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
121–144 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Mar 22, 2023
Stativ® Knotted UHMWPE Suture Anchor
K223889 · MBI
Healthium Medtech Limited
Orthopedic · 85d
Cleared Mar 17, 2023
Aevumed RAPID Suture Anchors
K223878 · MBI
Aevumed, Inc.
Orthopedic · 80d
Cleared Mar 10, 2023
Arthrex Knotless FiberTak Suture Anchor
K230433 · MBI
Arthrex, Inc.
Orthopedic · 21d
Cleared Mar 08, 2023
SINEFIX
K220966 · MBI
BAAT Medical Products B.V.
Orthopedic · 341d
Cleared Mar 03, 2023
Grappler Suture Anchor R3FLEX IOL System
K223589 · MBI
Paragon 28, Inc.
Orthopedic · 92d
Cleared Feb 24, 2023
MectaLock TI Triple Loaded Suture Anchor
K223582 · MBI
Medacta International S.A.
Orthopedic · 85d
Cleared Feb 23, 2023
OrthoButton AL
K230212 · MBI
Riverpoint Medical, LLC
Orthopedic · 28d
Cleared Feb 17, 2023
ULTRABUTTON QUAD Adjustable Fixation Device
K222971 · MBI
Smith & Nephew, Inc.
Orthopedic · 143d
Cleared Feb 04, 2023
Simparo Anchor Line Fixation System
K222574 · MBI
Simparo, Inc.
Orthopedic · 163d
Cleared Feb 02, 2023
SutureLoc™ Implant
K223284 · MBI
Arthrex, Inc.
Orthopedic · 100d
Cleared Jan 26, 2023
Flexible Suturing System with Anchors (FSSA)
K222589 · MBI
Integrity Orthopaedics, Inc.
Orthopedic · 153d
Cleared Jan 17, 2023
FairFix QT Adjustable Button
K223795 · MBI
Medacta International S.A.
Orthopedic · 29d
Cleared Dec 22, 2022
Arthrex FiberTak Suture Anchor
K221396 · MBI
Arthrex, Inc.
Orthopedic · 223d
Cleared Dec 16, 2022
AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA...
K213110 · MBI
Auxein Medical Private Limited
Orthopedic · 448d
Cleared Nov 28, 2022
Aevumed PHANTOM™-LP Suture Anchors
K222363 · MBI
Aevumed, Inc.
Orthopedic · 116d
Cleared Nov 18, 2022
Auxilock GFS Mini, GFS II Large, and GFS Ultimate
K213018 · MBI
Auxein Medical Private Limited
Orthopedic · 424d
Cleared Oct 13, 2022
Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors
K222763 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 30d
Cleared Sep 22, 2022
WasherCap Fixation System
K212197 · MBI
Abanza Tecnomed S.L
Orthopedic · 435d
Cleared Sep 14, 2022
Grappler Suture Anchor System
K222091 · MBI
Paragon 28, Inc.
Orthopedic · 61d
Cleared Sep 07, 2022
FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire,...
K221731 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 84d
Cleared Aug 22, 2022
Auxilock Draw Tight Suture-Based Anchor
K213109 · MBI
Auxein Medical Private Limited
Orthopedic · 332d
Cleared Aug 16, 2022
FairFix Adjustable Button System
K222169 · MBI
Medacta International S.A.
Orthopedic · 26d
Cleared Aug 11, 2022
Arthrex Knotless FiberTak Biceps Suture Anchor
K222161 · MBI
Arthrex, Inc.
Orthopedic · 22d
Cleared Jul 29, 2022
Auxilock Titanium Screw-In Suture Anchor
K213104 · MBI
Auxein Medical Private Limited
Orthopedic · 308d