCELAIN SYSTEM
K033553 · EIH
Dentsply Intl.
Dental · 22d
Cleared Dec 01, 2003
MULTI-STRAP FULL FACE MASK
K023683 · BZD
Engineered Medical Systems
Anesthesiology · 395d
Cleared Dec 01, 2003
MICROLAB SPIROMETER
K031102 · BZG
Micro Direct, Inc.
Anesthesiology · 238d