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
409–432 of 591
Search insights Median review: 81d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Feb 04, 2010
OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL...
K092836 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 142d
Cleared Dec 23, 2009
CONMED LINVATEC INTERCEPT IMPLANT
K092998 · MBI
Linvatec Corp.
Orthopedic · 86d
Cleared Dec 17, 2009
SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR
K093428 · MBI
Smith & Nephew Endoscopy, Inc.
Orthopedic · 44d
Cleared Dec 15, 2009
SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR
K093228 · MBI
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Dec 09, 2009
WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES
K092914 · MBI
Medshape Solutions
Orthopedic · 78d
Cleared Sep 30, 2009
PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264
K091094 · MBI
Parcus Medical, LLC
Orthopedic · 167d
Cleared Sep 21, 2009
TORNIER, PITON FIXATION IMPLANT SYSTEM
K091870 · MBI
Tornier
Orthopedic · 90d
Cleared Jun 30, 2009
PARCUS GRAFT FIXATION SYSTEM
K090923 · MBI
Parcus Medical, LLC
Orthopedic · 90d
Cleared Jun 23, 2009
CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM
K091549 · MBI
Linvatec Corp.
Orthopedic · 27d
Cleared Jun 17, 2009
MAGNUM MP FIXATION DEVICE
K091503 · MBI
Arthrocare Corp.
Orthopedic · 27d
Cleared Jun 03, 2009
OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE
K090615 · MBI
Arthrocare Corp.
Orthopedic · 86d
Cleared May 20, 2009
SPIN-LOC SUTURE ANCHOR SYSTEM FG-0302-01,FG-0305-01
K090530 · MBI
Ross Creek Medical, Inc.
Orthopedic · 82d
Cleared Mar 13, 2009
MAGNUM M FIXATION DEVICE
K090380 · MBI
Arthrocare Corp.
Orthopedic · 24d
Cleared Mar 06, 2009
KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE
K083609 · MBI
Kfx Medical
Orthopedic · 88d
Cleared Mar 06, 2009
PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258
K090075 · MBI
Parcus Medical, LLC
Orthopedic · 53d
Cleared Jan 30, 2009
SMITH & NEPHEW PEEK INTERFERENCE SCREW
K083226 · MBI
Smith & Nephew Endoscopy, Inc.
Orthopedic · 88d