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
75241–75264 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 2002
S2 TIBIAL NAIL
K022481 · HSB
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Aug 26, 2002
AART CALF IMPLANT
K022511 · MIB
Aesthetic and Reconstructive...
General & Plastic Surgery · 27d
Cleared Aug 26, 2002
POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LESS)
K022530 · LYY
Hycare Intl. Co., Ltd.
General Hospital · 26d
Cleared Aug 26, 2002
2MM PEDIATRIC FLEX NAIL
K022531 · HTY
Biomet, Inc.
Orthopedic · 26d
Cleared Aug 26, 2002
ACCOLADE C FEMORAL STEMS
K022555 · LZO
Howmedica Osteonics Corp.
Orthopedic · 24d
Cleared Aug 26, 2002
POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL)
K022601 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 21d
Cleared Aug 26, 2002
MODIFICATION TO AVALON CUP SYSTEM
K022711 · LPH
Orthopedic Source, Inc.
Orthopedic · 12d
Cleared Aug 23, 2002
ENOXAPARIN TEST CARD
K013305 · KFF
Cardiovascular Diagnostics, Inc.
Hematology · 323d
Cleared Aug 23, 2002
ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE
K020220 · LFL
Synergetics, Inc.
General & Plastic Surgery · 213d
Cleared Aug 23, 2002
DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR
K020400 · GWF
Meps, LLC
Neurology · 198d
Cleared Aug 23, 2002
3T VESSEL CANNULAS
K020768 · DWF
3t Medical Systems, LLC
Cardiovascular · 169d
Cleared Aug 23, 2002
CHITO-SEAL
K021062 · QSY
Abbott Vascular, Inc.
General & Plastic Surgery · 143d
Cleared Aug 23, 2002
BCLEAR
K021762 · FTC
Lumenis, Inc.
General & Plastic Surgery · 86d
Cleared Aug 23, 2002
ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
K021819 · NBW
Lifescan, Inc.
Chemistry · 80d
Cleared Aug 23, 2002
BRAINET
K021986 · GXY
Nicolet Biomedical, Inc.
Neurology · 66d
Cleared Aug 23, 2002
BOLTON PTA CATHETER
K021996 · LIT
Bolton Medical, Inc.
Cardiovascular · 66d
Cleared Aug 23, 2002
SURGISIS STAPLE LINE REINFORCEMENT
K022044 · OXE
Cook Biotech, Inc.
General & Plastic Surgery · 60d
Cleared Aug 23, 2002
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS...
K022072 · CIX
Precision Systems, Inc.
Chemistry · 58d
Cleared Aug 23, 2002
SURGETICS ENTACT ENDONASAL NAVIGATION SYSTEM
K022239 · JAK
Praxim
Radiology · 43d
Cleared Aug 23, 2002
LITE MINERAL OIL
K022332 · MQL
Intl., Inc.
Obstetrics & Gynecology · 36d
Cleared Aug 23, 2002
ALLGRAD AND ALLGRAD100
K022335 · MQL
Intl., Inc.
Obstetrics & Gynecology · 36d
Cleared Aug 23, 2002
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
K022350 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 35d
Cleared Aug 23, 2002
UNI KNEE
K022437 · HRY
Encore Medical, L.P.
Orthopedic · 29d
Cleared Aug 23, 2002
MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL
K022487 · MOS
Mri Devices Corp.
Radiology · 25d