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
529–552 of 599
Search insights Median review: 81d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Dec 01, 1997
ACL CLIP-IN
K973323 · MBI
Innovasive Devices, Inc.
Orthopedic · 88d
Cleared Nov 10, 1997
MITEK NON ABSORBABLE POLYPROPYLENE H FIX
K973009 · MBI
Mitek Products
Orthopedic · 89d
Cleared Oct 28, 1997
CSCO FOREHEAD FIXATION SYSTEM
K963502 · MBI
Howmedica Corp.
Orthopedic · 420d
Cleared Oct 09, 1997
STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K972622 · MBI
Influence, Inc.
Orthopedic · 87d
Cleared Oct 09, 1997
MULTITAK SS SUTURE SYSTEM
K973015 · MBI
Bonutti Research
Orthopedic · 57d
Cleared Sep 26, 1997
INNOVASIVE 2.3MM ROC XS SUTURE BONE FASTENER
K972438 · MBI
Innovasive Devices, Inc.
Orthopedic · 88d
Cleared Aug 26, 1997
INNOVASIVE 2.3MM ROC EZ SUTURE BONE FASTENER
K972356 · MBI
Innovasive Devices, Inc.
Orthopedic · 62d
Cleared Aug 07, 1997
INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER
K971922 · MBI
Innovasive Devices, Inc.
Orthopedic · 76d