14 results
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31ms
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Sources: EU EUDAMED, US FDA
PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033165·Baltic Denture System BDLoad BDLoad ↓ Sm6 PLSEu...
SlimLine®
FDA UDI
ZIMMER SPINE, INC.·00889024404052·
BD VACUTAINER LH PST II PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·June 23, 2021
USA SERIES LAPAROSCOPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
THERMATREK IRIS-IV INFRARED IMAGING SYSTEM
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM
FDA Adverse Event
Other
·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 1, 2013
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·March 30, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 23, 2008
BLUNT TIP SCREW, 4X34MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 6, 2023
BLUNT TIP SCREW, 4X40MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 6, 2023
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