13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OSCAR 3
FDA 510(k)
FDA Class 2
·Orthopedic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450595121·
GYNECOLOGICAL LAPAROSCOPES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KOWA AUTOMATED TONOMETER KT-500
FDA 510(k)
FDA Class 2
·Ophthalmic
MEDACTA KNEE IMPLANTS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 28, 2016
TRILOGY 200
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code CBK·August 19, 2020
ALLEGRETTO WAVE
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·April 30, 2013
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·September 16, 2014
TAXUS (R) LIBERTÉ (R)
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·May 18, 2011
ARROW CVC KIT: 3-LUMEN 8,5FR X 20CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·March 3, 2026
Misys Laboratory with Lab Access Results application for versions 5.3 and later.
FDA Recall
Terminated
·Misys Healthcare Systems·Product code JQP·May 13, 2005
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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