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: MBI ×
601 results
457–480 of 601
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Jul 14, 2006
OPUS LABRALOCK P KNOTLESS FIXATION DEVICE
K061349 · MBI
Arthrocare Corp.
Orthopedic · 60d
Cleared Jun 08, 2006
KINSA SUTURE ANCHOR
K061154 · MBI
Smith & Nephew, Inc.
Orthopedic · 43d
Cleared Feb 03, 2006
EZLOC FEMORAL FIXATION DEVICE
K053461 · MBI
Arthrotek, Inc.
Orthopedic · 52d
Cleared Dec 20, 2005
SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
K052810 · MBI
Scandius Biomedical, Inc.
Orthopedic · 77d
Cleared Dec 05, 2005
ANSPACH KNOTLESS ANCHOR
K052572 · MBI
The Anspach Effort, Inc.
Orthopedic · 77d
Cleared Oct 07, 2005
AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR
K052491 · MBI
Axya Medical, Inc.
Orthopedic · 25d