13 results
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20ms
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Sources: EU EUDAMED, US FDA
PLAIN AND CHROMIC GUT SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Brigade
FDA UDI
Nuvasive, Inc.·00887517964359·Brigade Lateral Trial, 15x34x24mm 12°
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 26, 2020
REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY POWER CORD, MODEL V5100-00,V5701-00,V5702
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OPTISCAN MODEL OPTISCAN CEIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TL PLUS FULL RING, 160MM
FDA Adverse Event
Injury
·ORTHOFIX SRL·Product code LXT·May 6, 2021
TL PLUS FULL RING, 160MM
FDA Adverse Event
Injury
·ORTHOFIX SRL·Product code LXT·May 6, 2021
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code LWS·July 9, 2015
UNIFY ASSURA DR CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 30, 2014
UNKNOWN IVS TUNNELLER DEVICE
FDA Adverse Event
Injury
·BALLYMONEY - USS·Product code FTL·January 3, 2013
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 14, 2013
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 8, 2013
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