FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

91 results for "Empirical Testing Corp"
73–91 of 91
Search insights Median review: 108d Cleared: 100% Top manufacturer: Corelink, LLC Lead specialty: Orthopedic
Cleared Oct 23, 2017
Acapella Cervical Spacer System
K171489 · OVE
Choicespine, LP
Orthopedic · 154d
Cleared Jun 21, 2017
Terrace™ Anterior Cervical Plate System
K163104 · KWQ
Corelink, LLC
Orthopedic · 226d
Cleared May 04, 2017
Foundation 3D Interbody
K162496 · ODP
Corelink, LLC
Orthopedic · 239d
Cleared Mar 10, 2017
CAVUX CervicalCage-L SA System
K163474 · OVE
Providence Medical Technology, Inc.
Orthopedic · 88d
Cleared Nov 28, 2016
AccuFit Lateral Plate System
K162211 · KWQ
Precision Spine, Inc.
Orthopedic · 112d
Cleared Nov 22, 2016
Reform® POCT System
K162300 · NKG
Precision Spine, Inc.
Orthopedic · 98d
Cleared Jun 28, 2016
Gibralt® Spine System and Gibralt® Occipital Spine System
K160697 · NKG
Exactech, Inc.
Orthopedic · 106d
Cleared Apr 13, 2016
Diplomat® Spinal System
K151704 · NKB
Signus Medizintechnik GmbH
Orthopedic · 294d
Cleared Feb 04, 2016
The Entasis Dual-Lead Sacroiliac Implant
K152237 · OUR
Corelink, LLC
Orthopedic · 178d
Cleared Aug 07, 2015
Precision Spine Interspinous Plate System
K151863 · PEK
Precision Spine, Inc.
Orthopedic · 30d
Cleared Jul 17, 2015
A-CIFT SoloFuse
K151198 · OVE
Spinefrontier, Inc.
Orthopedic · 73d
Cleared May 28, 2015
Ascendant TM Cervical Spacer System
K150130 · ODP
Exactech, Inc.
Orthopedic · 127d
Cleared May 13, 2015
SpineFrontier Lumbar Interbody Fusion Device System
K142504 · MAX
Spinefrontier, Inc.
Orthopedic · 250d
Cleared May 11, 2015
The Octane Straight Intervertebral Fusion Device, Ti Coated
K150152 · MAX
Exactech, Inc.
Orthopedic · 108d
Cleared Apr 24, 2015
SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
K150017 · OUR
Spinefrontier, Inc.
Orthopedic · 109d
Cleared Apr 02, 2015
Reliance Interspinous Plate System
K142217 · PEK
Reliance Medical Systems, LLC
Orthopedic · 233d
Cleared Feb 27, 2015
Exactech Ambassador
K143576 · KWQ
Exactech, Inc.
Orthopedic · 72d
Cleared Feb 12, 2015
PedFuse Pedicle Screw System
K143377 · MNH
Spinefrontier, Inc.
Orthopedic · 79d
Cleared Dec 18, 2014
Interspinous Plate System
K142378 · PEK
Precision Spine, Inc.
Orthopedic · 114d