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
70489–70512 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 2003
TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG...
K033383 · NBC
Biosite Incorporated
Chemistry · 61d
Cleared Dec 23, 2003
LONG LOVE CONDOM
K033541 · HIS
Unidus Corp.
Obstetrics & Gynecology · 43d
Cleared Dec 23, 2003
IRRIGATION CHANNEL TUBING, MODEL 100135
K033695 · OCX
Byrne Medical, Inc.
Gastroenterology & Urology · 28d
Cleared Dec 23, 2003
MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1
K033712 · LLZ
Sectra-Imtec AB
Radiology · 27d
Cleared Dec 23, 2003
SYNGO PERFUSION-CT
K033832 · JAK
Siemens AG Medical Solutions
Radiology · 13d
Cleared Dec 23, 2003
A1CNOW FOR HOME AND PROFESSIONAL USE
K033847 · LCP
Metrika, Inc.
Chemistry · 12d
Cleared Dec 22, 2003
FIDJI SMALL CEMENT RESTRICTOR
K030767 · JDK
Spine Next SA
Orthopedic · 286d
Cleared Dec 22, 2003
FIDJI LARGE CEMENT RESTRICTOR
K030871 · JDK
Spine Next SA
Orthopedic · 278d
Cleared Dec 22, 2003
CERABIEN ZR
K031968 · EIH
Noritake Co., Inc.
Dental · 179d
Cleared Dec 22, 2003
B&R DEVICE
K032925 · EGS
Ronvig A/S
Dental · 91d
Cleared Dec 22, 2003
RH-950
K033192 · KTB
Iomed, Inc.
Physical Medicine · 81d
Cleared Dec 22, 2003
EPRICORD
K033267 · EBF
Kuraray Medical, Inc.
Dental · 74d
Cleared Dec 22, 2003
VINYL EXAMINATION GLOVES, POWDERED
K033308 · LYZ
Tangshan Transocean Plastic Products...
General Hospital · 69d
Cleared Dec 22, 2003
CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY...
K033394 · FGE
Cordis Corp.
Gastroenterology & Urology · 60d
Cleared Dec 22, 2003
MESACUP-2 TEST JO-1, MODEL 10756
K033528 · LLL
Rhigene, Inc.
Immunology · 45d
Cleared Dec 22, 2003
VERSYO.BOND
K033629 · EBI
Heraeus Kulzer, Inc.
Dental · 33d
Cleared Dec 22, 2003
CLINICAL LASETTE P-200
K033799 · GEX
Cell Robotics, Inc.
General & Plastic Surgery · 17d
Cleared Dec 19, 2003
BAY AREA HYPERSCIENCES
K030713 · CBF
Bay Area Hypersciences, LLC
Anesthesiology · 288d
Cleared Dec 19, 2003
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES...
K031260 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 242d
Cleared Dec 19, 2003
IXL DIABETES MANAGEMENT SYSTEM
K031373 · LZG
Insulet Corp.
General Hospital · 233d
Cleared Dec 19, 2003
MEDISCOPE
K031436 · HEX
Sometech Corporation
Obstetrics & Gynecology · 227d
Cleared Dec 19, 2003
INSTAREAD LITHIUM SYSTEM
K031579 · JIH
Akers Laboratories, Inc.
Toxicology · 213d
Cleared Dec 19, 2003
TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
K031831 · HKO
Topcon Medical Systems, Inc.
Ophthalmic · 189d
Cleared Dec 19, 2003
BAYER CLINITEK STATUS ANALYZER
K031947 · KQO
Bayer Healthcare, LLC
Chemistry · 178d