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
139081–139104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 1987
CORONARY ARTERY BYPASS GRAFT (CABG) MARKER
K871110 · DSY
Edward Weck, Inc.
Cardiovascular · 161d
Cleared Aug 27, 1987
MODEL 1858 CAVRO/PRESSURE MODULE
K872077 · EXY
Life-Tech Intl., Inc.
Gastroenterology & Urology · 90d
Cleared Aug 27, 1987
BACTIGEN GROUP B STREPTOCOCCUS-CS TEST
K872114 · GTZ
Armkel, LLC
Microbiology · 87d
Cleared Aug 27, 1987
BIOMET MODULAR SHOULDER PROSTHESIS
K872454 · KWT
Biomet, Inc.
Orthopedic · 65d
Cleared Aug 27, 1987
PROTHROMBIN TIME TEST
K872537 · GJS
Sclavo, Inc.
Hematology · 63d
Cleared Aug 27, 1987
MAM-CP X-RAY APPARATUS
K872980 · IZH
Transworld X-Ray Corp.
Radiology · 28d
Cleared Aug 27, 1987
KODAK MIN-R MEDIUM SCREEN
K873167 · EAM
Eastman Kodak Company
Radiology · 16d
Cleared Aug 26, 1987
OPHTHASONIC A-SCAN/ B-SCAN
K871536 · IYO
Teknar, Inc.
Radiology · 128d
Cleared Aug 26, 1987
DISCIPLINE II RTD
K871557 · IKK
Physio Systems, Inc.
Physical Medicine · 126d
Cleared Aug 26, 1987
ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST
K871601 · LCX
Advanced Care Products
Chemistry · 124d
Cleared Aug 26, 1987
FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM
K871846 · KNT
Abbott Laboratories
Gastroenterology & Urology · 106d
Cleared Aug 26, 1987
CENTURION SPECIMEN TRAP W/CATHETER
K872141 · BSY
Tri-State Hospital Supply Corp.
Anesthesiology · 85d
Cleared Aug 26, 1987
KERR CAVALITE
K872147 · EJK
Kerr Corporation (Danbury)
Dental · 83d
Cleared Aug 26, 1987
BILE ACIDS REAGENT
K872296 · KWW
Sigma Diagnostics, Inc.
Chemistry · 71d
Cleared Aug 26, 1987
BIOPRO FEMORAL HIP COMPONENT
K872535 · KWL
Biopro, Inc.
Orthopedic · 61d
Cleared Aug 26, 1987
INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR
K872647 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 50d
Cleared Aug 26, 1987
BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL
K872777 · JJY
Biotrol, USA, Inc.
Chemistry · 43d
Cleared Aug 26, 1987
BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM
K872785 · JJY
Biotrol, USA, Inc.
Chemistry · 43d
Cleared Aug 26, 1987
OVONIC COATED SURGICAL SCISSORS
K873046 · LRW
Micrins, Ltd.
General & Plastic Surgery · 22d
Cleared Aug 25, 1987
ROTA-STAT
K864811 · LIQ
Intl. Diagnostic Laboratories, Ltd.
Microbiology · 259d
Cleared Aug 25, 1987
IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI
K871246 · LSR
Zeus Scientific, Inc.
Microbiology · 151d
Cleared Aug 25, 1987
PROTOFLUOR Z
K871499 · JKJ
Helena Laboratories
Toxicology · 131d
Cleared Aug 25, 1987
CODMAN FLEXIBLE ENDOSCOPE
K871978 · GCQ
Codman & Shurtleff, Inc.
Gastroenterology & Urology · 95d
Cleared Aug 25, 1987
MMG URO-SELF CATHETER
K871999 · GBM
Medical Marketing Group
Gastroenterology & Urology · 91d