13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERSALAB APM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132110·Trial, TLIF, 27L OB CRV 7Deg, 11mm
LACTOSORB RAPIDFLAP
FDA 510(k)
FDA Class 2
·Dental
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP
FDA 510(k)
FDA Class 3
·Cardiovascular
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 20, 2013
INJECTOR, OPTIVANTAGE DH W/RFID
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM CO.·Product code IZQ·March 8, 2011
AFFINITY BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code HDD·March 14, 2008
RUBY COIL LP
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·June 15, 2021
PERSONA BEARING COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 28, 2019
PERSONA FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 28, 2019
PALACOS BONE CEMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 28, 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
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025