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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: MBI ×
599 results
361–384 of 599
Search insights Median review: 81d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Oct 11, 2012
APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT...
K122463 · MBI
Cayenne Medical, Inc.
Orthopedic · 59d
Cleared Oct 02, 2012
6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED...
K122123 · MBI
Depuy Mitek, Inc., A Johnson and...
Orthopedic · 76d
Cleared Sep 21, 2012
SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP...
K120943 · MBI
ArthroCare Corporation
Orthopedic · 176d
Cleared Jul 26, 2012
STRYKER ALL SUTURE ANCHORS
K120509 · MBI
Stryker
Orthopedic · 156d
Cleared Jul 18, 2012
3.9MM REELX STT SUTURE ANCHOR SYSTEM
K120824 · MBI
Stryker Corp.
Orthopedic · 121d
Cleared Jun 22, 2012
BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN
K121018 · MBI
Smith & Nephew, Inc.
Orthopedic · 79d
Cleared Jun 07, 2012
APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR
K120841 · MBI
Kfx Medical
Orthopedic · 79d
Cleared Apr 20, 2012
PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR...
K120942 · MBI
Parcus Medical, LLC
Orthopedic · 22d
Cleared Mar 27, 2012
MULTIFIX P KNOTLESS FIXATION DEVICE
K120096 · MBI
ArthroCare Corporation
Orthopedic · 75d
Cleared Mar 06, 2012
FOOTPRINT ULTRA PK SUTURE ANCHOR
K113274 · MBI
Smith & Nephew, Inc.
Orthopedic · 120d
Cleared Mar 02, 2012
KNOTILUS ANCHOR SYSTEM
K113297 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 115d
Cleared Feb 17, 2012
ARTHREX KNOTLESS SUTURETAK ANCHOR
K120155 · MBI
Arthrex, Inc.
Orthopedic · 30d
Cleared Jan 31, 2012
TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS
K112526 · MBI
Smith & Nephew, Inc.
Orthopedic · 153d
Cleared Jan 20, 2012
SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR
K113294 · MBI
Smith & Nephew, Inc.
Orthopedic · 73d
Cleared Jan 17, 2012
CUFFINK
K112814 · MBI
Cayenne Medical, Inc.
Orthopedic · 112d
Cleared Jan 17, 2012
PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF...
K113730 · MBI
Parcus Medical, LLC
Orthopedic · 29d
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