19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ClearPath Aligner
FDA 510(k)
FDA Class 2
·Dental
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112922·CORNEAL TREPHINE BLADE7.75MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112502·BARRON VACUUM TREPHINE 7.75MM
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113462·SCLEROTOME BLADE #57 (BX/5)
PUMP TUBING WITH X-COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
ELS CANNULA (KIT), MODEL M1210-88,M1510-88
FDA 510(k)
FDA Class 2
·Cardiovascular
Z NAIL CMF 11.5MMX21.5CM 125 L
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·April 24, 2026
HIP END EFFECTOR, VARIABLE ANGLE
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·December 8, 2017
WALLSTENT-UNI ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIO·October 17, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·July 2, 2013
HIP END EFFECTOR, VARIABLE ANGLE
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·December 11, 2019
HIP END EFFECTOR, VARIABLE ANGLE
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·July 3, 2018
HIP END EFFECTOR, VARIABLE ANGLE
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·January 18, 2018
HIP END EFFECTOR, VARIABLE ANGLE
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·August 25, 2017
HIP END EFFECTOR, VARIABLE ANGLE
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·April 21, 2017
HIP END EFFECTOR, VARIABLE ANGLE
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·December 2, 2019
Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)
FDA Recall
Terminated
·Innovative Ophthalmic Products, Inc·Product code KYF·February 22, 2016
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012