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

Filters: Cleared only ×
175,820 results
44209–44232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 2012
ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC...
K120033 · OMP
Kci USA, Inc.
General & Plastic Surgery · 148d
Cleared May 31, 2012
GETINGE 700HC-E SERIES STEAM STERILIZER
K120441 · FLE
Getinge Sourcing, LLC
General Hospital · 108d
Cleared May 31, 2012
CLEAN AND BOOST
K120620 · KLE
Apex Dental Materials, Inc.
Dental · 91d
Cleared May 31, 2012
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
K120944 · JOW
Covidien
Cardiovascular · 63d
Cleared May 31, 2012
SPECTRUM V.0
K121023 · LLZ
Intrinsic Medical Imaging
Radiology · 57d
Cleared May 31, 2012
OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE...
K121307 · JWH
Exactech, Inc.
Orthopedic · 30d
Cleared May 31, 2012
CLOSER TO NATURE
K121322 · HGX
Mayborn Group Limited
Obstetrics & Gynecology · 29d
Cleared May 31, 2012
GUIDEMIA
K121466 · LLZ
Guidemia Technologies, LLC
Radiology · 14d
Cleared May 30, 2012
KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
K111956 · PAF
Kronus Market Development Associates,...
Immunology · 324d
Cleared May 30, 2012
WIS1000
K112621 · GCJ
Foreseeson Custom Displays, Inc.
General & Plastic Surgery · 265d
Cleared May 30, 2012
ERAPID NEBULIZER SYSTEM
K112859 · CAF
Pari Respiratory Equipment, Inc.
Anesthesiology · 243d
Cleared May 30, 2012
SOLOHEALTH STATION
K113402 · DXN
Solohealth, Inc.
Cardiovascular · 195d
Cleared May 30, 2012
SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM
K113739 · LLZ
Materialise Dental NV
Radiology · 162d
Cleared May 30, 2012
ENDOSCOPIC RETRIEVAL DEVICE
K120084 · OCZ
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 140d
Cleared May 30, 2012
PROCARE PLUS VITRECTOMY SYSTEM
K120170 · HQE
Visioncare Devices, Inc.
Ophthalmic · 132d
Cleared May 30, 2012
ARTISAN SPACE MAINTENANCE SYSTEM
K120271 · JEY
Medtronic Sofamor Danek USA, Inc.
Dental · 121d
Cleared May 30, 2012
NERIA MULTI SUBCUTANEOUS INFUSION SET
K120395 · FPA
Unomedical Devices S.A DE C.V.
General Hospital · 112d
Cleared May 30, 2012
3M SPOTON TEMPERATURE MONITORING SYSTEM
K120412 · FLL
Arizant Healthcare, Inc.
General Hospital · 110d
Cleared May 30, 2012
TANDEMHEART FEMORAL ARTERIAL CANNULA SET
K120543 · DWF
Cardiacassist, Inc.
Cardiovascular · 97d
Cleared May 30, 2012
HAMILTON-C1
K120574 · CBK
Hamilton Medical AG
Anesthesiology · 93d
Cleared May 30, 2012
STAINLESS STEEL SPINAL SYSTEM
K120829 · NKB
Theken Spine, LLC
Orthopedic · 72d
Cleared May 30, 2012
SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE
K120882 · IYO
Bard Access Systems, Inc.
Radiology · 68d
Cleared May 30, 2012
BD EMERALD SAF-T SINGLE USE, HYPODERMIC
K121283 · FMF
Becton, Dickinson and Company
General Hospital · 30d
Cleared May 30, 2012
SOMNODENT G2
K121340 · LRK
Somnomed, Inc.
Dental · 27d