12 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BD SYRINGE 1ML S/T W/NDL 27X1/2 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 23, 2024
AVISTA MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 23, 2021
OMEGATRAC, MODEL Z105
FDA 510(k)
FDA Class 2
·Physical Medicine
DERMAGRIP POWDER FREE PINK POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL W
FDA 510(k)
FDA Class 1
·General Hospital
ASR ACETABULAR IMPLANT 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 23, 2013
ATTAIN ABILITY
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·May 1, 2011
VERITY ADX SR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·July 11, 2008
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 24, 2025
OLYMPUS ESG-100, 100...120 V~,
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code GEI·September 27, 2022
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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024