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
75793–75816 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2002
CANDELA VBEAM PULSED DYE LASER SYSTEM
K021180 · GEX
Candela Corp.
General & Plastic Surgery · 78d
Cleared Jul 02, 2002
SCEPTRE-VS
K021314 · LLZ
Hitachi Medical Systems America, Inc.
Radiology · 68d
Cleared Jul 02, 2002
XIVE DENTAL IMPLANT SYSTEM
K021318 · DZE
Friadent GmbH
Dental · 68d
Cleared Jul 02, 2002
STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX
K021346 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Jul 02, 2002
AART CHIN IMPLANT
K021417 · FWP
Aesthetic and Reconstructive...
General & Plastic Surgery · 60d
Cleared Jul 02, 2002
AART NASAL IMPLANT
K021418 · FZE
Aesthetic and Reconstructive...
General & Plastic Surgery · 60d
Cleared Jul 02, 2002
AART MALAR IMPLANT
K021419 · LZK
Aesthetic and Reconstructive...
General & Plastic Surgery · 60d
Cleared Jul 02, 2002
STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN...
K021521 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 53d
Cleared Jul 02, 2002
IQ NASAL MASK, MODEL 50160 REV. D
K021534 · BZD
Sleepnet Corporation
Anesthesiology · 53d
Cleared Jul 02, 2002
INFINITI
K021566 · HQC
Alcon Laboratories, Inc.
Ophthalmic · 50d
Cleared Jul 02, 2002
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS...
K021824 · FGE
Guidant Corp.
Gastroenterology & Urology · 28d
Cleared Jul 02, 2002
MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM
K021829 · MQB
Eastman Kodak Company
Radiology · 28d
Cleared Jul 02, 2002
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
K021830 · DTR
Cobe Cardiovascular, Inc.
Cardiovascular · 28d
Cleared Jul 02, 2002
TRIDENT CROSSFIRE POLYUETHYLENE LINERS
K021911 · LPH
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jul 02, 2002
SAMPLOK LUER KIT
K021941 · JKA
Itl Corporation Pty, Ltd.
Chemistry · 19d
Cleared Jul 02, 2002
POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
K021961 · LYZ
Copioumed Intl., Inc.
General Hospital · 18d
Cleared Jul 02, 2002
Q LAB SOFTWARE
K021966 · LLZ
Advanced Technology Laboratories, Inc.
Radiology · 15d
Cleared Jul 02, 2002
PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM
K021984 · IYN
Inceptio Medical Technologies, LC
Radiology · 14d
Cleared Jul 02, 2002
JUSTWO MODEL TME-601 ROOT APEX LOCATOR
K022020 · LQY
Toei Electric Co., Ltd.
Dental · 12d
Cleared Jul 01, 2002
VERTEBRAL SPACER
K011037 · MQP
Synthes (Usa)
Orthopedic · 452d
Cleared Jul 01, 2002
LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE
K011220 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 437d
Cleared Jul 01, 2002
BIOTOUCH MASSAGE THERAPY SYSTEM
K013061 · IRP
Tactile Systems Technology, Inc.
Physical Medicine · 293d
Cleared Jul 01, 2002
TRIPLE LUMEN CENTRAL VENOUS CATHETER
K013182 · FOZ
Cook, Inc.
General Hospital · 280d
Cleared Jul 01, 2002
CARESIDE GGT
K020486 · JPZ
Careside, Inc.
Chemistry · 138d