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
46369–46392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 2011
PALINDROME H, SI, HSI CHRONIC CATHETER
K112477 · NYU
Covidien
Gastroenterology & Urology · 30d
Cleared Sep 28, 2011
PIONEER CROSSFUSE II IBF/VBR SYSTEM
K112496 · MAX
Pioneer Surgical Technology, Inc.
Orthopedic · 30d
Cleared Sep 28, 2011
ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
K112556 · MEH
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared Sep 27, 2011
COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION
K103396 · NBW
I-Sens, Inc.
Chemistry · 312d
Cleared Sep 27, 2011
EXETER HIP STEM
K110290 · JDI
Howmedica Osteonics Corp.
Orthopedic · 238d
Cleared Sep 27, 2011
HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER
K110673 · IYN
Hitachi Medical Systems America, Inc.
Radiology · 202d
Cleared Sep 27, 2011
META-LOCK SUTURE ANCHOR SYSTEM
K110800 · MBI
Tarsus Medical, Inc.
Orthopedic · 189d
Cleared Sep 27, 2011
NMR LIPOPROFILE (R) TEST AND NMR PROFILER
K111516 · LBS
Liposcience, Inc.
Chemistry · 118d
Cleared Sep 27, 2011
AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM
K111697 · HQC
Abbott Medical Optics, Inc.
Ophthalmic · 102d
Cleared Sep 27, 2011
RADIAL ARTERY COMPRESSION TOURNIQUET
K111837 · DXC
Lepu Medical Technology (Beijing)...
Cardiovascular · 90d
Cleared Sep 27, 2011
ISOAMP HSV ASSAY
K111951 · OQO
Biohelix Corporation
Microbiology · 81d
Cleared Sep 27, 2011
VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN
K112129 · LON
bioMerieux, Inc.
Microbiology · 63d
Cleared Sep 27, 2011
LOGIQ P3
K112371 · IYN
Ge Healthcare
Radiology · 41d
Cleared Sep 27, 2011
CD HORIZON(R) SPINAL SYSTEM
K112555 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 25d
Cleared Sep 27, 2011
SONIX ULTRASOUND SCANNER
K112726 · IYN
Ultrasonix Medical Corporation
Radiology · 7d
Cleared Sep 26, 2011
KEPLER MEDTEC DISPOSABLE BIPOLAR CABLE
K110462 · GEI
Kepler Medtec
General & Plastic Surgery · 221d
Cleared Sep 26, 2011
PASS LP SPINAL SYSTEM
K110497 · MNH
Medicrea International
Orthopedic · 216d
Cleared Sep 26, 2011
ASTRA TECH IMPLANT SYSTEM
K111287 · DZE
Astra Tech AB
Dental · 143d
Cleared Sep 26, 2011
21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR
K111496 · LLZ
Totoku Electric Co., Ltd.
Radiology · 118d
Cleared Sep 26, 2011
CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE
K111614 · HGM
Ge Healthcare Integrated IT Solutions
Obstetrics & Gynecology · 110d
Cleared Sep 26, 2011
SURGICASE ORTHOGNATHIC SOFTWARE WIZARD
K111641 · LLZ
Materialise NV
Radiology · 105d
Cleared Sep 26, 2011
SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS
K111809 · OAT
Biomaterials Korea, Inc.
Dental · 91d
Cleared Sep 26, 2011
INQU PASTE MIX
K111838 · MQV
Isto Technologies, Inc.
Orthopedic · 89d
Cleared Sep 26, 2011
SELECTRA ACCESSORY KIT
K111839 · DQY
Biotronik, Inc.
Cardiovascular · 89d