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
313–336 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Aug 13, 2014
ARTHREX FIBERTAK SUTURE ANCHOR
K140476 · MBI
Arthrex, Inc.
Orthopedic · 168d
Cleared Jul 30, 2014
G-FORCE GEN 2 SUTURE ANCHOR SYSTEM
K141011 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 103d
Cleared Jul 24, 2014
PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE...
K141711 · MBI
Pontis Orthopaeeics, LLC
Orthopedic · 29d
Cleared Jul 21, 2014
BIOSURE HEALICOIL PK INTERFERENCE SCREW
K140879 · MBI
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Jul 07, 2014
RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL
K140324 · MBI
Depuy Mitek, A Johnson and Johnson...
Orthopedic · 147d
Cleared Jun 26, 2014
MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS
K133579 · MBI
Pontis Orthopaedics, LLC
Orthopedic · 217d
Cleared May 20, 2014
ACUMED SUTURE ANCHOR SYSTEM
K140925 · MBI
Acumed, LLC
Orthopedic · 39d
Cleared May 14, 2014
MULTIFIX S KNOTLESS FIXATION SYSTEM
K140604 · MBI
ArthroCare Corporation
Orthopedic · 65d
Cleared Apr 17, 2014
ICONN ANSWER SUTURE ANCHOR
K132724 · MBI
Iconn Orthopedics, LLC
Orthopedic · 230d
Cleared Apr 07, 2014
THREADED PEEK K-WIRE
K133235 · MBI
Mtp Solutions, LLC
Orthopedic · 168d
Cleared Apr 04, 2014
TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR
K133777 · MBI
Tornier, Inc.
Orthopedic · 113d
Cleared Apr 01, 2014
N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE...
K133606 · MBI
ArthroCare Corporation
Orthopedic · 127d
Cleared Mar 10, 2014
ACUMED SUTURE ANCHOR SYSTEM
K133469 · MBI
Acumed, LLC
Orthopedic · 118d
Cleared Mar 06, 2014
APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
K133036 · MBI
Amendia, Inc.
Orthopedic · 161d
Cleared Feb 28, 2014
ICONIX ALL SUTURE ANCHORS
K133671 · MBI
Stryker Corp.
Orthopedic · 91d
Cleared Feb 04, 2014
GFS II STANDARD, GFS II LARGE, GFS MIMI
K133757 · MBI
Parcus Medical, LLC
Orthopedic · 55d
Cleared Jan 30, 2014
TITANIUM SUTURE ANCHOR
K133229 · MBI
Mtp Solutions, LLC
Orthopedic · 101d
Cleared Jan 16, 2014
Q-FIX SUTURE ANCHOR, 1.8MM
K133727 · MBI
ArthroCare Corporation
Orthopedic · 41d
Cleared Jan 03, 2014
Y-KNOT RC ALL-SUTURE ANCHOR, 2.8MM - DOUBLE LOADED AND TRIPLE LOADED W/ #2...
K133224 · MBI
Conmed Corporation
Orthopedic · 74d
Cleared Dec 30, 2013
SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR...
K132867 · MBI
Cayenne Medical, Inc.
Orthopedic · 108d
Cleared Dec 09, 2013
EXOSHAPE DUO SOFT TISSUE FASTENER
K132783 · MBI
MedShape, Inc.
Orthopedic · 94d
Cleared Dec 05, 2013
POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE
K130467 · MBI
MedShape, Inc.
Orthopedic · 283d
Cleared Oct 18, 2013
NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS
K122437 · MBI
Biomet Sports Medicine
Orthopedic · 434d
Cleared Oct 16, 2013
A.I.M. SUTURE ANCHOR
K132461 · MBI
Anchor Innovation Medical, Inc.
Orthopedic · 70d