15 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APPRAISE URINE MICROALBUMIN COLLECTION KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IMAGINE H.E.
FDA 510(k)
FDA Class 2
·Dental
CADD MEDICATION CASSETTE
FDA Adverse Event
Malfunction
·NULL·Product code FPA·February 4, 2022
PAXGENE® BLOOD RNA TUBE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code NTW·May 1, 2026
TOTAL ASR FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·April 29, 2013
RETROX RX 45-JBP
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code DTB·April 29, 2011
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·July 25, 2008
ISODUR PROSTHESIS HEAD 12/14 32MM XL
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014
UNSPECIFIED BD PAXGENE® BLOOD TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code PJE·June 13, 2025
PAXGENE® BLOOD RNA TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·March 23, 2026
PAXGENE® BLOOD RNA TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·March 31, 2026
PAXGENE® BLOOD RNA TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·February 9, 2026
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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