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
97–120 of 599
Search insights Median review: 81d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Aug 04, 2023
HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue)
K232005 · MBI
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Aug 02, 2023
Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors
K223114 · MBI
Gm Dos Reis Industria E Comerico Ltda.
Orthopedic · 303d
Cleared Aug 01, 2023
Knotless Suture Anchor
K231278 · MBI
Riverpoint Medical, LLC
Orthopedic · 90d
Cleared Jun 07, 2023
Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot...
K231002 · MBI
Suzhou Endophix Co., Ltd.
Orthopedic · 61d
Cleared Jun 07, 2023
Fix2Lock(PEEK Self Punching)
K231322 · MBI
Osteonic Co., Ltd.
Orthopedic · 30d
Cleared Jun 01, 2023
FiberTak® Suture Anchor
K231330 · MBI
Arthrex, Inc.
Orthopedic · 24d
Cleared May 23, 2023
Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath
K230874 · MBI
Suzhou Endophix Co., Ltd.
Orthopedic · 54d
Cleared May 22, 2023
Integrity™ Bone Staple Fixation System
K223860 · MBI
Anika Therapeutics, Inc.
Orthopedic · 150d
Cleared May 18, 2023
Arthrex FiberTak Suture Anchor
K231113 · MBI
Arthrex, Inc.
Orthopedic · 29d
Cleared May 17, 2023
JuggerKnot Soft Anchor
K231128 · MBI
Riverpoint Medical, LLC
Orthopedic · 27d
Cleared May 03, 2023
Apollo Knotless Suture Anchor
K230123 · MBI
Maruho Medical
Orthopedic · 106d
Cleared May 03, 2023
PEEK RCI Screw
K230655 · MBI
Signature Orthopaedics Pty, Ltd.
Orthopedic · 55d
Cleared Apr 17, 2023
SnugFit All-Suture Anchor extension
K230544 · MBI
Medacta International S.A.
Orthopedic · 48d
Cleared Apr 01, 2023
FiberTak Suture Anchor
K230568 · MBI
Arthrex, Inc.
Orthopedic · 31d
Cleared Mar 23, 2023
Fixone All Suture Anchor
K222423 · MBI
Aju Pharm Co., Ltd.
Orthopedic · 224d
Cleared Mar 22, 2023
Tigon Medical Gryphon Anchor Line
K220464 · MBI
Tigon Medical
Orthopedic · 398d
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