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: MBI ×
607 results
457–480 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jul 28, 2008
OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS...
K081497 · MBI
Arthrocare Corp.
Orthopedic · 60d
Cleared Jul 03, 2008
SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200)...
K081598 · MBI
Kfx Medical
Orthopedic · 27d
Cleared Jun 13, 2008
SURGICRAFT SCREW FIXATION SYSTEM
K080447 · MBI
Surgicraft , Ltd.
Orthopedic · 115d
Cleared Apr 23, 2008
TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM
K080335 · MBI
Tornier, Inc.
Orthopedic · 76d
Cleared Feb 29, 2008
5.5 MM SUTURE LOCK BONE SCREW ANCHOR
K080229 · MBI
Kfx Medical
Orthopedic · 30d
Cleared Jan 07, 2008
THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES
K073481 · MBI
Conmed Linvatec
Orthopedic · 27d
Cleared Dec 07, 2007
CINCH KNOTLESS FIXATION IMPLANT SYSTEM
K073226 · MBI
C2m Medical, Inc.
Orthopedic · 22d
Cleared Oct 26, 2007
KFX TISSUE FIXATION SYSTEM AND ACCESSORIES
K072063 · MBI
Kfx Medical
Orthopedic · 91d
Cleared Oct 11, 2007
AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR
K070773 · MBI
Axya Medical, Inc.
Orthopedic · 204d
Cleared Sep 17, 2007
SLEEVE AND BUTTON SOFT TISSUE DEVICES
K071704 · MBI
Biomet Sports Medicine, Inc.
Orthopedic · 88d
Cleared Aug 21, 2007
CONMED LINVATEC XO BUTTON
K070780 · MBI
Conmed Linvatec
Orthopedic · 153d
Cleared Aug 17, 2007
BIORAPTOR 2.3 PK SUTURE ANCHOR
K071586 · MBI
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 67d
Cleared Aug 10, 2007
RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X
K071520 · MBI
Core Essence Orthopaedics, LLC
Orthopedic · 67d
Cleared Aug 02, 2007
OPUS TWINLOCK KNOTLESS FIXATION DEVICE
K071374 · MBI
Arthrocare Corp.
Orthopedic · 78d
Cleared Jul 20, 2007
STRYKER PEEK TWINLOOP TAC
K070882 · MBI
Stryker Endoscopy
Orthopedic · 112d
Cleared Jul 02, 2007
ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER
K071569 · MBI
Biomet, Inc.
Orthopedic · 24d
Cleared May 16, 2007
STRYKER PEEK ZIP SUTURE ANCHOR
K070758 · MBI
Stryker Endoscopy
Orthopedic · 57d
Cleared May 16, 2007
SMITH & NEPHEW KINSA RC SUTURE ANCHOR
K070908 · MBI
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 44d
Cleared Apr 16, 2007
OPUS MAGNUM PI KNOTLESS FIXATION DEVICE
K070227 · MBI
Arthrocare Corp.
Orthopedic · 82d
Cleared Apr 12, 2007
ENDOBUTTON DIRECT
K070167 · MBI
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 84d
Cleared Feb 13, 2007
CINCH BONE ANCHOR SYSTEM
K062739 · MBI
Sapphire Medical, Inc.
Orthopedic · 153d
Cleared Jan 25, 2007
FEMORAL INTRAFIX SCREW AND SHEATH
K063577 · MBI
Johnson & Johnson Company
Orthopedic · 56d
Cleared Dec 19, 2006
MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
K063499 · MBI
Scandius Biomedical, Inc.
Orthopedic · 29d
Cleared Jul 19, 2006
KFX KNOTLESS FIXATION SYSTEM
K061294 · MBI
Kfx Medical
Orthopedic · 71d