15 results · 35ms · Sources: EU EUDAMED, US FDA

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PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

NEXT GENERATION SALEM SUMP

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code JEY·March 3, 2017

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 11, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 11, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·October 8, 2020

TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code DZL·September 6, 2017

HEART START XL

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 11, 2013

ADVANTA BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·March 15, 2011

CONTAK RENEWAL 3 RF

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 12, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 25, 2020

TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code JEY·March 3, 2017

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