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

60 results for "MRC Global, LLC"
25–48 of 60
Search insights Median review: 107d Cleared: 100% Top manufacturer: FH Industrie Lead specialty: Orthopedic
Cleared Apr 16, 2024
Alcantara Thoracolumbar Plate System
K232256 · KWQ
Camber Spine Technologies, LLC
Orthopedic · 263d
Cleared Jan 12, 2024
BEE Cervical Cage
K231371 · ODP
NGMedical GmbH
Orthopedic · 245d
Cleared Dec 21, 2023
SkyOPS™ Orthopedic Plate System
K233154 · HRS
Sky Surgical, LLC
Orthopedic · 85d
Cleared Oct 10, 2023
Zeus Spinal System
K230961 · NKB
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 188d
Cleared Sep 29, 2023
SafeBreak® Vascular
K231957 · QOI
Lineus Medical
General Hospital · 88d
Cleared Aug 29, 2023
ARROW Off-Centred Humeral Insert
K232226 · PHX
FH Industrie
Orthopedic · 33d
Cleared May 19, 2023
SafeBreak® Vascular
K223486 · QOI
Lineus Medical
General Hospital · 179d
Cleared May 12, 2023
SOMAVAC® 100 Sustained Vacuum System
K231063 · BTA
Somavac Medical Solutions, Inc.
General & Plastic Surgery · 28d
Cleared Mar 30, 2023
ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)
K221324 · OVD
Camber Spine Technologies
Orthopedic · 328d
Cleared Mar 23, 2023
Swedge™ Pedicle Screw Fixation System
K230482 · NKB
Spinal Resources, Inc.
Orthopedic · 29d
Cleared Nov 17, 2022
Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
K221593 · EZD
Convatec, Inc.
Gastroenterology & Urology · 168d
Cleared Nov 15, 2022
2.1 x 255mm Drill, 22mm Stop
K223199 · HBE
Biomet Microfixation
Neurology · 33d
Cleared Nov 07, 2022
Lotus Prophy Angle
K220346 · EGS
Ajk Engineering, Inc.
Dental · 273d
Cleared Oct 19, 2022
SOMAVAC 100 Sustained Vacuum System
K222856 · BTA
Somavac Medical Solutions, Inc.
General & Plastic Surgery · 28d
Cleared Oct 16, 2022
SafeBreak Vascular
K222791 · QOI
Lineus Medical, LLC
General Hospital · 31d
Cleared Sep 30, 2022
e-Ortho Shoulder Software v1.1
K220758 · LLZ
FH Industrie
Radiology · 199d
Cleared Jun 06, 2022
Keos Anterior Cervical Interbody Fusion Device System
K212450 · ODP
Keos
Orthopedic · 305d
Cleared Apr 29, 2022
Camber Spine Navigation System
K220038 · OLO
Camber Spine Technologies
Orthopedic · 114d
Cleared Apr 22, 2022
RibFix Blu Thoracic Fixation System
K212608 · HRS
Biomet Microfixation
Orthopedic · 248d
Cleared Feb 16, 2022
Treace Medical Concepts (TMC) Plating System
K220136 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 29d
Cleared Jan 07, 2022
Pectus Blu Support Bar System
K212841 · HRS
Biomet Micofixation
Orthopedic · 122d
Cleared Dec 23, 2021
Twist Drills
K213208 · HBE
Biomet Microfixation
Neurology · 85d
Cleared Dec 06, 2021
CHENA-C Spacer System
K213115 · ODP
Kahtnu Surgical, Inc.
Orthopedic · 70d
Cleared Dec 01, 2021
NGM WAVE PLIF Cage
K212050 · MAX
NGMedical GmbH
Orthopedic · 154d