13 results
·
33ms
·
Sources: EU EUDAMED, US FDA
ALASTIK
FDA 510(k)
FDA Class 1
·Dental
VARIAX
FDA UDI
Stryker GmbH·07613327126037·Insert - Reduction Instruments 1, F&A
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981195502·Interbody, 9mm x 40mm x 16mm, 15 deg
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981203498·Interbody, 9mm x 40mm x 16mm, 15 deg
Excipio SV
FDA UDI
Contego Medical, Inc.·00851616007491·The Excipio SV Thrombectomy Device is indicated...
MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE
FDA 510(k)
FDA Class 2
·Cardiovascular
REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805
FDA 510(k)
FDA Class 2
·Cardiovascular
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·December 23, 2010
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·March 21, 2014
PKG, BIOPSY FORCEPS, PUNCH, P/N 0250080290. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026