FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
80617–80640 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2000
PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING
K002942 · LLZ
Philips Medical Systems North...
Radiology · 89d
Cleared Dec 19, 2000
PRECISA BIOPSY NEEDLE
K002944 · FCG
H.S. Hospital Service S.R.L.
Gastroenterology & Urology · 89d
Cleared Dec 19, 2000
SILENT BIOPSY NEEDLE
K002946 · FCG
H.S. Hospital Service S.R.L.
Gastroenterology & Urology · 89d
Cleared Dec 19, 2000
BIOMOL ASPIRATION BIOPSY NEEDLE
K002947 · FCG
H.S. Hospital Service S.R.L.
Gastroenterology & Urology · 89d
Cleared Dec 19, 2000
NEURO II
K002964 · LNH
Innovative Magnetic Resonance Imaging...
Radiology · 88d
Cleared Dec 19, 2000
ACTIS ADJUSTABLE CONSTRICTION LOOP
K003115 · LKY
Vivus, Inc.
Gastroenterology & Urology · 78d
Cleared Dec 19, 2000
VARIANT II TOTAL GHB
K003280 · LCP
Bio-Rad
Hematology · 61d
Cleared Dec 19, 2000
PLASMAKINETIC ENDOUROLOGY SYSTEM
K003569 · KNS
Gyrus Medical , Ltd.
Gastroenterology & Urology · 29d
Cleared Dec 18, 2000
SATURN BLOOD GLUCOSE MONITORING TEST STRIP
K001441 · CGA
Lifescan, Inc.
Chemistry · 224d
Cleared Dec 18, 2000
VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM)...
K001927 · DSY
Thoratec Laboratories Corp.
Cardiovascular · 175d
Cleared Dec 18, 2000
MEGAVISION CPX, MEGAVISION FA, MODEL I AND II
K002920 · HKI
Escalon Medical Corp.
Ophthalmic · 90d
Cleared Dec 18, 2000
DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM
K002923 · LXT
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Dec 18, 2000
EHC400 DESKTOP PATIENT STATION
K002984 · DQD
Cybercare Technologies, Inc.
Cardiovascular · 84d
Cleared Dec 18, 2000
GRAMS POLYPROPYLENE NONABSORBABLE SUTURE
K002999 · GAW
Gramsmed, LLC
General & Plastic Surgery · 83d
Cleared Dec 18, 2000
GRAMS NYLON NONABSORBABLE SUTURE
K003000 · GAR
Gramsmed, LLC
General & Plastic Surgery · 83d
Cleared Dec 18, 2000
MODIFICATION TO VNUS CLOSURE SYSTEM
K003092 · GEI
Vnus Medical Technologies, Inc.
General & Plastic Surgery · 76d
Cleared Dec 18, 2000
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
K003120 · LCP
Roche Diagnostics Corp.
Hematology · 74d
Cleared Dec 18, 2000
ROCHE DIAGNOSTICS CK-MB
K003158 · JHW
Roche Diagnostics Corp.
Chemistry · 69d
Cleared Dec 18, 2000
M2376A DEVICELINK SYSTEM, MODEL M2376A
K003622 · MWI
Agilent Technologies, Inc.
Cardiovascular · 24d
Cleared Dec 18, 2000
MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
K003721 · JJE
Olympus America, Inc.
Chemistry · 14d
Cleared Dec 18, 2000
TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0
K993406 · ITI
Permobil AB
Physical Medicine · 437d
Cleared Dec 15, 2000
AIW WATER SYSTEM FOR HEMODIALYSIS
K001282 · FIP
American Industrial Water
Gastroenterology & Urology · 238d
Cleared Dec 15, 2000
QUICKIE 2 POWER ASSIST WHEELCHAIR
K001491 · ITI
Sunrise Medical, Inc.
Physical Medicine · 217d
Cleared Dec 15, 2000
M-XX OXYGEN SENSORS
K002384 · CCL
International Business Strategies
Anesthesiology · 133d