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
361–384 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jan 23, 2013
FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL
K123579 · MBI
Smith & Nephew, Inc.
Orthopedic · 65d
Cleared Jan 09, 2013
Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL...
K122336 · MBI
Eleven Blade Solutions, Inc.
Orthopedic · 160d
Cleared Dec 21, 2012
ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON,...
K123341 · MBI
Arthrex, Inc.
Orthopedic · 51d
Cleared Dec 19, 2012
CINCHER-2.6 SUTURE ANCHOR MODEL FG-001
K122954 · MBI
Foundry Newcoxi, Inc.
Orthopedic · 85d
Cleared Dec 11, 2012
NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD
K120356 · MBI
Ncs Lab Srl
Orthopedic · 309d
Cleared Nov 09, 2012
MICRO/MINI N-PK(F) BONE ANCHOR
K121354 · MBI
Anulex Technologies, Inc.
Orthopedic · 189d
Cleared Nov 09, 2012
MICRO/MINI N-PK(H) BONE ANCHOR
K121356 · MBI
Anulex Technologies, Inc.
Orthopedic · 189d
Cleared Oct 31, 2012
QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY
K122314 · MBI
Cayenne Medical, Inc.
Orthopedic · 91d
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