19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARRW EVOLUTION
FDA 510(k)
FDA Class 2
·General Hospital
n/a
FDA UDI
HANS RUDOLPH, INC.·00874750006878·3850B 2 PNT HTR CTRL 115V 60HZ
TRABECULAR METAL TIBIAL CONE AUGMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TARGETING ARM PROX. LAT. TIBIA LEFT
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·February 2, 2012
DUO-VENT CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 29, 2022
BD SYRINGE 1ML LS 25G 5/8IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·May 13, 2024
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·October 31, 2022
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 1, 2022
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·October 3, 2016
ASKU
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 26, 2025
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·March 16, 2020
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·March 16, 2020
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 17, 2014
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·May 25, 2011
CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·September 14, 2020
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025