FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: MBI ×
599 results
121–144 of 599
Search insights Median review: 81d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Jul 29, 2022
S-Core Implant System
K220901 · MBI
Subchondral Solutions, Inc.
Orthopedic · 123d
Cleared Jul 26, 2022
Parcus Synd-EZ SS
K221502 · MBI
Parcus Medical, LLC
Orthopedic · 64d
Cleared Jul 11, 2022
Mitek TIGHT-N Anchor
K221364 · MBI
Medos International SARL
Orthopedic · 61d
Cleared Jun 08, 2022
FairFix AM Adjustable Button FairFix PSP Adjustable Button
K221389 · MBI
Medacta International S.A.
Orthopedic · 26d
Cleared May 19, 2022
X-Twist PEEK Suture Anchor
K221135 · MBI
Parcus Medical, LLC
Orthopedic · 30d
Cleared May 13, 2022
Argo Knotless SP Anchor
K220757 · MBI
Conmed Corporation
Orthopedic · 59d
Cleared Apr 15, 2022
FootHold System
K220797 · MBI
Crossroads Extremity Systems, LLC
Orthopedic · 28d
Cleared Dec 06, 2021
VersaTap, VersaLat, DueLock, VersaTi, MiniTi
K212381 · MBI
Ortho-Design (Pty), Ltd.
Orthopedic · 126d