24 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VKS/TC-PLUS REVISION KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526785526·M4S COMFORT COMPACT BLACK LEFT XL
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032215·Baltic Denture System BDLoad ↓ Mn6 PLSEum2DFm B...
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00840967187631·Battalion, LLIF Trial, 15°, 22 mm Wide, 15 mm X...
QUIK-CHECK HOME PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
FDA 510(k)
FDA Class 2
·Immunology
SCP PANEL CENTRIFUGE JMS
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DWA·November 5, 2013
S4 IMPLANTS
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code KWP·August 29, 2008
SCP PANEL CENTRIFUGE JMS
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DWA·March 14, 2014
SCP CONTROL PANEL
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·January 5, 2012
GII ARTICULAR INSERTER/EXTRACT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018
CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND·Product code DWA·January 19, 2018
CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
FDA Adverse Event
Malfunction
·LIVANOVA DEUTSCHLAND GMBH·Product code DWA·January 5, 2022
STOCKERT JMS CENTRIFUGAL PUMP SYSTEM
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·January 5, 2012
NEXGEN CR-FLEX FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·March 29, 2013
ANALYTICAL E MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code DHA·March 29, 2011
DATALINK 2000
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JQP·April 21, 2008
STOCKERT CENTRIFUGAL PUMP (SCP) SYSTEM
FDA Adverse Event
Injury
·SORIN GROUP DEUTSCHLAND·Product code DWA·May 7, 2010
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020