FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
70369–70392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 17, 2003
SORB+HISORB+CARTRIDGE
K031099 · FKT
Renal Solutions, Inc.
Gastroenterology & Urology · 163d
Cleared Sep 17, 2003
FLEX-NECK PD CATHETER, INFANT
K031351 · FJS
Medigroup, Inc.
Gastroenterology & Urology · 141d
Cleared Sep 17, 2003
SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM
K031855 · KWQ
Spinal Concepts, Inc.
Orthopedic · 93d
Cleared Sep 17, 2003
ONLINE TDM CARBAMAZEPINE
K031902 · KLT
Roche Diagnostics Corp.
Toxicology · 89d
Cleared Sep 17, 2003
PROCEED TRILAMINATE SURGICAL MESH
K031925 · FTL
Ethicon, Inc.
General & Plastic Surgery · 86d
Cleared Sep 17, 2003
TSRH SPINAL SYSTEM
K031967 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 83d
Cleared Sep 17, 2003
CONDUCTIVITY STANDARD SOLUTION-METERCARE
K032075 · FKH
Ibp Instruments GmbH
Gastroenterology & Urology · 72d
Cleared Sep 17, 2003
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K032137 · FGE
Cordis Corp.
Gastroenterology & Urology · 68d
Cleared Sep 17, 2003
R&D DESIGNATION AP-052-5
K032267 · EJT
Jensen Industries, Inc.
Dental · 56d