FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
74881–74904 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2002
HERPESELECT 2 ELISA IGG, MODEL ELO920G
K021486 · MXJ
Focus Technologies, Inc.
Microbiology · 90d
Cleared Aug 01, 2002
UNINHIBITED
K021503 · EBD
Bisco, Inc.
Dental · 84d
Cleared Aug 01, 2002
PLUS PIVOT LINK UNIVERSAL SYSTEM
K021507 · KWP
Spine Vision, Inc.
Orthopedic · 84d
Cleared Aug 01, 2002
UNI-T UNI-THREAD SPINAL SYSTEM
K021510 · MNI
Spine Vision, Inc.
Orthopedic · 84d
Cleared Aug 01, 2002
RUSCH EDGAR TUBE
K021540 · BTR
Rusch Intl.
Anesthesiology · 83d
Cleared Aug 01, 2002
CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM
K021549 · KXA
Std Mfg., Inc.
Orthopedic · 80d
Cleared Aug 01, 2002
DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR, POWDER FREE WITH VITAMIN E
K021853 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 56d
Cleared Aug 01, 2002
TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES
K021950 · LYY
Top Glove Medical (Thailand) Co., Ltd.
General Hospital · 49d
Cleared Aug 01, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML
K021954 · LON
Becton, Dickinson & CO
Microbiology · 48d
Cleared Aug 01, 2002
CERALOY
K021971 · EJH
Neirynck & Vogt NV
Dental · 45d
Cleared Aug 01, 2002
ESCAPE CONTROL MODULE
K021995 · ITI
Specialty Drives Technologies, Inc.
Physical Medicine · 44d
Cleared Aug 01, 2002
PERIFIX CATHETER CONNECTOR
K022019 · BSO
B.Braun Medical, Inc.
Anesthesiology · 42d
Cleared Aug 01, 2002
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN)
K022024 · LZA
Best Manufacturing Company
General Hospital · 42d
Cleared Aug 01, 2002
XIA SPINAL SYSTEM
K022160 · MNI
Howmedica Osteonics
Orthopedic · 29d
Cleared Aug 01, 2002
STRYKER T4 URETHANE HOOD
K022162 · FYA
Stryker Instruments
General Hospital · 29d
Cleared Aug 01, 2002
ENVOY
K022168 · DQA
Mennen Medical , Ltd.
Anesthesiology · 29d
Cleared Aug 01, 2002
DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N
K022193 · DQA
Ge Medical Systems Information...
Anesthesiology · 27d
Cleared Aug 01, 2002
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
K022203 · MEA
Abbott Laboratories
General Hospital · 27d
Cleared Aug 01, 2002
CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3
K022232 · JJX
Cliniqa Corporation
Chemistry · 22d
Cleared Aug 01, 2002
ADVANTAGE WINDOWS X-RAY/MR FUSION
K022310 · LLZ
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Jul 31, 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K012688 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 351d
Cleared Jul 31, 2002
POLAR WAND
K021387 · GEH
Chek-Med Systems
General & Plastic Surgery · 90d
Cleared Jul 30, 2002
PANAG
K011891 · GZJ
Panag International
Neurology · 407d
Cleared Jul 30, 2002
TRACH VOX
K013728 · JOH
Engineered Medical Systems
Anesthesiology · 263d