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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
48817–48840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 2010
HIP SEXTANT INSTRUMENT SYSTEM
K093491 · OSF
Surgical Planning Associates
Orthopedic · 394d
Cleared Dec 09, 2010
PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399
K100854 · EGS
Premium Plus International Limited
Dental · 258d
Cleared Dec 09, 2010
STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM
K101046 · DTX
Sorin Group Deutschland GmbH
Cardiovascular · 239d
Cleared Dec 09, 2010
IMMULISA DSDNA ANTIBODY ELISA
K101319 · LRM
Immco Diagnostics, Inc.
Immunology · 212d
Cleared Dec 09, 2010
SELF RETAINING SOFT TISSUE RETRACTOR
K101609 · LXH
Koros USA, Inc.
Orthopedic · 184d
Cleared Dec 09, 2010
PREVISION HIP SYSTEM WITH RECON RING
K102424 · MEH
Aesculap Implant Systems, LLC
Orthopedic · 106d
Cleared Dec 09, 2010
NOBEL ACTIVE 3.0
K102436 · DZE
Nobel Biocare AB
Dental · 105d
Cleared Dec 09, 2010
MULLINS-X PTV CATHETER
K102473 · OMZ
NuMED, Inc.
Cardiovascular · 101d
Cleared Dec 09, 2010
KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K102609 · DXN
Andon Medical Co., Ltd.
Cardiovascular · 90d
Cleared Dec 09, 2010
2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
K102694 · HRS
Synthes (Usa)
Orthopedic · 80d
Cleared Dec 09, 2010
MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS
K102723 · MWJ
Memtec Corp.
Cardiovascular · 79d
Cleared Dec 09, 2010
OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS
K102989 · IYN
Chang Gung Medical Technology Co.,...
Radiology · 64d
Cleared Dec 08, 2010
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
K093641 · FIN
Tango3, LLC
Gastroenterology & Urology · 379d
Cleared Dec 08, 2010
NEMA-ST, MODEL V1.0.2
K100668 · GZJ
Nervomatrix, Ltd.
Neurology · 274d
Cleared Dec 08, 2010
QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL:...
K101153 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 229d
Cleared Dec 08, 2010
3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M...
K101910 · FRC
3M Company
General Hospital · 152d
Cleared Dec 08, 2010
SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM
K102143 · JDR
Suspension Orthopaedic Solutions, LLC
Orthopedic · 131d
Cleared Dec 08, 2010
OPTIGEN TOTAL KNEE SYSTEM
K102367 · JWH
U&I Corp.
Orthopedic · 110d
Cleared Dec 08, 2010
MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER
K102659 · FRO
Manuka Medical Limited
General & Plastic Surgery · 84d
Cleared Dec 08, 2010
HYDROCOLOR 5
K102739 · ELW
Cascades Device Consulting Associates
Dental · 77d
Cleared Dec 08, 2010
CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT...
K102965 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 64d
Cleared Dec 08, 2010
AURA
K102984 · EBF
Sdi Limited
Dental · 62d
Cleared Dec 08, 2010
PRUITT CAROTID KIT
K103356 · MJN
LeMaitre Vascular, Inc.
General & Plastic Surgery · 22d
Cleared Dec 08, 2010
SEEKER CROSSING SUPPORT CATHETER
K103367 · DQY
Bard Peripheral Vascular, Inc.
Cardiovascular · 22d