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
70897–70920 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 17, 2003
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K032269 · HRS
Synthes (Usa)
Orthopedic · 56d
Cleared Sep 17, 2003
THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM
K032495 · DZE
Lifecore Biomedical, Inc.
Dental · 35d
Cleared Sep 17, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE
K032567 · LON
Becton, Dickinson & CO
Microbiology · 28d
Cleared Sep 17, 2003
TSRH SPINAL SYSTEM
K032578 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Sep 17, 2003
UNITY NETWORK PATIENT DATA SERVER
K032582 · MSX
Ge Medical Systems Information...
Cardiovascular · 27d
Cleared Sep 17, 2003
RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629
K032584 · GEI
Rubicor Medical, Inc.
General & Plastic Surgery · 27d
Cleared Sep 17, 2003
LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
K032611 · GGN
Bio-Rad
Hematology · 23d
Cleared Sep 17, 2003
APAX PACS SYSTEM
K032760 · LLZ
Tis, Inc.
Radiology · 12d
Cleared Sep 16, 2003
AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060
K030504 · MCW
Idev Technologies, Inc.
Cardiovascular · 209d
Cleared Sep 16, 2003
PENTACAM SCHEIMPFLUG CAMERA
K030719 · MXK
Oculus Optikgerate GmbH
Ophthalmic · 193d
Cleared Sep 16, 2003
CANDELA SMOOTHBEAM LASER SYSTEM
K030846 · GEX
Candela Corp.
General & Plastic Surgery · 183d
Cleared Sep 16, 2003
DIOBEAM 830
K031499 · NHN
Soft-Core Texas, Inc.
Physical Medicine · 126d
Cleared Sep 16, 2003
SOPRO 61D
K031593 · GCJ
Sopro
General & Plastic Surgery · 118d
Cleared Sep 16, 2003
OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS
K031632 · DZE
Implant Innovations, Inc.
Dental · 112d
Cleared Sep 16, 2003
MEDLINE REUSABLE SURGICAL GOWNS (100X)
K031933 · FYA
Medline Industries, Inc.
General Hospital · 85d