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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
145705–145728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1986
MEDILAS 2
K853580 · LKW
Endo Lase, Inc.
Neurology · 171d
Cleared Feb 13, 1986
ULTRASOUND COUPLANT SHEET/SOLID ULTRASOUND COUPLAN
K853702 · IYO
Johnson & Johnson Professionals, Inc.
Radiology · 162d
Cleared Feb 13, 1986
VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)
K853737 · IYY
Capintec, Inc.
Radiology · 160d
Cleared Feb 13, 1986
PMT ACCUPRESSURE INFUSION SYSTEM 3601
K854157 · FRN
Progress Mankind Technology
General Hospital · 125d
Cleared Feb 13, 1986
VASC-EZ
K854428 · DWL
Barton-Carey Medical Products Co.
General Hospital · 100d
Cleared Feb 13, 1986
PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T
K854471 · EWG
Minnesota Laser Corp.
Ear, Nose, Throat · 99d
Cleared Feb 13, 1986
DIGITAL SCREENING AUDIOMETER DSA6214
K854534 · EWO
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 92d
Cleared Feb 13, 1986
SURGICAL DRAPES, OPHTHALMIN
K854613 · HMT
Charles Atkins & Co.
General Hospital · 87d
Cleared Feb 13, 1986
TERUMO SENSIBEAD EIG HCG KIT
K854670 · JHJ
Terumo Medical Corp.
Chemistry · 84d
Cleared Feb 13, 1986
CBC-CAL/MULTIPLE
K854823 · KSA
R&D Systems, Inc.
Hematology · 72d
Cleared Feb 13, 1986
VFI/VFE SYSTEM II
K854872
Mira, Inc.
Ophthalmic · 71d
Cleared Feb 13, 1986
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
K854939 · DHB
Pharmacia, Inc.
Immunology · 65d
Cleared Feb 13, 1986
JMS INFUSION SET
K860242 · FPA
Sturbridge Medical
General Hospital · 20d
Cleared Feb 13, 1986
DIAMOND BLADE MICROMETER KNIFE
K860332 · HNN
Med-Tech Develoment Corp.
Ophthalmic · 15d
Cleared Feb 12, 1986
FENLIN TOTAL SHOULDER
K852137
Zimmer, Inc.
Orthopedic · 272d
Cleared Feb 12, 1986
FEMOROTIBIAL MEDULLARY NAIL
K853250 · HSB
Zimmer, Inc.
Orthopedic · 195d
Cleared Feb 12, 1986
VERIFLEX
K854410 · KPZ
Old Delft Corp. of America
Radiology · 103d
Cleared Feb 12, 1986
TBX MEDICAL X-RAY TABLE
K854459 · IXJ
Gendex Corp.
Radiology · 98d
Cleared Feb 12, 1986
EMPI MODEL 720 NMS
K854774 · IPF
Empi
Physical Medicine · 75d
Cleared Feb 12, 1986
EMPI MODEL 730 NMS
K854775 · IPF
Empi
Physical Medicine · 75d
Cleared Feb 12, 1986
MULTIPLE I.V. SETS
K854804 · FPA
C. B. Dumont Company, Inc.
General Hospital · 72d
Cleared Feb 12, 1986
LS1000 SURGICAL ASPIRATOR II
K854844 · BTA
Engineering, Inc.
General & Plastic Surgery · 70d
Cleared Feb 12, 1986
FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER
K854863 · LDR
Travenol Laboratories, S.A.
General Hospital · 69d
Cleared Feb 12, 1986
SANDHILL ELECTRONIC CALIPER
K854933 · IXC
Sandhill
Radiology · 64d