FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: MBI ×
591 results
385–408 of 591
Search insights Median review: 81d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jul 12, 2011
TITAN TI SUTURE ANCHOR SYSTEM
K111397 · MBI
Arthrocare Corp.
Orthopedic · 54d
Cleared Jun 24, 2011
SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
K110545 · MBI
Smith & Nephew, Inc.
Orthopedic · 119d
Cleared Jun 16, 2011
MAXFIRE MARXMEN MENISCAL REPAIR DEVICE
K111564 · MBI
Biomet Sports Medicine
Orthopedic · 10d
Cleared Jun 10, 2011
EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)
K111471 · MBI
Medshape Solutions, Inc.
Orthopedic · 14d
Cleared Jun 02, 2011
TORNIER INSITE FT SUTURE ANCHOR
K110773 · MBI
Tornier, Inc.
Orthopedic · 73d
Cleared May 27, 2011
5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES,...
K110781 · MBI
Arthrocare Corp.
Orthopedic · 67d
Cleared May 25, 2011
NANOTACK SUTURE ANCHOR 1.4MM
K110473 · MBI
Pivot Medical
Orthopedic · 96d
Cleared May 19, 2011
ROG KNOTLESS SUTURE ANCHOR
K110230 · MBI
Rog Sports Medicine, Inc.
Orthopedic · 113d
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