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
337–360 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Oct 07, 2013
CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM
K131769 · MBI
Pivot Medical, Inc.
Orthopedic · 112d
Cleared Sep 19, 2013
Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM...
K132513 · MBI
ArthroCare Corporation
Orthopedic · 38d
Cleared Sep 19, 2013
TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES
K132632 · MBI
Tornier, Inc.
Orthopedic · 28d
Cleared Sep 17, 2013
5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION...
K132590 · MBI
ArthroCare Corporation
Orthopedic · 29d
Cleared Aug 29, 2013
ROTATION MEDICAL BONE STAPLE (RMB STAPLE)
K131635 · MBI
Rotation Medical, Inc.
Orthopedic · 86d
Cleared Aug 16, 2013
QUATTRO GL SUTURE ANCHOR
K131325 · MBI
Cayenne Medical, Inc.
Orthopedic · 100d
Cleared Aug 01, 2013
TOGGLELOC XTENDER
K130033 · MBI
Biomet Manufacturing Corp
Orthopedic · 209d
Cleared Aug 01, 2013
RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM,...
K130814 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 129d
Cleared Jul 29, 2013
MULTIFIX S KNOTLESS FIXATION DEVICE
K131182 · MBI
Arthocare Corporation
Orthopedic · 94d
Cleared Jul 02, 2013
Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM
K131035 · MBI
Linvatec Corporation D/B/A Conmed...
Orthopedic · 81d
Cleared Jun 27, 2013
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)
K131683 · MBI
Depuy Mitek, Inc., A Johnson and...
Orthopedic · 17d
Cleared Jun 20, 2013
ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
K130217 · MBI
OrthoPediatrics Corp.
Orthopedic · 142d
Cleared May 21, 2013
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM)
K130539 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 81d
Cleared May 03, 2013
KNOTLESS FIBERTAK SUTURE ANCHOR
K130458 · MBI
Arthrex, Inc.
Orthopedic · 70d
Cleared Mar 18, 2013
ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR...
K122059 · MBI
Smith & Nephew, Inc.
Orthopedic · 248d
Cleared Mar 18, 2013
JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS...
K123485 · MBI
Biomet Sports Medicine
Orthopedic · 125d
Cleared Mar 14, 2013
NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER
K130351 · MBI
Pivot Medical, Inc.
Orthopedic · 30d
Cleared Mar 07, 2013
ECLIPSE SOFT TISSUE FASTENER
K123350 · MBI
MedShape, Inc.
Orthopedic · 127d
Cleared Mar 05, 2013
COLS® FIXATION SYSTEM
K120740 · MBI
Fournitures Hospitalieres Industrie
Orthopedic · 358d
Cleared Feb 27, 2013
SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER...
K130196 · MBI
Arthrocare Corp.
Orthopedic · 30d
Cleared Feb 21, 2013
CINCHLOCK KNOTLESS SUTURE ANCHOR
K123651 · MBI
Pivot Medical
Orthopedic · 86d
Cleared Feb 20, 2013
TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
K123425 · MBI
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Feb 14, 2013
SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT
K123240 · MBI
ArthroCare Corporation
Orthopedic · 121d
Cleared Feb 05, 2013
PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR
K122805 · MBI
Parcus Medical, LLC
Orthopedic · 145d