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Mako Surgical Corporation

17 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: recall (Z-0472-2021)Mako Surgical Corporation2020-11-19
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167 recall (Z-2745-2020)Mako Surgical Corporation2020-07-31
Stryker Mako Vizadisc Knee Procedure Tracking Kit recall (Z-2924-2018)Mako Surgical Corporation2018-08-24
Stryker Mako Vizadisc Hip Procedure Tracking Kit recall (Z-2925-2018)Mako Surgical Corporation2018-08-24
Restoris MCK Onlay Insert Extractor. recall (Z-2051-2018)Mako Surgical Corporation2018-06-01
Robotic Arm Interactive Orthopedic System (RIO) recall (Z-1508-2016)Mako Surgical Corporation2016-04-18
Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# recall (Z-0224-2016)Mako Surgical Corporation2015-11-05
Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Intera recall (Z-1128-2015)Mako Surgical Corporation2015-02-19
RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use recall (Z-0828-2015)Mako Surgical Corporation2014-12-18
RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument desi recall (Z-0829-2015)Mako Surgical Corporation2014-12-18
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument design recall (Z-0830-2015)Mako Surgical Corporation2014-12-18
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used wit recall (Z-1132-2014)Mako Surgical Corporation2014-03-04
The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist th recall (Z-0385-2013)Mako Surgical Corporation2012-11-19
Labeling for RIO Robot Unit is comprised of three main components: 20399 RIO SURGICAL ARM, recall (Z-0146-2012)Mako Surgical Corporation2011-11-01
MAKO PN 204588 Camera 204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX 2011-0 recall (Z-2232-2011)Mako Surgical Corporation2011-05-20
200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance Mod recall (Z-0064-2010)Mako Surgical Corporation2009-10-19
Tibial Array and Femoral Array. Model Number(s): 0150ARR00001 and 0150ARR00002. Manufactur recall (Z-0915-2009)Mako Surgical Corporation2009-02-11

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Every clearance here is in the API, with alerts when new ones post.