12 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE
FDA 510(k)
FDA Class 2
·General Hospital
PLUM 4-PORT 15 FLTR 2CLV PE LINE 216CM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 27, 2013
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033576·Baltic Denture System BDLoad BDLoad Lm6 PLSEbi...
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MOR2000, PCP, THC
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918001020·INSTANT-VIEW Multi-Drugs of Abuse Urine Test AM...
PERICSCOPE, MODEL # PERISC1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
FDA 510(k)
FDA Class 2
·Cardiovascular
ACQSIM CT SCANNER
FDA Adverse Event
Malfunction
·PHILIPS·Product code JAK·August 12, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·April 3, 2013
BAKRI TAMPONADE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK UROLOGICAL INC·Product code KNA·February 9, 2011
MBT CEM TIBIAL TRAY SZ2.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·April 23, 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
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