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
481–504 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jul 14, 2006
OPUS LABRALOCK P KNOTLESS FIXATION DEVICE
K061349 · MBI
Arthrocare Corp.
Orthopedic · 60d
Cleared Jun 08, 2006
KINSA SUTURE ANCHOR
K061154 · MBI
Smith & Nephew, Inc.
Orthopedic · 43d
Cleared Feb 03, 2006
EZLOC FEMORAL FIXATION DEVICE
K053461 · MBI
Arthrotek, Inc.
Orthopedic · 52d
Cleared Dec 20, 2005
SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
K052810 · MBI
Scandius Biomedical, Inc.
Orthopedic · 77d
Cleared Dec 05, 2005
ANSPACH KNOTLESS ANCHOR
K052572 · MBI
The Anspach Effort, Inc.
Orthopedic · 77d
Cleared Oct 07, 2005
AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR
K052491 · MBI
Axya Medical, Inc.
Orthopedic · 25d
Cleared Jun 29, 2005
NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER
K051069 · MBI
Arthrotek, Inc.
Orthopedic · 64d
Cleared Mar 02, 2005
THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER
K050227 · MBI
Linvatec Corp.
Orthopedic · 29d
Cleared Nov 12, 2004
OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE
K042914 · MBI
Opus Medical, Inc.
Orthopedic · 22d
Cleared Oct 29, 2004
TI - SCREW ANCHOR SP
K042460 · MBI
Arthrotek, Inc.
Orthopedic · 49d
Cleared Jul 22, 2004
SUPER REVO HERCULINE SUTURE ANCHOR
K041713 · MBI
Linvatec Corp.
Orthopedic · 29d
Cleared Jun 25, 2004
OPUS MAGNUM ANCHOR WITH INSERTER
K041440 · MBI
Opus Medical, Inc.
Orthopedic · 24d
Cleared Jun 14, 2004
STRYKER WEDGE SUTURE ANCHOR SYSTEM
K041310 · MBI
Stryker Endoscopy
Orthopedic · 28d
Cleared Jun 07, 2004
FEMORAL HOOK
K041261 · MBI
Arthrotek, Inc.
Orthopedic · 27d
Cleared Feb 13, 2004
TITANIUM TOGGLE BUTTON(S)
K033838 · MBI
Biomet Manufacturing, Inc.
Orthopedic · 65d
Cleared May 05, 2003
ADHOC CLAW
K023963 · MBI
Future Medical Systems, Inc.
Orthopedic · 157d
Cleared Nov 25, 2002
ENDOTACK
K022853 · MBI
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 90d
Cleared Nov 22, 2002
ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
K022827 · MBI
Linvatec Corp.
Orthopedic · 88d
Cleared Oct 04, 2002
AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM
K022207 · MBI
Axya Medical, Inc.
Orthopedic · 88d
Cleared Jul 22, 2002
OPUS MAGNUM ANCHOR & INSTRUMENT SET
K020172 · MBI
Opus Medical, Inc.
Orthopedic · 186d
Cleared Dec 19, 2001
PRE-LOADED ULTRAFIX RC
K013553 · MBI
Linvatec Corp.
Orthopedic · 55d
Cleared Dec 13, 2001
ENDOFLIP
K013334 · MBI
Arthocare Corporation
Orthopedic · 65d
Cleared Nov 16, 2001
LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW
K013557 · MBI
Walter Lorenz Surgical, Inc.
Orthopedic · 23d
Cleared Oct 22, 2001
METAL SCREW ANCHOR
K012503 · MBI
Biomet Manufacturing, Inc.
Orthopedic · 80d