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
81217–81240 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2000
CHEMO-AIDE DISPENSING PIN
K003730 · LHI
Baxter Healthcare Corp
General Hospital · 16d
Cleared Dec 20, 2000
ELECSYS DHEA-S CALCHECK
K003772 · JJX
Roche Diagnostics Corp.
Chemistry · 14d
Cleared Dec 20, 2000
COOLTOUCH VARIA-II ND:YAG LASER SYSTEM
K003781 · GEX
Cooltouch Corp.
General & Plastic Surgery · 13d
Cleared Dec 19, 2000
MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM
K000081 · JAQ
Isotopes and Metals , Ltd.
Radiology · 343d
Cleared Dec 19, 2000
APPRAISE URINE MICROALBUMIN COLLECTION KIT
K002156 · CGX
Osborn Group, Inc.
Chemistry · 155d
Cleared Dec 19, 2000
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
K002393 · HIS
Innolatex Sdn. Bhd
Obstetrics & Gynecology · 134d
Cleared Dec 19, 2000
BAYER RAPIDPOINT 400 SYSTEM
K002738 · CHL
Bayer Corp.
Chemistry · 109d
Cleared Dec 19, 2000
GOLD CORE HF PRE SOLDER
K002815 · EJT
Jeneric/Pentron, Inc.
Dental · 99d
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