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
385–408 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jan 13, 2012
VARIOUS
K112417 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 143d
Cleared Jan 09, 2012
LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2)...
K112960 · MBI
Cayenne Medical, Inc.
Orthopedic · 96d
Cleared Dec 15, 2011
CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK...
K112876 · MBI
Cayenne Medical, Inc.
Orthopedic · 76d
Cleared Dec 15, 2011
ROG SUTURE ANCHOR
K113299 · MBI
Rog Sports Medicine, Inc.
Orthopedic · 37d
Cleared Dec 08, 2011
MODIFIED ROG SUTURE ANCHOR
K112991 · MBI
Rog Sports Medicine, Inc.
Orthopedic · 63d
Cleared Dec 01, 2011
LATERAL BUTTON
K112296 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 114d
Cleared Nov 10, 2011
KNOTLESS SUTURE FIXATION SYSTEM
K111716 · MBI
Core Essence Orthopaedics
Orthopedic · 143d
Cleared Nov 02, 2011
NANO SUTURE ANCHOR
K112965 · MBI
Linvatec Corporation D/B/A Conmed...
Orthopedic · 28d
Cleared Sep 27, 2011
META-LOCK SUTURE ANCHOR SYSTEM
K110800 · MBI
Tarsus Medical, Inc.
Orthopedic · 189d
Cleared Aug 19, 2011
BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR
K110879 · MBI
Biomet Sports Medicine
Orthopedic · 142d
Cleared Aug 19, 2011
ARTHREX SCAPHOLUNATE ANCHOR
K111661 · MBI
Arthrex, Inc.
Orthopedic · 66d
Cleared Aug 09, 2011
SPEEDLOCK KNOTLESS FIXATION DEVICE
K111044 · MBI
ArthroCare Corporation
Orthopedic · 116d
Cleared Aug 08, 2011
ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR
K111590 · MBI
Rog Sports Medicine, Inc.
Orthopedic · 62d
Cleared Aug 08, 2011
Y-KNOT ALL-SUTURE ANCHOR MODEL HF13
K111779 · MBI
Conmed Linvatec
Orthopedic · 45d
Cleared Jul 22, 2011
GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR,...
K111631 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 39d
Cleared Jul 20, 2011
SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED...
K111399 · MBI
Arthrocare Corp.
Orthopedic · 62d
Cleared Jul 12, 2011
TITAN TI SUTURE ANCHOR SYSTEM
K111397 · MBI
Arthrocare Corp.
Orthopedic · 54d
Cleared Jun 24, 2011
SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
K110545 · MBI
Smith & Nephew, Inc.
Orthopedic · 119d
Cleared Jun 16, 2011
MAXFIRE MARXMEN MENISCAL REPAIR DEVICE
K111564 · MBI
Biomet Sports Medicine
Orthopedic · 10d
Cleared Jun 10, 2011
EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)
K111471 · MBI
Medshape Solutions, Inc.
Orthopedic · 14d
Cleared Jun 02, 2011
TORNIER INSITE FT SUTURE ANCHOR
K110773 · MBI
Tornier, Inc.
Orthopedic · 73d
Cleared May 27, 2011
5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES,...
K110781 · MBI
Arthrocare Corp.
Orthopedic · 67d
Cleared May 25, 2011
NANOTACK SUTURE ANCHOR 1.4MM
K110473 · MBI
Pivot Medical
Orthopedic · 96d
Cleared May 19, 2011
ROG KNOTLESS SUTURE ANCHOR
K110230 · MBI
Rog Sports Medicine, Inc.
Orthopedic · 113d