22 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469
FDA 510(k)
FDA Class 2
·General Hospital
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032789·Baltic Denture System BDLoad ↓ Mw7 PLSEum2DFm A...
MEDEVIEW SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·January 12, 2012
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWQ·October 30, 2009
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 3, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code KWP·July 29, 2011
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·September 11, 2018
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 17, 2020
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 13, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·October 11, 2019
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 10, 2019
GREENLIGHT MOXY FIBER OPTIC
FDA Adverse Event
Malfunction
·AMS INNOVATIVE CENTER-SAN JOSE·Product code GEX·March 29, 2013
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 29, 2011
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·April 23, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·June 30, 2021
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 7, 2020