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"
73–96 of 149
Search insights Median review: 128d Cleared: 100% Top manufacturer: Implantcast GmbH Lead specialty: Orthopedic
Cleared Jun 27, 2023
VADER® Pedicle System Navigated Instruments
K230861 · OLO
Icotec AG
Orthopedic · 90d
Cleared Jun 26, 2023
Bone Bolt System
K230867 · HWC
University of Utah, Department of...
Orthopedic · 89d
Cleared Jun 23, 2023
PERLA® TL System
K230774 · PML
Spineart
Orthopedic · 94d
Cleared Jun 20, 2023
BethaLoc® stem cementless HA
K223103 · LZO
Implantcast GmbH
Orthopedic · 263d
Cleared Apr 19, 2023
SimpliFix Hip System
K230053 · HWC
Stabiliz Orthopaedics, Inc.
Orthopedic · 103d
Cleared Apr 04, 2023
BRM Digitalis Spacer
K220142 · KYJ
Brm Extremities Srl
Orthopedic · 441d
Cleared Mar 17, 2023
SMR Stemless Anatomic
K221758 · PKC
Lima Corporate S.P.A.
Orthopedic · 274d
Cleared Mar 06, 2023
Pro-X1™ Trochanteric Nailing System
K221621 · HSB
X-Bolt Orthopedics
Orthopedic · 276d
Cleared Jan 09, 2023
VADER® Pedicle System, G21 Cement
K222789 · PML
Icotec AG
Orthopedic · 116d
Cleared Jan 05, 2023
REMEDY Stemmed Knee Spacer
K223650 · JWH
Osteoremedies, LLC
Orthopedic · 30d
Cleared Dec 23, 2022
OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm
K221193 · HWC
OSSIO , Ltd.
Orthopedic · 242d
Cleared Dec 23, 2022
Episealer Patellofemoral System
K221048 · KRR
Episurf Medical, Inc.
Orthopedic · 259d
Cleared Dec 16, 2022
BRM TOOL Screws, BIOPLAN Subtalar Implant
K222820 · HWC
Brm Extremities
Orthopedic · 88d
Cleared Dec 01, 2022
Bolt Navigation System
K213768 · OWB
Circinus Medical Technology, LLC
Radiology · 365d
Cleared Nov 22, 2022
BioPoly Lesser Toe Hemiarthroplasty Implant
K222964 · KWD
BioPoly, LLC
Orthopedic · 56d
Cleared Oct 15, 2022
CONDUIT Cages
K222276 · ODP
Depuy Spine
Orthopedic · 78d
Cleared Oct 14, 2022
Shoulder PacemakerTM
K220994 · IPF
Ncs Lab Srl
Physical Medicine · 193d
Cleared Oct 03, 2022
SILO TFX MIS Sacroiliac Joint Fixation System
K221047 · OUR
Aurora Spine, Inc.
Orthopedic · 178d
Cleared Sep 28, 2022
AGILON XO Shoulder System
K222482 · KWT
Implantcast GmbH
Orthopedic · 42d
Cleared Sep 23, 2022
Platform® Acetabular System
K220483 · LZO
Total Joint Orthopedics, Inc.
Orthopedic · 217d
Cleared Sep 09, 2022
PointCore Surgical Mask
K220944 · FXX
Pointcore, Inc.
General Hospital · 162d
Cleared Sep 06, 2022
EMPHASYS Acetabular System
K221636 · LPH
Depuy Ireland UC
Orthopedic · 92d
Cleared Aug 19, 2022
prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
K221848 · QLQ
Centinel Spine, LLC
Orthopedic · 56d
Cleared Aug 17, 2022
implaFit® hip stems
K210678 · LZO
Implantcast GmbH
Orthopedic · 530d