15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SA-3000P
FDA 510(k)
FDA Class 2
·Cardiovascular
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TCI-31 LIFELONG OVULATION TESTER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WAVEWRITER ALPHA PRIME
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 18, 2024
D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·February 27, 2014
D903 DIDECO AVANT 2 VAVD PHISIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·February 19, 2014
IT PADOVA
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·August 8, 2013
D903 DIDECO AVANT VAVD PHISIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·August 16, 2013
ADAPTA
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·April 23, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 1, 2011
INTEGRITY SR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·July 11, 2008
C20441 IL HAIFA
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DWF·March 28, 2012
MESH - COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC.·Product code FTL·June 14, 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 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