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
74353–74376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 2002
MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR
K022101 · LZA
Latexx Manufacturing Sdn.Bhd.
General Hospital · 35d
Cleared Aug 02, 2002
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K022246 · FMF
Depuyacromed
General Hospital · 21d
Cleared Aug 02, 2002
DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, &...
K022317 · LZG
Sooil Development Co., Ltd.
General Hospital · 16d
Cleared Aug 02, 2002
RELYX RMGIP
K022476 · EMA
3M Company
Dental · 4d
Cleared Aug 01, 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K012687 · NLH
Vanguard Medical Concepts, Inc.
Cardiovascular · 352d
Cleared Aug 01, 2002
MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES
K012693 · CBK
Acutronic Medical Systems AG
Anesthesiology · 352d
Cleared Aug 01, 2002
PALL ULTIPOR ANESTHESIA BREATHING SYSTEM
K013093 · CAH
Pall Medical
General Hospital · 318d
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