FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

149 results for "Mcra, LLC"
121–144 of 149
Search insights Median review: 128d Cleared: 100% Top manufacturer: Implantcast GmbH Lead specialty: Orthopedic
Cleared Oct 15, 2020
icotec Anterior Cervical Plate System
K201587 · KWQ
Icotec AG
Orthopedic · 126d
Cleared Oct 07, 2020
Fortilink Cages with TiPlus Technology
K201453 · MAX
Paradigm Spine GmbH
Orthopedic · 128d
Cleared Aug 13, 2020
IlluminOss Photodynamic Bone Stabilization System
K201961 · QAD
Illuminoss Medical, Inc.
Orthopedic · 30d
Cleared Aug 04, 2020
CoFix System
K201704 · PEK
Paradigm Spine GmbH
Orthopedic · 43d
Cleared Jul 30, 2020
OSSIOfiber™ Compression Screws
K193660 · HWC
OSSIO , Ltd.
Orthopedic · 213d
Cleared Jul 17, 2020
Phantom® Hindfoot TTC/TC Nail System
K201227 · HSB
Paragon 28, Inc.
Orthopedic · 72d
Cleared Jul 10, 2020
Paragon 28 APEX 3D Total Ankle Replacement System
K192994 · HSN
Paragon 28, Inc.
Orthopedic · 259d
Cleared Jul 02, 2020
Luna XD Ti Interbody Fusion System
K193172 · MAX
Benvenue Medical, Inc.
Orthopedic · 230d
Cleared Jun 25, 2020
Lever Action Plate System
K200834 · HRS
Mcginley Orthpaedic Innovations, LLC
Orthopedic · 87d
Cleared Jun 18, 2020
Medussa-PL Cage
K200283 · MAX
Medyssey USA, Inc.
Orthopedic · 135d
Cleared Apr 24, 2020
SPIRA-C Integrated Fixation System
K193153 · OVE
Camber Spine Technologies
Orthopedic · 163d
Cleared Mar 20, 2020
icotec Cervical Cage
K192897 · ODP
Icotec AG
Orthopedic · 161d
Cleared Feb 14, 2020
Dunamis PunchTac Suture Anchors
K193245 · MBI
Dunamis, LLC
Orthopedic · 81d
Cleared Feb 13, 2020
NewPrim System
K191966 · KWH
Brm Extremities
Orthopedic · 205d
Cleared Jan 14, 2020
Streamline TL Spinal Fixation System
K192800 · NKB
Pioneer Surgical Technology, Inc....
Orthopedic · 106d
Cleared Jan 10, 2020
OsteoRemedies Hip Spacer System
K192995 · KWL
Osteoremedies, LLC
Orthopedic · 77d
Cleared Oct 22, 2019
Madison Total Knee System
K192084 · JWH
Implanet, S.A.
Orthopedic · 81d
Cleared Aug 29, 2019
Dunamis Fixation Button System
K191319 · MBI
Dunamis, LLC
Orthopedic · 106d
Cleared Aug 28, 2019
Implantcast ic-Bipolar Head System
K191569 · KWY
Implantcast GmbH
Orthopedic · 76d
Cleared Aug 23, 2019
REMEDY Acetabular Cup
K191981 · KWL
Osteoremedies, LLC
Orthopedic · 30d
Cleared Jun 10, 2019
AccuFill Bone Substitute Material
K190814 · MQV
Zimmer Knee Creations
Orthopedic · 73d
Cleared Apr 11, 2018
Rafugen DBM
K180121 · MQV
Cellumed Co., Ltd.
Orthopedic · 85d
Cleared Sep 15, 2017
Ti-Diagon Oblique TLIF
K172064 · MAX
Camber Spine Technologies
Orthopedic · 70d
Cleared Jul 13, 2017
Coveris Cervical Cage System
K170550 · ODP
Camber Spine Technologies
Orthopedic · 139d