27 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
FDA 510(k)
FDA Unclassified
·Unknown
MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 10 MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code NPJ·August 12, 2020
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486000783·MCK Onlay Tibia Baseplate
Jumbo
FDA UDI
CENTRIX, INC.·00817051021942·JUMBO TUBE STARTER KIT
SSW CARBIDE GREAT WHITE
FDA UDI
Ss White Burs, Inc.·D6901806152·GREAT WHITE GOLD CARBIDE GW1 - 5 PACK
Best Medical International
FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365108228·
MAKO UKR X3 ONLAY INSERT SIZE 5 - 8 MM
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code NPJ·April 20, 2021
ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)
FDA 510(k)
FDA Class 2
·Orthopedic
ARSTASIS ACCESS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN MAKO ONLAY TUBE INSERT 010370
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code OLO·October 6, 2021
TIBIA INST-VITAMIN E-ONLAY SIZE5-8MM
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code NPJ·May 25, 2017
MAKO UKR X3 ONLAY INSERT SIZE 5 - 8 MM
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code NPJ·February 10, 2025
MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 9 MM
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code NPJ·August 29, 2018
SYRINGE, LUER LOCK, STERILE, 20ML
FDA Adverse Event
Malfunction
·MEDLINE INDUSTRIES, LP·Product code FMF·April 1, 2024
MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 8 MM
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code NPJ·August 5, 2019
MAKO UKR X3 ONLAY INSERT SIZE 5 - 8 MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code NPJ·January 11, 2022
Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm 30¿ is a sharp pointed tip intended for ophthalmic, ENT and other forms of surgery stab incisions and other microsurgical techniques. .
FDA Enforcement
Class III
·Terminated·Beaver Visitec·April 10, 2019
VICTORY XL DR
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·June 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
AUTO LUBE SYSTEM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GEI·October 17, 2014