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
75265–75288 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 2002
MODEL OBC-63 BREAST ARRAY COIL
K022488 · MOS
Mri Devices Corp.
Radiology · 25d
Cleared Aug 23, 2002
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02
K022507 · MSX
Datex-Ohmeda
Cardiovascular · 24d
Cleared Aug 23, 2002
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
K022538 · JIR
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 22d
Cleared Aug 23, 2002
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K022554 · JXG
Integra Neurosciences
Neurology · 21d
Cleared Aug 23, 2002
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K022561 · NFK
C.R. Bard, Inc.
Gastroenterology & Urology · 21d
Cleared Aug 23, 2002
ENDIUS FLEXTIP BLADE
K022578 · HRX
Endius, Inc.
Orthopedic · 18d
Cleared Aug 23, 2002
MODIFICATION TO MEDAMICUS AXIA RSN
K022689 · DYB
Medamicus, Inc.
Cardiovascular · 10d
Cleared Aug 22, 2002
NANMA ADJUSTABLE CONSTRICTION RING
K013051 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 345d
Cleared Aug 22, 2002
ULTRASTIM KIT
K013532 · GZJ
Axelgaard Mfg. Co., Ltd.
Neurology · 309d
Cleared Aug 22, 2002
XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT
K020226 · JWZ
Hellen Professional Services
Microbiology · 212d
Cleared Aug 22, 2002
ARTERIA BLOOD FILTER
K021293 · FPB
Arteria Medical Science, Inc.
General Hospital · 121d
Cleared Aug 22, 2002
CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION...
K022102 · LZA
Latexx Manufacturing Sdn.Bhd.
General Hospital · 55d
Cleared Aug 22, 2002
BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K022128 · HQD
Bausch & Lomb, Incorporated
Ophthalmic · 52d
Cleared Aug 22, 2002
SIGNA 3.0T MAGNETIC RESONANCE SYSTEM
K022397 · LNH
GE Medical Systems
Radiology · 30d
Cleared Aug 22, 2002
DISPOSABLE PRESSURE MANOMETER
K022402 · CAP
Vital Signs, Inc.
Anesthesiology · 30d
Cleared Aug 22, 2002
CONTOUR SE MICROSPHERES
K022427 · HCG
Boston Scientific Corp
Neurology · 28d
Cleared Aug 22, 2002
S2 FEMORAL NAIL
K022461 · HSB
Howmedica Osteonics
Orthopedic · 27d
Cleared Aug 22, 2002
ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC
K022480 · HIH
Acmi Corporation
Obstetrics & Gynecology · 27d
Cleared Aug 22, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438
K022707 · DIF
Bio-Rad
Chemistry · 8d
Cleared Aug 21, 2002
COSMOS SYSTEM
K013046 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 345d
Cleared Aug 21, 2002
SURE-LOK
K021315 · FMI
Vital Signs, Inc.
General Hospital · 118d
Cleared Aug 21, 2002
REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP
K021528 · JOW
Adven Medical
Cardiovascular · 103d
Cleared Aug 21, 2002
FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY
K021972 · CDZ
Qualigen, Inc.
Chemistry · 65d
Cleared Aug 21, 2002
TRIONOMER
K022150 · EMA
Pentron Clinical Technologies
Dental · 50d