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
75481–75504 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2002
LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM
K020040 · LYY
Pt. Maja Agung Latexindo
General Hospital · 206d
Cleared Aug 01, 2002
NORMED BONE TRANSPORT DISTRACTION DEVICE
K021341 · JEY
Osteomedics, Inc.
Dental · 94d
Cleared Aug 01, 2002
NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR
K021342 · JEY
Osteomedics, Inc.
Dental · 94d
Cleared Aug 01, 2002
DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS
K021352 · FIP
Dayton Water Systems
Gastroenterology & Urology · 94d
Cleared Aug 01, 2002
CLINPRO PROPHY POWDER
K021450 · KOJ
3M Espe AG Dental Products
Dental · 87d
Cleared Aug 01, 2002
STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL...
K021452 · LZA
Maxxim Medical
General Hospital · 87d
Cleared Aug 01, 2002
ER150/M2
K021456 · GCJ
World of Medicine Lemke GmbH
General & Plastic Surgery · 87d
Cleared Aug 01, 2002
FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL
K021457 · EBG
Pentron Corp.
Dental · 87d
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