21 results
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39ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809872330·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND OPEN T...
NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY
FDA 510(k)
FDA Class 1
·Microbiology
NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HRS·January 21, 2016
RED DCI-DC3 SENSOR
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·September 15, 2015
RD SET GE - 12
FDA Adverse Event
Malfunction
·Product code DQA·August 13, 2021
MATRIXNEURO STERILE KIT STD 4
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JEY·December 19, 2013
TI MATRIXNEURO BURR HOLE COVER24MM
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JEY·October 28, 2015
RD SET DCI
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·February 17, 2017
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DTQ·April 4, 2013
VITALITY DS VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011
MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 1U I/C
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 23, 2013
MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code JEY·August 28, 2015
Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·February 5, 2014
KIT, RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·May 10, 2019
KIT, RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·May 10, 2019
KIT, RADICAL-7 HANDHELD
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·May 10, 2019
RD SET NEO CS-3
FDA Adverse Event
Malfunction
·MASIMO - 52 DISCOVERY·Product code DQA·January 29, 2021