12 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MENISCAL CINCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NOBELREPLACE CC PMC RP 4.3X10MM
FDA Adverse Event
Injury
·NOBEL BIOCARE USA INC·Product code DZE·June 15, 2021
NOBELPARALLEL CC NP 3.75X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·March 8, 2021
NOBELPARALLEL CC NP 3.75X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·March 8, 2021
FIRSTLINE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE-STEEL BLUE COLOR)
FDA 510(k)
FDA Class 1
·General Hospital
ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LAVA C.O.S. POWDER
FDA Adverse Event
Injury
·3M ESPE DENTAL PRODUCTS·Product code NOF·March 16, 2012
ARCHITECT HAVAB-G
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code LOL·April 23, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 25, 2011
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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