13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
FDA 510(k)
FDA Class 2
·Cardiovascular
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583024332·CH60 ITED, L BE CHARM 60
ANKLE ARTHRODESIS NAIL, LEFT 10X150MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2010
RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3
FDA 510(k)
FDA Class 2
·Radiology
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TBD
FDA Adverse Event
Malfunction
·Product code KOD·April 5, 2018
CORTSCR Ø2.7 SELF-TAP L22 SST
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·November 20, 2019
UNKNOWN DEPUY PINNACLE METAL LINER
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ? REG. # 8010379·Product code KWA·May 29, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 17, 2011
MARLEX MESH
FDA Adverse Event
Injury
·Product code FTL·August 22, 2008
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
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
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015