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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
55945–55968 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 2008
RFVISION, MODEL 9.9D
K080847 · OWB
Almana Medical Imaging
Radiology · 133d
Cleared Aug 06, 2008
SONIX MDP ULTRASOUND SCANNER
K080935 · IYN
Ultrasonix Medical Corporation
Radiology · 126d
Cleared Aug 06, 2008
HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM
K080966 · KPJ
Aoti , Ltd.
General & Plastic Surgery · 124d
Cleared Aug 06, 2008
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES
K081232 · HAW
Praxim
Neurology · 97d
Cleared Aug 06, 2008
TRICOS A RESORBABLE SUBSTITUTE
K081721 · LYC
Baxter Healthcare Corp
Dental · 49d
Cleared Aug 06, 2008
EDGE PACS
K081752 · LLZ
Ashva Technologies, Pvt., Ltd.
Radiology · 47d
Cleared Aug 06, 2008
GE VIVID E9 ULTRASOUND
K081921 · IYN
General Electric Co.
Radiology · 30d
Cleared Aug 06, 2008
GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL...
K082054 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 16d
Cleared Aug 06, 2008
ALLTECH ECHOSTAR 1.5 T MR SYSTEM
K082100 · LNH
Alltech Medical Systems America, Inc.
Radiology · 12d
Cleared Aug 06, 2008
KETTOSIL AND SILGINAT
K082157 · ELW
Kettenbach GmbH & Co. KG
Dental · 6d
Cleared Aug 05, 2008
DERMABIOSAFE
K080298 · GXY
Complete Product Resources
Neurology · 182d
Cleared Aug 05, 2008
EZ REGULAR
K080303 · FPA
Meinntech Co., Ltd.
General Hospital · 182d
Cleared Aug 05, 2008
HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED
K080603 · BSP
Te ME NA Sas
Anesthesiology · 155d
Cleared Aug 05, 2008
BIOPRO GO-EZ SCREW
K081149 · HWC
Biopro, Inc.
Orthopedic · 105d
Cleared Aug 05, 2008
PIONEER PLUS CATHETER
K081804 · PDU
Medtronic, Inc.
Cardiovascular · 40d
Cleared Aug 05, 2008
U-RIGHT TD-4247 BLOOD GLUCOSE MONITORING SYSTEM
K081957 · NBW
Taidoc Technology Corporation
Chemistry · 27d
Cleared Aug 05, 2008
MODIFICATION TO LUCENT
K081968 · MAX
Spinal Elements, Inc.
Orthopedic · 26d
Cleared Aug 05, 2008
DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
K081992 · MKW
Siemens Healthcare Diagnostics, Inc.
Toxicology · 22d
Cleared Aug 04, 2008
PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
K073381 · LJN
Focus Diagnostics, Inc.
Microbiology · 245d
Cleared Aug 04, 2008
SELF-ADHESIVE ELECTRODES
K080276 · GXY
Cathay Health Care Equipment...
Neurology · 182d
Cleared Aug 04, 2008
RADIANCE
K080749 · NJM
American Orthodontics
Dental · 140d
Cleared Aug 04, 2008
TEMPLATE AND COUNTER-FIT
K081017 · ELW
Clinician'S Choice Dental Products, Inc.
Dental · 117d
Cleared Aug 04, 2008
V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK...
K081289 · FPA
Baxter Healthcare Corp
General Hospital · 89d
Cleared Aug 04, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
K081319 · JIT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 84d