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

Filters: Cleared only ×
176,076 results
57097–57120 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2008
SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
K080109 · KTW
Synthes (Usa)
Orthopedic · 65d
Cleared Mar 20, 2008
ACUITY UNIVERSAL CUTTER
K080154 · DQY
Cardiac Pacemakers, Inc.
Cardiovascular · 57d
Cleared Mar 20, 2008
VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS
K080204 · JWH
Biomet, Inc.
Orthopedic · 52d
Cleared Mar 20, 2008
COLOR LCD MONITOR, MODEL RADIFORCE RX211
K080457 · LLZ
Eizo Nanao Corporation
Radiology · 29d
Cleared Mar 20, 2008
ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01
K080482 · GEI
Arthrocare Corp.
General & Plastic Surgery · 27d
Cleared Mar 20, 2008
PIONEER LOWTOP SPINAL ROD SYSTEM
K080504 · NKB
Pioneer Surgical Technology
Orthopedic · 24d
Cleared Mar 20, 2008
PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
K080518 · NKB
Pioneer Surgical Technology
Orthopedic · 24d
Cleared Mar 20, 2008
RUNTHROUGH NS EXTENSION WIRE
K080563 · DQX
Terumo Medical Corp.
Cardiovascular · 21d
Cleared Mar 19, 2008
ACTIVATED ASPARTATE AMINOTRANSFERASE
K071525 · CIT
Abbott Laboratories
Chemistry · 289d
Cleared Mar 19, 2008
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS:...
K072036 · LEH
Biokit, S.A.
Toxicology · 238d
Cleared Mar 19, 2008
AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
K072527 · DRM
Zoll Circulation
Cardiovascular · 194d
Cleared Mar 19, 2008
STRYKER ANTIMIC CATHETER
K072702 · BSO
Stryker Instruments, Instruments Div.
Anesthesiology · 177d
Cleared Mar 19, 2008
SINUS SPACER
K072891 · KAM
Acclarent, Inc.
General & Plastic Surgery · 161d
Cleared Mar 19, 2008
TUMARK PROFESSIONAL, MODEL 271560
K073095 · NEU
Somatex Medical Technologies GmbH
General & Plastic Surgery · 139d
Cleared Mar 19, 2008
KANTERON DICOM STATION (KDS), MODEL 3.0
K073176 · LLZ
Monica Veytia
Radiology · 127d
Cleared Mar 19, 2008
DURETTE IMPLANT
K073293 · HPZ
Oculo Plastik, Inc.
Ophthalmic · 117d
Cleared Mar 19, 2008
SBI SR MTP TOE IMPLANT
K073635 · KWD
Small Bone Innovations, Inc.
Orthopedic · 84d
Cleared Mar 19, 2008
SECURE
K073698 · EMA
Parkell, Inc.
Dental · 79d
Cleared Mar 19, 2008
TRAUMACAD VERSION 2.0
K073714 · LLZ
Orthocrat, Ltd.
Radiology · 79d
Cleared Mar 19, 2008
MEDLINE GASTROSTOMY TUBE
K073718 · KGC
Medline Industries, Inc.
Gastroenterology & Urology · 79d
Cleared Mar 19, 2008
LED.L, LED.M, LED.G, LED.B
K080025 · EBZ
Guilin Woodpecker Medical Instrument...
Dental · 75d
Cleared Mar 19, 2008
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
K080166 · JIT
Beckman Coulter, Inc.
Chemistry · 56d
Cleared Mar 19, 2008
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND...
K080291 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 44d
Cleared Mar 19, 2008
VARIAX DISTAL RADIUS TORX SCREWS
K080667 · HRS
Howmedica Osteonics Corp.
Orthopedic · 9d