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
44545–44568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 2012
SOLITAIRE-C CERVICAL SPACER SYSTEM
K113796 · OVE
Ebi, LLC
Orthopedic · 125d
Cleared Apr 26, 2012
TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM
K120437 · GEX
Biolitec Sia (Latvia)
General & Plastic Surgery · 73d
Cleared Apr 26, 2012
DEPUY PULSE CERVICAL CAGE SYSTEM
K120517 · ODP
Medos International SARL
Orthopedic · 65d
Cleared Apr 26, 2012
AERONEB PRO
K120939 · CAF
Aerogen, Ltd.
Anesthesiology · 28d
Cleared Apr 26, 2012
C-QUR RPM MESH
K121070 · FTL
Atrium Medical Corp.
General & Plastic Surgery · 17d
Cleared Apr 25, 2012
SHARPS TANK REUSABLE SHARPS CONTAINER
K111085 · MMK
Rehrig Pacific Company
General Hospital · 372d
Cleared Apr 25, 2012
SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS
K112611 · MNI
Sintea Plastek, LLC
Orthopedic · 231d
Cleared Apr 25, 2012
ZOLL PROPAQ MD
K112761 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 216d
Cleared Apr 25, 2012
ELECTROCARDIOGRAPH
K113485 · DPS
Shenzhen Carewell Electronics Co., Ltd.
Cardiovascular · 154d
Cleared Apr 25, 2012
NASAL/EPISTAXIS PACK
K113585 · LYA
Cogent Therapeutics, LLC
Ear, Nose, Throat · 142d
Cleared Apr 25, 2012
VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX...
K113760 · HRS
Howmedica Osteonics Corp., Dba...
Orthopedic · 126d
Cleared Apr 25, 2012
HYDROCOIL EMBOLIC SYSTEM (HES)
K120908 · HCG
MicroVention, Inc.
Neurology · 30d
Cleared Apr 25, 2012
CAREFUSION NICOLET EDX
K120979 · GWF
Carefusion 209, Inc.
Neurology · 23d
Cleared Apr 24, 2012
AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
K103230 · CGA
Bestgen Biotech Corp.
Chemistry · 540d
Cleared Apr 24, 2012
BRAIN BIOPSY NEEDLE
K112094 · HAW
Ad-Tech Medical Instrument Corp
Neurology · 277d
Cleared Apr 24, 2012
APLAN A.V. FISTULA NEEDLE SET
K112734 · FIE
Aplan Well Enterprise Co., Ltd.
Gastroenterology & Urology · 217d
Cleared Apr 24, 2012
OSTEOMED WRIST PLATING SYSTEM
K120015 · HRS
Osteomed LP
Orthopedic · 112d
Cleared Apr 24, 2012
HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE...
K120055 · MRX
Hamilton Thorne, Inc.
Obstetrics & Gynecology · 106d
Cleared Apr 24, 2012
CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO...
K120086 · DRA
Cardiosolutions
Cardiovascular · 104d
Cleared Apr 24, 2012
EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)
K120231 · GEX
Biolitec Medical Devices, Inc.
General & Plastic Surgery · 90d
Cleared Apr 24, 2012
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
K120452 · FGE
Flexible Stenting Solutions, Inc.
Gastroenterology & Urology · 70d
Cleared Apr 24, 2012
MILAGRO INTERFERENCE SCREWS
K120589 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 56d
Cleared Apr 24, 2012
PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION
K120645 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 53d
Cleared Apr 24, 2012
PICCOLO HDL-CAPILLARY TEST SYSTEM
K120662 · JHM
Abaxis, Inc.
Chemistry · 50d