15 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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DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI
FDA 510(k)
FDA Class 2
·Clinical Chemistry
N/A
FDA UDI
Smith & Nephew, Inc.·00885556601648·SOD CANN 9MM 60MM WORKING LG
Ophthlamic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668115541·INFANT SPECULUM 4MM SOLID (10/BX)
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746109287·DB BKT MINI MS UL CEN 022 T+17 A+4 R=0
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 3, 2024
CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC
FDA 510(k)
FDA Class 2
·General Hospital
DIACAM (510(K) K 901019)
FDA Adverse Event
Other
·SIEMENS MEDICAL SYSTEMS·Product code KPS·March 13, 2001
STRAIGHT EXACT BROACH HANDLE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LXH·December 10, 2018
ATLAS II PLUS DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 30, 2014
HEARTSTREAM FR2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 13, 2012
CLRFLXC
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·November 17, 2010
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 Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024