320 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TDM PLUS
FDA UDI
UTAK LABORATORIES, INC.·B800TDMSNKI0·TDM PLUS
CLOZAPINE PLUS
FDA UDI
UTAK LABORATORIES, INC.·B800CLOZSNKI0·CLOZAPINE PLUS
BENZODIAZEPINES 1000 NG/ML
FDA UDI
UTAK LABORATORIES, INC.·B800BENZO1000UNKI0·BENZODIAZEPINES 1000 NG/ML
ULTRA CONG INS RT SZA/13MM NK
FDA Adverse Event
Injury
·SULZER ORTHOPEDICS INC.·Product code JWH·August 15, 2000
CD63 (NKI/C3) Mouse Monoclonal Antibody
FDA UDI
CELL MARQUE CORPORATION·00841683131519·
CD63 (NKI/C3) Mouse Monoclonal Antibody
FDA UDI
CELL MARQUE CORPORATION·00841683131502·
CD63 (NKI/C3) Mouse Monoclonal Antibody
FDA UDI
CELL MARQUE CORPORATION·00841683131533·
CD63 (NKI/C3) Mouse Monoclonal Antibody
FDA UDI
CELL MARQUE CORPORATION·00841683100775·
CD63 (NKI/C3) Mouse Monoclonal Antibody
FDA UDI
CELL MARQUE CORPORATION·00841683131540·
CD63 (NKI/C3) Mouse Monoclonal Antibody
FDA UDI
CELL MARQUE CORPORATION·00841683131526·
NANOKNIFE SYSTEM
FDA Adverse Event
Death
·ANGIODYNAMICS·Product code OAB·July 15, 2024
UNKNOWN NKI KNEE COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·November 22, 2016
UNKNOWN NK I INLAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·July 12, 2019
NATURAL-KNEE SYSTEM CONGRUENT TIBIAL INSERT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·September 20, 2011
Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.
FDA Recall
Terminated
·Neuro Kinetics, Inc.·Product code GWN·July 21, 2015
SPECIAL NKI POROUS TI FEMUR SIZE 2, LEFT
FDA Adverse Event
Injury
·SULZER ORTHOPEDICS, INC.·Product code HSA·March 29, 2002
PROVOX VEGA PUNCTURE SET
FDA Adverse Event
Injury
·ATOS MEDICAL AB·Product code EWL·December 3, 2024
Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.
FDA Enforcement
Class II
·Terminated·Neuro Kinetics, Inc.·September 9, 2015
Blade, Keratome, Reprocessed
FDA classification
FDA Class 1
·Blade, Keratome, Reprocessed
Goniometer With Electrodes
FDA classification
FDA Class 2
·Goniometer With Electrodes