12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves
FDA 510(k)
FDA Class 1
·General Hospital
ambIT*
FDA UDI
Avanos Medical, Inc.·00193494001063·ambIT* Chemotherapy Kit
ambIT
FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00857595005893·ambIT Chemotherapy Kit
ELMED
FDA UDI
ELMED INCORPORATED·00842180120891·5 MM DIA., 32 CM CLASSIC BIPOLAR LAPAROSCOPIC F...
Hive Stand-alone Anterior Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
AGILITY ANKLE REVISION PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
ATTUNE FB TIB BASE SZ 5 CEM
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code JWH·December 19, 2025
BARRIGEL INJECTABLE GEL
FDA Adverse Event
Malfunction
·PALETTE LIFE SCIENCES·Product code OVB·June 24, 2024
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 3, 2014
SYBRONPRO XRT
FDA Adverse Event
Injury
·EBI INC.·Product code DZE·August 23, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021