12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PEREGRINE DIFFUSION LIGHT PIPE
FDA 510(k)
FDA Class 2
·Ophthalmic
Sierra
FDA UDI
Seaspine Orthopedics Corporation·10889981095765·Connector Caddy
Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER
FDA 510(k)
FDA Class 1
·General Hospital
G7 PPS LTD ACET SHELL 56F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 31, 2019
CER OPT TYPE 1 TPR SLEVE 0MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·June 6, 2019
TPRLC 133 MP TYPE1 PPS HO 16.0
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 31, 2019
G7 NEUTRAL E1 LINER 36MM F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·May 31, 2019
DEPUY ASR XL FEM IMP SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 8, 2013
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·January 6, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 22, 2014
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024