13 results · 22ms · Sources: EU EUDAMED, 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