FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
70873–70896 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 2003
HALM ZIELKE INSTRUMENTATION SYSTEM
K024125 · KWQ
Micomed Ortho GmbH
Orthopedic · 280d
Cleared Sep 22, 2003
ESKA MODULAR HIP SYSTEM CEMENTED
K030867 · JDI
Eska Implants GmbH
Orthopedic · 187d
Cleared Sep 22, 2003
ULTRA-DRIVE 3
K031280 · JDX
Biomet, Inc.
Neurology · 153d
Cleared Sep 22, 2003
GLYCOMARK
K031604 · NOZ
Tomen America, Inc.
Chemistry · 123d
Cleared Sep 22, 2003
ALEXIS WOUND RETRACTOR
K031889 · KKX
Applied Medical Resources Corp.
General Hospital · 96d
Cleared Sep 22, 2003
ARTHREX TRIMIT SCREW, MODEL AR-4161B
K031945 · HWC
Arthrex, Inc.
Orthopedic · 90d
Cleared Sep 22, 2003
MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET
K031955 · FTL
Macropore Biosurgery, Inc.
General & Plastic Surgery · 89d
Cleared Sep 22, 2003
MEDLINE BAND BAGS AND EQUIPMENT COVERS
K032065 · MMP
Medline Industries, Inc.
General Hospital · 81d
Cleared Sep 22, 2003
PROCLASS PRESS FIT HIP STEM
K032110 · LWJ
Stelkast Company
Orthopedic · 75d
Cleared Sep 22, 2003
CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)
K032169 · LXT
Cyberorthology, Inc.
Orthopedic · 68d
Cleared Sep 22, 2003
ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM
K032187 · HRS
Arthrex, Inc.
Orthopedic · 67d
Cleared Sep 22, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML
K032299 · LON
Becton, Dickinson & CO
Microbiology · 59d
Cleared Sep 22, 2003
WAGNER CONE PROSTHESIS
K032380 · LZO
Centerpulse Orthopedics, Inc.
Orthopedic · 52d
Cleared Sep 22, 2003
ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST
K032510 · LCX
ACON Laboratories, Inc.
Chemistry · 39d
Cleared Sep 22, 2003
LARGE VOLUME FLUID RESERVOIR
K032778 · LGZ
Belmont Instrument Corp.
General Hospital · 14d
Cleared Sep 17, 2003
BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)
K023758 · OKS
Fci Ophthalmics, Inc.
Ophthalmic · 313d
Cleared Sep 17, 2003
GALIX WINTER
K030145 · DQK
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 245d
Cleared Sep 17, 2003
CRESCENT TINNITUS RETAINING SOUND GENERATOR
K030180 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 243d
Cleared Sep 17, 2003
BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
K030570 · BTO
Portex , Ltd.
Anesthesiology · 205d
Cleared Sep 17, 2003
FETAL SPIRAL ELECTRODE, MODEL FSE07000
K030691 · HGP
Clinical Innovations, Inc.
Obstetrics & Gynecology · 196d
Cleared Sep 17, 2003
AKERS LABORATORIES INC. BLOOD CELL SEPARATOR
K030815 · JKA
Akers Laboratories, Inc.
Chemistry · 187d
Cleared Sep 17, 2003
SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5
K030821 · MUJ
Simuplan S.L.
Radiology · 187d
Cleared Sep 17, 2003
PRIMOSPLINT SYSTEM
K030832 · MQC
Cosmedent, Inc.
Dental · 184d
Cleared Sep 17, 2003
D-STAT-DRY HEMOSTATIC BANDAGE
K030836 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 184d