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
337–360 of 599
Search insights Median review: 81d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
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