18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL ENT-4L-FLEXIBLE NASOPHARYNGO-
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
VIALOK NON-VENTED
FDA 510(k)
FDA Class 2
·General Hospital
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
FDA 510(k)
FDA Class 2
·Orthopedic
AGC DA2000 KN TIB BRG 71/75X14
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·August 31, 2016
BIOMET AGC V2 INTERLOK TIBIAL 22X 67MM
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code HRY·June 16, 2017
AGC V2 INTERLOK TIB 10X 71MM
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code HRX·May 19, 2017
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·May 28, 2025
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
FDA Enforcement
Class II
·Ongoing·Philips North America·August 6, 2025
ETS LINEAR CUTTER RELOAD
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 20, 2014
ADVANTA 2 BED
FDA Adverse Event
Malfunction
·HILL-ROM DE MEXICO S DE RL DE CV·Product code FNL·October 31, 2012
SENSOR,MMT-7002C,10PK,GLUCOSE,BSA,17L
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·August 26, 2010
AGC V2 INTERLOK TIB 8 X 75MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·April 12, 2017
AGC V2 INTERLOK TIB 8 X 79MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·March 22, 2016
SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;
FDA Recall
Open, Classified
·Philips North America·Product code LNH·June 30, 2025
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·May 13, 2025
AGC REVISION KNEE TIBIAL AUGMENTATION
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·June 28, 2017
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.
FDA Recall
Open, Classified
·Philips North America·Product code LNH·April 14, 2026