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
457–480 of 591
Search insights Median review: 81d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared May 16, 2007
STRYKER PEEK ZIP SUTURE ANCHOR
K070758 · MBI
Stryker Endoscopy
Orthopedic · 57d
Cleared May 16, 2007
SMITH & NEPHEW KINSA RC SUTURE ANCHOR
K070908 · MBI
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 44d
Cleared Apr 16, 2007
OPUS MAGNUM PI KNOTLESS FIXATION DEVICE
K070227 · MBI
Arthrocare Corp.
Orthopedic · 82d
Cleared Apr 12, 2007
ENDOBUTTON DIRECT
K070167 · MBI
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 84d
Cleared Feb 13, 2007
CINCH BONE ANCHOR SYSTEM
K062739 · MBI
Sapphire Medical, Inc.
Orthopedic · 153d
Cleared Jan 25, 2007
FEMORAL INTRAFIX SCREW AND SHEATH
K063577 · MBI
Johnson & Johnson Company
Orthopedic · 56d
Cleared Dec 19, 2006
MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
K063499 · MBI
Scandius Biomedical, Inc.
Orthopedic · 29d
Cleared Jul 19, 2006
KFX KNOTLESS FIXATION SYSTEM
K061294 · MBI
Kfx Medical
Orthopedic · 71d
Cleared Jul 14, 2006
OPUS LABRALOCK P KNOTLESS FIXATION DEVICE
K061349 · MBI
Arthrocare Corp.
Orthopedic · 60d
Cleared Jun 08, 2006
KINSA SUTURE ANCHOR
K061154 · MBI
Smith & Nephew, Inc.
Orthopedic · 43d
Cleared Feb 03, 2006
EZLOC FEMORAL FIXATION DEVICE
K053461 · MBI
Arthrotek, Inc.
Orthopedic · 52d
Cleared Dec 20, 2005
SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
K052810 · MBI
Scandius Biomedical, Inc.
Orthopedic · 77d
Cleared Dec 05, 2005
ANSPACH KNOTLESS ANCHOR
K052572 · MBI
The Anspach Effort, Inc.
Orthopedic · 77d
Cleared Oct 07, 2005
AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR
K052491 · MBI
Axya Medical, Inc.
Orthopedic · 25d
Cleared Jun 29, 2005
NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER
K051069 · MBI
Arthrotek, Inc.
Orthopedic · 64d
Cleared Mar 02, 2005
THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER
K050227 · MBI
Linvatec Corp.
Orthopedic · 29d
Cleared Nov 12, 2004
OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE
K042914 · MBI
Opus Medical, Inc.
Orthopedic · 22d
Cleared Oct 29, 2004
TI - SCREW ANCHOR SP
K042460 · MBI
Arthrotek, Inc.
Orthopedic · 49d
Cleared Jul 22, 2004
SUPER REVO HERCULINE SUTURE ANCHOR
K041713 · MBI
Linvatec Corp.
Orthopedic · 29d
Cleared Jun 25, 2004
OPUS MAGNUM ANCHOR WITH INSERTER
K041440 · MBI
Opus Medical, Inc.
Orthopedic · 24d
Cleared Jun 14, 2004
STRYKER WEDGE SUTURE ANCHOR SYSTEM
K041310 · MBI
Stryker Endoscopy
Orthopedic · 28d
Cleared Jun 07, 2004
FEMORAL HOOK
K041261 · MBI
Arthrotek, Inc.
Orthopedic · 27d
Cleared Feb 13, 2004
TITANIUM TOGGLE BUTTON(S)
K033838 · MBI
Biomet Manufacturing, Inc.
Orthopedic · 65d
Cleared May 05, 2003
ADHOC CLAW
K023963 · MBI
Future Medical Systems, Inc.
Orthopedic · 157d