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
409–432 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared May 18, 2011
ROG SUTURE ANCHOR 5.5MM, 2.9MM
K110229 · MBI
Rog Sports Medicine, Inc.
Orthopedic · 112d
Cleared Apr 05, 2011
QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM
K103262 · MBI
Tornier, Inc.
Orthopedic · 152d
Cleared Mar 04, 2011
BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR
K110145 · MBI
Biomet, Inc.
Orthopedic · 45d
Cleared Feb 24, 2011
ICUFF REPAIR PLATE, RIGHT
K102539 · MBI
Shoulder Options, Inc.
Orthopedic · 174d
Cleared Feb 09, 2011
HAMMERLOC TM TIBIAL FIXATION DEVICE
K103145 · MBI
Biomet Sports Medicine
Orthopedic · 107d
Cleared Feb 07, 2011
5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL
K110164 · MBI
Arthrocare Corp.
Orthopedic · 19d
Cleared Jan 06, 2011
THE GRAPPLR AND GRAPPLR EXTENDER
K101616 · MBI
Tag Medical Corp.
Orthopedic · 211d
Cleared Jan 05, 2011
ARTHREX TIBIAL GRAFTBOLT
K103060 · MBI
Arthrex, Inc.
Orthopedic · 79d
Cleared Dec 13, 2010
BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS
K102660 · MBI
Smith & Nephew Endoscopy, Inc.
Orthopedic · 89d
Cleared Dec 02, 2010
PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS
K101126 · MBI
Core Essence Orthopaedics, Inc.
Orthopedic · 224d
Cleared Oct 29, 2010
SPEEDFIX SUTURE SYSTEM
K101437 · MBI
Arthrocare Corp.
Orthopedic · 158d
Cleared Oct 21, 2010
ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM
K102262 · MBI
Arthrocare Corp.
Orthopedic · 72d
Cleared Oct 20, 2010
INTRAFIX TIBIAL SHEATH
K102443 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 55d
Cleared Jun 23, 2010
SLEEVE WITH ZIPLOOP FIXATION DEVICES
K101063 · MBI
Biomet Sports Medicine
Orthopedic · 68d
Cleared Jun 21, 2010
OPUS SPEEDSCREW SYSTEM
K101448 · MBI
Arthrocare Corp.
Orthopedic · 28d
Cleared Jun 11, 2010
G-FORCE PEEK SUTURE ANCHOR SYSTEM
K100630 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 98d
Cleared May 20, 2010
KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTER
K101175 · MBI
Kfx Medical
Orthopedic · 23d
Cleared May 18, 2010
TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N,...
K101184 · MBI
Arthrocare Corp.
Orthopedic · 20d
Cleared Apr 19, 2010
SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR
K100159 · MBI
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 89d
Cleared Apr 05, 2010
SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR
K093935 · MBI
Smith & Nephew, Inc.
Orthopedic · 104d
Cleared Mar 26, 2010
G-FORCE TI SUTURE ANCHOR SYSTEM
K100579 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 24d
Cleared Mar 18, 2010
ARTHREX TIBIAL GRAFTBOLT
K093912 · MBI
Arthrex, Inc.
Orthopedic · 86d
Cleared Mar 05, 2010
BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM
K093943 · MBI
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 73d
Cleared Mar 04, 2010
SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR
K093897 · MBI
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 76d