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
529–552 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Dec 16, 1998
POLYMER THREADED ANCHOR
K983169 · MBI
Orthopaedic Biosystems, Ltd.
Orthopedic · 97d
Cleared Nov 23, 1998
MITEK FASTIN RC ANCHOR
K983818 · MBI
Mitek Products
Orthopedic · 25d
Cleared Oct 13, 1998
INNOVASIVE TIBIAL FASTENER
K983056 · MBI
Innovasive Devices, Inc.
Orthopedic · 42d
Cleared Sep 22, 1998
KSEA FLIPPTACK
K982571 · MBI
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 60d
Cleared Sep 14, 1998
SHERLOCK THREADED SUTURE ANCHOR (TIN COATED)
K982169 · MBI
Doctor'S Research Group, Inc.
Orthopedic · 87d
Cleared Aug 31, 1998
SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K982155 · MBI
Influence, Inc.
Orthopedic · 74d
Cleared Aug 06, 1998
5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE...
K974847 · MBI
Arthrex, Inc.
Orthopedic · 220d
Cleared Jul 27, 1998
MENISCAL REPAIR DEVICE
K981692 · MBI
Linvatec Corp.
Orthopedic · 75d
Cleared Jul 17, 1998
WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW...
K981967 · MBI
Arthrotek/Biomet, Inc.
Orthopedic · 43d
Cleared Jul 13, 1998
ANSPACH SUTURE ANCHOR
K981688 · MBI
The Anspach Effort, Inc.
Orthopedic · 63d
Cleared Jul 13, 1998
LM ANCHOR
K981755 · MBI
Li Medical Technologies, Inc.
Orthopedic · 56d
Cleared Jul 13, 1998
LM ANCHOR
K981764 · MBI
Li Medical Technologies, Inc.
Orthopedic · 55d
Cleared Jun 16, 1998
INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER
K981193 · MBI
Innovasive Devices, Inc.
Orthopedic · 75d
Cleared May 11, 1998
DEPUY ORTHOTECH CATERA SUTURE ANCHOR
K980595 · MBI
DePuy Orthopaedics, Inc.
Orthopedic · 83d
Cleared Apr 29, 1998
INNOVASIVE LINX TIBIAL LIGAMENT FASTENER
K980491 · MBI
Innovasive Devices, Inc.
Orthopedic · 79d
Cleared Apr 27, 1998
INNOVASIVE 10MM LINX HT LIGAMENT FASTENER
K980334 · MBI
Innovasive Devices, Inc.
Orthopedic · 89d
Cleared Apr 24, 1998
ACL CLIP-IN PLATE
K973874 · MBI
Innovasive Devices, Inc.
Orthopedic · 196d
Cleared Apr 16, 1998
HARPOON SUTURE ANCHORS
K973775 · MBI
Biomet, Inc.
Orthopedic · 195d
Cleared Mar 16, 1998
ACUMED SUTURE ANCHOR
K980103 · MBI
Acu Med, Inc.
Orthopedic · 63d
Cleared Feb 18, 1998
INNOVASIVE LINX BT 10MM LIGAMENT FASTENER
K974049 · MBI
Innovasive Devices, Inc.
Orthopedic · 117d
Cleared Feb 13, 1998
MITEK KNOTLESS ANCHOR
K974345 · MBI
Mitek Products
Orthopedic · 86d
Cleared Feb 06, 1998
PEBA ANCHOR/SUTURE COMBINATION
K972326 · MBI
Orthopaedic Biosystems, Ltd.
Orthopedic · 228d
Cleared Jan 30, 1998
MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX
K970119 · MBI
Mitek Products
Orthopedic · 381d
Cleared Jan 30, 1998
CRANIOFACIAL ANCHORS
K974136 · MBI
Biomet, Inc.
Orthopedic · 88d