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

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176,076 results
55921–55944 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 2008
FDTX GLUCOSE CONTROL SOLUTION
K081915 · JJX
Fujirebio Diagnostics Texas, Inc.
Chemistry · 36d
Cleared Aug 08, 2008
LASERPEEL SOFT-MET MODIFIED ERBIUM LASER
K082028 · GEX
Global USA Distribution, LLC
General & Plastic Surgery · 22d
Cleared Aug 07, 2008
NEONATAL TOTAL GALACTOSE KIT
K071649 · JIA
Wallac OY
Chemistry · 416d
Cleared Aug 07, 2008
FAMILI OF IRIDEX IQ LASER SYSTEMS
K071687 · GEX
Iridex Corp
General & Plastic Surgery · 416d
Cleared Aug 07, 2008
APROXI 1100 AND 4000 SERIES DENTAL INLAYS
K073047 · EBF
Aproxi Aps
Dental · 283d
Cleared Aug 07, 2008
ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG
K073396 · FPA
B.Braun Medical, Inc.
General Hospital · 248d
Cleared Aug 07, 2008
VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES
K073499 · JDL
Zimmer, Inc.
Orthopedic · 238d
Cleared Aug 07, 2008
ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE
K080606 · LYY
Alatech Healthcare, LLC
General Hospital · 156d
Cleared Aug 07, 2008
ATLAS-BASED AUTOSEGMENTATION
K080799 · LHN
Computerized Medical Systems, Inc.
Radiology · 139d
Cleared Aug 07, 2008
LOVE GUARD MALE LATEX CONDOM
K080833 · HIS
Tianjin Human-Care Latex Corporation
Obstetrics & Gynecology · 135d
Cleared Aug 07, 2008
ARCTIC BLAST INTRAVENOUS FLUID CHILLER
K080899 · NCX
Medivance, Inc.
Neurology · 129d
Cleared Aug 07, 2008
MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
K080930 · IYO
U-System, Inc.
Radiology · 127d
Cleared Aug 07, 2008
PROVENT NASAL CANNULA
K080983 · MNR
Ventus Medical, Inc.
Anesthesiology · 122d
Cleared Aug 07, 2008
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE
K081051 · HRX
Spine View, Inc.
Orthopedic · 115d
Cleared Aug 07, 2008
TCM ENDO 20
K081191 · EKX
NOUVAG AG
Dental · 101d
Cleared Aug 07, 2008
PEEK-OPTIMA ALIF SPACER
K081636 · MAX
Biomet Spine
Orthopedic · 57d
Cleared Aug 07, 2008
MODIFICATION TO GFX NERVE ABLATION SYSTEM
K081729 · GXD
Bioform Medical, Inc.
Neurology · 50d
Cleared Aug 07, 2008
OCULAR RESPONSE ANALYZER
K081756 · HKX
Reichert, Inc.
Ophthalmic · 48d
Cleared Aug 07, 2008
NAVIGATOR APPLICATIONS SUITE
K081941 · BSZ
GE Healthcare Finland Oy
Anesthesiology · 30d
Cleared Aug 07, 2008
METHA SHORT STEM HIP SYSTEM
K081973 · LZO
Aesculap Implant Systems, Inc.
Orthopedic · 28d
Cleared Aug 06, 2008
FOSSA URETERAL OPEN STENTS
K072293 · FAD
Fossa Medical, Inc.
Gastroenterology & Urology · 356d
Cleared Aug 06, 2008
MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC
K072486 · QSY
Hem Con Medical Technologies, Inc.
General & Plastic Surgery · 337d
Cleared Aug 06, 2008
DIGIMATCH ROBODOC SURGICAL SYSTEM
K072629 · OJP
Integrated Surgical Systems, Inc.
Orthopedic · 324d
Cleared Aug 06, 2008
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K080484 · MRN
Ino Therapeutics
Anesthesiology · 166d