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
73–96 of 599
Search insights Median review: 81d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Dec 28, 2023
SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant
K230891 · MBI
Healthium Medtech Limited
Orthopedic · 272d
Cleared Dec 26, 2023
Suture Wing
K233659 · MBI
Osteonic Co., Ltd.
Orthopedic · 41d
Cleared Dec 07, 2023
OTS 25 (100-1)
K233429 · MBI
Ots Medical , Ltd.
Orthopedic · 57d
Cleared Nov 30, 2023
IDEAL Ziploop
K233552 · MBI
Riverpoint Medical
Orthopedic · 27d
Cleared Nov 15, 2023
Arthrex Knee FiberTak® Button Suture Anchor
K232973 · MBI
Arthrex, Inc.
Orthopedic · 55d
Cleared Nov 14, 2023
Iconix Anchor
K233468 · MBI
Riverpoint Medical
Orthopedic · 21d
Cleared Nov 08, 2023
INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
K232886 · MBI
Healthium Medtech Limited
Orthopedic · 51d
Cleared Nov 03, 2023
Arthrex FiberTak Suture Anchor
K232742 · MBI
Arthrex, Inc.
Orthopedic · 57d
Cleared Nov 02, 2023
Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor
K232725 · MBI
Suzhou Endophix Co., Ltd.
Orthopedic · 57d
Cleared Oct 24, 2023
Knotilus+ PEEK Knotless Anchor
K232683 · MBI
Stryker Endoscopy
Orthopedic · 53d
Cleared Oct 23, 2023
Shadow Knotless All-Suture Anchors
K233258 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 25d
Cleared Oct 06, 2023
JuggerKnot Soft Anchor OC
K232411 · MBI
Riverpoint Medical, LLC
Orthopedic · 57d
Cleared Oct 06, 2023
2.7 mm GRYPHON™ Flex Knotless PEEK Anchor
K232492 · MBI
Medos International SARL
Orthopedic · 50d
Cleared Oct 05, 2023
All-Suture Anchor
K231078 · MBI
Riverpoint Medical, LLC
Orthopedic · 171d
Cleared Sep 20, 2023
CITRELOCK® DUO
K232592 · MBI
Acuitive Technologies, Inc.
Orthopedic · 26d
Cleared Sep 11, 2023
Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture...
K230517 · MBI
Jarmon Medical, LLC (Dba Legends...
Orthopedic · 196d
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