11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
FDA 510(k)
FDA Class 2
·Immunology
SCS CLOSED SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
VERTE-STACK K030736, K041197
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019
SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·June 17, 2021
ALLOCLASSIC VARIALL, SLV STEM, UNCEMENTED, 2, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·March 29, 2018
LEAVE ACTIVE PFC CVD 8MM SZ3
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code JWH·April 2, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 22, 2011
ACCU-CHEK ULTRAFLEX INFUSION SET
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·April 17, 2008
Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide, Rx Only,
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code LGW·March 1, 2008
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