13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
POWER SUPPLY / BATTERY CHARGER
FDA Adverse Event
Malfunction
·ELPAC·Product code IYN·March 28, 2011
POWER SUPPLY/BATTERY CHARGER
FDA Adverse Event
Malfunction
·ELPAC·Product code ITX·July 30, 2010
POWER SUPPLY/BATTERY CHARGER
FDA Adverse Event
Malfunction
·ELPAC·Product code ITX·June 25, 2010
AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP
FDA 510(k)
FDA Class 3
·Cardiovascular
MODIFICATION TO: QWH-420 WRIST ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
PFC*SIGMA/RD/DOME PAT 3PEG,35
FDA Adverse Event
Injury
·JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.·Product code JWH·April 11, 2013
COMMUNICATOR
FDA Adverse Event
Malfunction
·EXTERNAL MANUFACTURER·Product code LWS·April 13, 2011
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code FGE·May 22, 2008
TEXIUM CLOSED MALE LUER WITH FEMAILE CAP
FDA Adverse Event
Malfunction
·CAREFUSION NORTH CAROLINA·Product code FPA·July 6, 2020
SELECT 1.5
FDA Adverse Event
Injury
·EMPI, INC.·Product code GZJ·April 26, 2011
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