16 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

VAX-D GENESIS G2 SYSTEM

FDA 510(k)
FDA Class 2 ·Physical Medicine

EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MERIDIAN-II AND MERDIAN-PLUS

FDA 510(k)
FDA Class 2 ·Neurology

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Injury ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 18, 2018

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 13, 2020

ANGIOGUARD EMBOLI CAPTURE GUIDEWIRE SYSTEM

FDA Adverse Event
Injury ·CORDIS CORPORATION·Product code NTE·April 22, 2013

HARMONIC ACE SHEARS 5.5 DIAM.

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, INC.·Product code LFL·April 21, 2011

ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·July 8, 2008

PATIENT SAFETY NET

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code MSX·March 31, 2016

PATIENT SAFETY NET

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code MSX·March 31, 2016

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Death ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

FDA Adverse Event
Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 26, 2018

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

Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018