12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033479·Baltic Denture System BDLoad BDLoad ↓ Sw6 PLSEu...
PS CONSTRAINED INSERT XLG
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code JWH·July 20, 2017
COMPLETE BRAND MULTI-PURPOSE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
U-SYSTEMS ULTRASOUND SYSTEM USI-2000
FDA 510(k)
FDA Class 2
·Radiology
CRYOSURGICAL, ACCESSORIES
FDA Adverse Event
Injury
·GALIL MEDICAL LTD.·Product code GEH·May 11, 2021
UNKNOWN IMPLANTABLE CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·April 3, 2013
UNKNOWN ZIMMER KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·March 24, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIAYLZATOREN GMBH·Product code MSF·April 23, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
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