33 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2
FDA 510(k)
FDA Class 2
·Cardiovascular
Redicare
FDA UDI
REDICARE LLC·B70901120070·1 Kit Tweezers (forceps) Non-Sterile Intended f...
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193109114·HA PEEK EVOS Straight, ,7mmx8mmx 22mm , FLAT 5 ...
AXS
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327358568·BONE SCREW, AXS, SELF-TAPPING
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540491244·BONE SCREW, CROSS-PIN, SELF-TAPPING
RHS HELMET
FDA 510(k)
FDA Class 2
·Neurology
PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,
FDA 510(k)
FDA Class 2
·Anesthesiology
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code OLO·April 25, 2014
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code NPJ·April 25, 2014
RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD PLASTIPAK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·October 10, 2022
BD PHASEAL¿ INJECTOR LUER LOCK N35
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·August 4, 2022
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 14, 2013
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code FPA·June 2, 2011
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·August 12, 2008
BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·November 26, 2018
Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5, REF 34358-268, UPN H749343582680, Sterile EO Made in Mexico Avenida Norske Edicficio G1, Local B y H Parque Industrial La Mesa, Fracc. Rubio La Mesa, Tijuana, B.C. Mexico C.P. 22550
FDA Recall
Terminated
·Boston Scientific·Product code DQY·September 11, 2007
Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78, UPN H74934358780, Sterile EO, Made in Mexico Avenida Norske Edicficio G1, Local B y H Parque Industrial La Mesa, Fracc. Rubio La Mesa, Tijuana, B.C. Mexico C.P. 22550
FDA Recall
Terminated
·Boston Scientific·Product code DQY·September 11, 2007
LADAR6000 Excimer Laser System
FDA Recall
Terminated
·Alcon Refractive Horizons, Inc.·Product code LZS·February 21, 2007
Philips Medical HeartStartXL Defibrillator/Monitor Model : M4735A
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·June 11, 2007