15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS)
FDA 510(k)
FDA Class 2
·Ophthalmic
ENTROPY EASYFIT SENSOR
FDA 510(k)
FDA Class 2
·Neurology
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·January 20, 2003
HYDRO X-FLOW CATHETER SILICONE WITH HYDROGEL COATING
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code EZL·January 4, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 6, 2025
PS FEMORAL COMPONENT CLOSED BOX LGE RIGHT 74 MM CEMENTED
FDA Adverse Event
Malfunction
·BIOMET SPAIN, S.L.·Product code JWH·June 3, 2020
AMISTEM H CEMENTLESS STEM SIZE 1 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 10, 2015
TM MONOBLOCK TIBIA
FDA Adverse Event
Injury
·ZIMMER TMT·Product code JWH·May 29, 2013
CONFIRM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code MXC·January 13, 2014
EXTENSION SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 28, 2011
PERF CON TIB BRG LRG 22X60
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020
NON-POROUS PERF TIB TRAY-LGE
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020
PERF ANAT TIBIAL STEM 120X14X5
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020
PKG, MIXTER FORCEPS, P/N 0250080285. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014