14 results
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21ms
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Sources: EU EUDAMED, US FDA
PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
L-25 ABSORBABLE SURIGCAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LAMBDA IMMAGE FREELITE KIT
FDA 510(k)
FDA Class 2
·Immunology
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 23, 2013
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 13, 2011
CHECK-FLO SHEATH INTRODUCER SET
FDA Adverse Event
Injury
·COOK, INC.·Product code DYB·July 9, 2008
BIOMET ARCOM 3 PEG/POST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 8, 2018
VANGUARD TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 8, 2018
VANGUARD FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 8, 2018
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code DZI·October 6, 2020
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code DZI·July 15, 2025
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code ELC·September 9, 2016
Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 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