10 results
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19ms
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Sources: EU EUDAMED, US FDA
Q-PLUS T
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
FDA 510(k)
FDA Class 2
·Hematology
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS
FDA 510(k)
FDA Class 2
·Dental
K-WIRE GAMMA 3,2X450 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·January 18, 2021
LINER AND SHELL WITH PLASTIC BARRIER 48 MM I.D. 60 MM O.D.
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 3, 2023
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 23, 2013
VANGUARD DCM CR TIBIAL BEARING 10MM X 63/67MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·May 2, 2011
RIATA ST OPTIM ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001933;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 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