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
97–120 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Sep 08, 2023
Q-FIX ULTRA All-Suture Anchor
K232457 · MBI
Smith & Nephew
Orthopedic · 25d
Cleared Sep 01, 2023
Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor
K232340 · MBI
Arthrex, Inc.
Orthopedic · 28d
Cleared Aug 30, 2023
AlphaVent Suture Anchors
K231093 · MBI
Stryker Endoscopy
Orthopedic · 134d
Cleared Aug 25, 2023
Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors
K230094 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 225d
Cleared Aug 21, 2023
Grappler Suture Anchor System
K231867 · MBI
Paragon 28, Inc.
Orthopedic · 56d
Cleared Aug 09, 2023
Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles,...
K231376 · MBI
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Aug 08, 2023
Arthrex TightRope II
K231857 · MBI
Arthrex, Inc.
Orthopedic · 46d
Cleared Aug 04, 2023
T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button,...
K231404 · MBI
Healthium Medtech Limited
Orthopedic · 81d
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