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
83257–83280 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 20, 2000
ACON ONE STEP HOME PREGNANCY TEST STRIP
K993483 · LCX
ACON Laboratories, Inc.
Chemistry · 98d
Cleared Jan 20, 2000
MODIFICATION TO LASER-SHIELD II
K993582 · BTR
Xomed, Inc.
Anesthesiology · 90d
Cleared Jan 20, 2000
HP M2376A DEVICE LINK SYSTEM
K993587 · MQS
Hewlett-Packard Co.
Gastroenterology & Urology · 90d
Cleared Jan 20, 2000
MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205
K993598 · LMA
Vidar Systems Corp.
Radiology · 87d
Cleared Jan 20, 2000
MRI EQUIPMENT COVER
K993682 · LNH
Image-Guided Neurologics, Inc.
Radiology · 80d
Cleared Jan 20, 2000
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT
K993736 · LPH
Exactech, Inc.
Orthopedic · 77d
Cleared Jan 20, 2000
EC-7701 FLUID WARMING CABINET
K993797 · LDQ
Enthermics Medical Systems, Inc.
General & Plastic Surgery · 72d
Cleared Jan 20, 2000
MSAS PROFESSIONAL
K993824 · GZO
Biomeridian, Int.
Neurology · 69d
Cleared Jan 20, 2000
UFI GEL HARD
K993827 · EBI
Voco GmbH
Dental · 69d
Cleared Jan 20, 2000
COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES
K993864 · LYY
Supermax Sdn Bhd
General Hospital · 66d
Cleared Jan 20, 2000
GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
K993865 · LYY
Supermax Sdn Bhd
General Hospital · 66d
Cleared Jan 20, 2000
SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL
K994005 · DJR
Syva Co.
Chemistry · 57d
Cleared Jan 20, 2000
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100...
K994013 · LYY
Glovco (M) Sdn. Bhd.
General Hospital · 55d
Cleared Jan 20, 2000
CAUTERY GRASPER/DISSECTOR
K994019 · HQP
Starion Instruments
Ophthalmic · 55d
Cleared Jan 20, 2000
MTP DISPOSABLE TROCARS
K994066 · GCJ
Mtp Medical Technical Promotion GmbH
General & Plastic Surgery · 50d
Cleared Jan 20, 2000
REVELATION POROUS HIP STEM
K994070 · LPH
Encore Orthopedics, Inc.
Orthopedic · 49d
Cleared Jan 20, 2000
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
K994084 · FFS
Smith & Nephew, Inc.
Gastroenterology & Urology · 48d
Cleared Jan 20, 2000
DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR
K994114 · JIS
Dade Behring, Inc.
Chemistry · 45d
Cleared Jan 20, 2000
STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTECH...
K994173 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 41d
Cleared Jan 20, 2000
OLYMPUS CREATINE KINASE REAGENT OSR6179/6279
K994189 · CGS
Olympus Diagnostica GmbH
Chemistry · 38d
Cleared Jan 20, 2000
SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES...
K994258 · LYZ
Shinemound Enterprise, Inc.
General Hospital · 34d
Cleared Jan 20, 2000
MODEL 1000 HOLMIUM LASER SYSTEM
K994273 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 31d
Cleared Jan 19, 2000
SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM
K000030 · IYO
Medison America, Inc.
Radiology · 14d
Cleared Jan 19, 2000
WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK
K991545 · DXQ
Industrielle Entwicklung...
Cardiovascular · 261d