12 results · 28ms · 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.

NASAL JACKS MASK

FDA 510(k)
FDA Class 2 ·Anesthesiology

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032433·Baltic Denture System BDLoad ↓ Sm6 PLSEum6DFs B...

NEOGENESYS 2K

FDA 510(k)
FDA Class 2 ·Neurology

VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896

FDA 510(k)
FDA Class 2 ·Immunology

SMART MONITOR 2 PS

FDA Adverse Event
Malfunction ·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014

6F ANGIO-SEAL STS PLUS

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, PUERTO RICO·Product code MGB·March 29, 2013

ACRYSOF

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·March 25, 2011

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FNL·April 16, 2008

SMART MONITOR 2 PS

FDA Adverse Event
Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013

AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

FDA Enforcement
Class II ·Terminated·Unomedical As·November 9, 2016

The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

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