16 results
·
22ms
·
Sources: EU EUDAMED, US FDA
LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VARIAX
FDA UDI
Stryker GmbH·07613327123425·Insert, Distal Radius Frag. Spec. Plates & Ins
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756554916·LAVH TRAY PGYBK
NEXUS MIDLINE CT CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GYNECARE TVT W/PRLNE BLUE MESH 1 EACH
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code OTN·October 12, 2022
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·June 19, 2014
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code CAW·February 2, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·December 29, 2010
ASPHERE M SPEC 12/14 40 +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 18, 2013
PINNACLE MTL INS NEUT40IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 18, 2013
PINNACLE MTL INS NEUT40IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·December 13, 2012
ASPHERE M SPEC 12/14 40 +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·December 13, 2012
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·September 8, 2025
BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020