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
74665–74688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2002
SSIR SYSTEM
K014208 · ILY
Russian-American Technology...
Physical Medicine · 193d
Cleared Jul 02, 2002
DINAMAP PROCARE SERIES MONITOR
K014255 · MWI
Ge Medical Systems Information...
Cardiovascular · 188d
Cleared Jul 02, 2002
LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)
K020021 · GEX
Laserscope
General & Plastic Surgery · 180d
Cleared Jul 02, 2002
INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02
K020386 · CAW
Invacare Corp.
Anesthesiology · 146d
Cleared Jul 02, 2002
RESPERATE
K020399 · HCC
Intercure , Ltd.
Neurology · 146d
Cleared Jul 02, 2002
ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER
K021124 · IYE
Wfr/Aquaplast Corp.
Radiology · 85d
Cleared Jul 02, 2002
D/SENSE 1-STEP
K021146 · EJK
Centrix, Inc.
Dental · 84d
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