21 results
·
33ms
·
Sources: EU EUDAMED, US FDA
M3 MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
OsteoMed
FDA UDI
OSTEOMED LLC·00845694044158·1.9mm x 8mm Midface Safety Screw
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450655504·
MICASEPT DEBAKEY PERIPHERAL CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896008311·MICASEPT DEBAKEY PERIPHERAL CLAMP WITH HEGAR RA...
MICASEPT DEBAKEY PERIPHERAL ATRAUMATIC VASCULAR CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09920919080740·MICASEPT DEBAKEY PERIPHERAL ATRAUMATIC VASCULAR...
MICASEPT DEBAKEY GALEN LOBE CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896008328·MICASEPT DEBAKEY GALEN LOBE CLAMP WITH HEGAR RA...
MICASEPT DEBAKEY GALEN LOBE CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09920919080640·MICASEPT DEBAKEY GALEN LOBE CLAMP WITH HEGAR RA...
MICASEPT DEBAKEY GALEN LOBE CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09920919080040·MICASEPT DEBAKEY GALEN LOBE CLAMP WITH HEGAR RA...
MICASEPT DEBAKEY PERIPHERAL ATRAUMATIC VASCULAR CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09920919080140·MICASEPT DEBAKEY PERIPHERAL ATRAUMATIC VASCULAR...
MICASEPT DEBAKEY PERIPHERAL ATRAUMATIC VASCULAR CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896008335·MICASEPT DEBAKEY PERIPHERAL ATRAUMATIC VASCULAR...
MICASEPT DEBAKEY PERIPHERAL ATRAUMATIC VASCULAR CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896008298·MICASEPT DEBAKEY PERIPHERAL ATRAUMATIC VASCULAR...
MICASEPT DEBAKEY GALEN LOBE CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09920919080340·MICASEPT DEBAKEY GALEN LOBE CLAMP WITH HEGAR RA...
MICASEPT DEBAKEY GALEN LOBE CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896008281·MICASEPT DEBAKEY GALEN LOBE CLAMP WITH HEGAR RA...
MICASEPT DEBAKEY GALEN LOBE CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896008304·MICASEPT DEBAKEY GALEN LOBE CLAMP WITH HEGAR RA...
KONTUR 55 SOFT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
OPTIBOND SOLO PLUS 3
FDA 510(k)
FDA Class 2
·Dental
PASSPORT 2 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code CAW·September 16, 2014
BLOODLINE FOR HEMODIALYSIS
FDA Adverse Event
Malfunction
·NIKKISO MEDICAL SYSTEMS GMBH·Product code FJK·May 18, 2011
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012