13 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPERM CRYOPROTEC
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Angled Tip
FDA UDI
COOK INCORPORATED·00827002145887·Angled Tip Ureteral Catheter Set With Bentson P...
Easydrip Plus Pen Needles
FDA UDI
Sandstone Medical (Suzhou) Inc.·16972857294745·
IMMULITE 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018
GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
FDA 510(k)
FDA Class 2
·Radiology
TINA-QUANT APOLIPOPROTEIN B VER.2
FDA 510(k)
FDA Class 2
·Immunology
IMMULITE 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018
RESTORE
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·March 27, 2013
SHILEY PEDIATRIC CUFFED LONG
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code JOH·March 15, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008
Advisor Vital Signs Monitor (model 9200), catalog number 925654320, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 60 Hz ECG, standard SPO2 option and Invasive Pressure/Temperature option.
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DPS·September 1, 2005
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