20 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·October 23, 2019
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018
METAFLEXCOIL
FDA 510(k)
FDA Class 2
·Radiology
GLOBUS PREMIUM MUSCLE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 11, 2013
ARCHITECT ANTI-HCV
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code MZO·July 14, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2014
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·May 6, 2021
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 7, 2025
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2020
PROWLER SELECT PLUS 150/5CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRA·May 30, 2023
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2020
EU 4.5X37MM STENT 12 MM DW TIP
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·March 7, 2023
LZOVERSAFITCUP CC TRIO NO HOLE CUP
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 3, 2019
MPACT ACETABULAR SHELL Ø52 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·August 29, 2018
BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·April 11, 2019
EU 4.5X37MM STENT 12 MM DW TIP
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·December 6, 2022
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018