14 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033234·Baltic Denture System BDLoad BDLoad Mw7 PLSEbi...
Ortho Organizers
FDA UDI
Ortho Organizers, Inc.·00190707023706·CNA PALATAL ARCH 34mm
NA
FDA UDI
STRYKER CORPORATION·04546540392206·90 Degree Angle Precision, Offset (5.5 x 0.64 x...
ENDOSCOPIC PLICATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICROJET CRONO
FDA 510(k)
FDA Class 2
·General Hospital
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 3, 2013
SPEEDBAND SUPERVIEW SUPER 7, MODELS 4203
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code MND·March 30, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 25, 2014
POLYMOBIL PLUS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE GMBH·Product code IZL·July 27, 2023
TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·May 30, 2019
TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·May 24, 2019
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024