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
156721–156744 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 16, 1983
TOTAL PROTEIN PROCEDURE
K832169 · CEK
Sandare Chemical Co., Inc.
Chemistry · 41d
Cleared Aug 16, 1983
DIGILAB 350 THE KRAKAU PERIMETER
K832175 · HPT
Bio-Rad
Ophthalmic · 41d
Cleared Aug 16, 1983
HC40/HC75 CATION EXCHANGE RESIN
K832199 · DNH
Hamilton Co.
Toxicology · 40d
Cleared Aug 16, 1983
PRP-1 REVERSED PHASE COLUMNS FOR HPLC
K832200 · DPM
Hamilton Co.
Toxicology · 40d
Cleared Aug 16, 1983
CHROM-PREP
K832201 · KZR
Hamilton Co.
Toxicology · 40d
Cleared Aug 16, 1983
ORTHOPEDIC CASTING TAPE MAXCAST
K832237 · ITG
Cutter Laboratories, Inc.
Physical Medicine · 36d
Cleared Aug 16, 1983
ACUFLEX LEVY ACL DRILL GUIDE SYS
K832277 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 35d
Cleared Aug 16, 1983
MARK I TOTAL KNEE SYS. ARTHROPLASTY
K832302 · MBV
Advanced Biosearch Assn.
Orthopedic · 33d
Cleared Aug 16, 1983
US-1000 ULTRASONIC IMAGING SYSTEM
K832331 · IYO
Nidek, Inc.
Radiology · 29d
Cleared Aug 16, 1983
MEDIC LUX DIAGNOSTIC SETS
K832437 · HLJ
Keeler Instruments, Inc.
Ophthalmic · 22d
Cleared Aug 16, 1983
POLYCORE
K832461
Polycore Optical Pte , Ltd.
Ophthalmic · 21d
Cleared Aug 16, 1983
MASSAGE TABLE AAT-100
K832464 · JFB
R&D Systems, Inc.
Physical Medicine · 21d
Cleared Aug 16, 1983
GAMMA SLIDE TEST FOR PREGNANCY
K832473 · JHJ
Gamma Biologicals, Inc.
Chemistry · 21d
Cleared Aug 16, 1983
OCULOPRESSOR
K832477
Hans Gevder
Ophthalmic · 21d
Cleared Aug 16, 1983
SCOLIOMETER
K832494
Orthopedic Systems, Inc.
Physical Medicine · 20d
Cleared Aug 13, 1983
VASCULAR GRAFT/BIFURCATED/FEP-RINGED
K830806 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 152d
Cleared Aug 12, 1983
GELIPERM TRANSPARENT GEL-FILM DRESSING
K822058 · FRO
Hamel, Park, Mccabe & Saunders
General & Plastic Surgery · 395d
Cleared Aug 12, 1983
GELIPERM DRY
K822073 · FRO
Hamel, Park, Mccabe & Saunders
General & Plastic Surgery · 393d
Cleared Aug 12, 1983
GELIPERM GRANULES
K823225 · FRO
Geistlich-Pharma
General & Plastic Surgery · 287d
Cleared Aug 12, 1983
BIOELECTRICAL IMPEDANCE ANALYZER #101
K830292 · DSB
Rjl Systems, Inc.
Cardiovascular · 197d
Cleared Aug 12, 1983
CARDIO-ESOPHASCOPE
K830716 · BZT
Portex, Inc.
Anesthesiology · 157d
Cleared Aug 12, 1983
BLOOD PRESSURE MONITORING KITS,WALRUS
K830754 · DXT
Medical Parameters, Inc.
Cardiovascular · 155d
Cleared Aug 12, 1983
GONOCHEK PANEL
K830756 · JTO
E-Y Laboratories, Inc.
Microbiology · 155d
Cleared Aug 12, 1983
POLYCHACO INDIRECT HEMAGGLUTINATION
K830870 · GMM
Parasitic Disease Consultants
Microbiology · 147d