20 results
·
26ms
·
Sources: EU EUDAMED, US FDA
FORMALIN BUFFER CONCENTRATE
FDA 510(k)
FDA Class 1
·Pathology
NA
FDA UDI
KEY SURGICAL, INC.·10849771049316·K-Wires, Double diamond, .035-inch (.9mm) diame...
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771012696·K-Wires, Double diamond, .035-inch (.9mm) diame...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292930·
Alinity m Integrated Reaction Units (IRU)
FDA Enforcement
Class II
·Terminated·Abbott Molecular, Inc.·March 9, 2022
NON-BR2000 LARGE BONE BLADES
FDA UDI
Peter Brasseler Holdings, LLC·00887919095248·KM71-201
K-Wire w. double end lanzet point 0.89mm/102mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM712010·K-Wire w. double end lanzet point
0.89mm...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189930·Tibial Tray Drill Bushing Assembly
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484481·K-Wire w. double end lanzet point _x000D_...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77712011·Micro Sprint Bracket McLaugh/Benn/Trev. .022" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77712011001·Micro Sprint Bracket McLaugh/Benn/Trev. .022" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77712010051·Micro Sprint Bracket McLaugh/Benn/Trev. .022" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77712010101·Micro Sprint Bracket McLaugh/Benn/Trev. .022" m...
ZEO CE LIGHT & ZEO QUICK PORCELAIN
FDA 510(k)
FDA Class 2
·Dental
NeuViz Prime Multi-slice CT Scanner System
FDA 510(k)
FDA Class 2
·Radiology
Alinity m Integrated Reaction Units (IRU)
FDA Recall
Terminated
·Abbott Molecular, Inc.·Product code OOI·February 11, 2022
RENASYS SOFT PORT STAND ALONE
FDA Adverse Event
Malfunction
·SMITH & NEPHEW WOUND MANAGEMENT·Product code BTA·April 24, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 3, 2012
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 27, 2010
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020