17 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Lumipulse G CA15-3
FDA 510(k)
FDA Class 2
·Immunology
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780419426·Integra® Miltex® House Incudostapedial Joint Kn...
FUTURA
FDA 510(k)
FDA Class 2
·Physical Medicine
HAIRMAX LASERCOMB
FDA 510(k)
FDA Class 2
·Physical Medicine
ANKLE ARTHRODESIS NAIL, LEFT 10X150MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 22, 2014
MAXPLUS EXTENSION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP·Product code FPA·June 3, 2013
MARTEL PRINTER FOR THE I-STAT 1 ANALYZER
FDA Adverse Event
Malfunction
·MARTEL INSTRUMENTS·Product code JJE·June 30, 2011
VANGUARD ROCC POR FEM S60 L
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·February 3, 2026
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·April 25, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·January 4, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Injury
·COOK INC·Product code FGE·February 18, 2019
ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·July 26, 2019
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
VANGUARD MONO FINNED STM TIB 71X8
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·August 9, 2023
VANGUARD ROCC POR FEM S60 L
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code JWH·February 20, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025