17 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0310040·Probe, 1.5 inch Ball, Lenke, Straight, Black
SYVA EMIT II PLUS AMPHETAMINES ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
K2™ Hemi Toe Implant System
FDA UDI
INTEGRA LIFESCIENCES CORPORATION·10381780279471·K2™ Hemi Toe Implant System TOE PLATE
ACRY FORM
FDA UDI
DENTAL MANUFACTURING SPA·08056865003146·
NA
FDA UDI
Stryker GmbH·00886385006635·Hex Driver 2.5mm
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NEEDLELOK HYPODERMIC NEEDLE PROTECTION
FDA 510(k)
FDA Class 2
·General Hospital
*
FDA Adverse Event
Other
·*·Product code LPN·May 25, 2001
BCS(R) XP
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code GKP·April 21, 2015
CS300
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·March 28, 2013
FLOCARE INFINITY - WESTERN EUROPE
FDA Adverse Event
Injury
·MOOG MEDICAL DEVICES GROUP·Product code LZH·March 16, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008
SoftClamp II arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoClamp-ST II aortic catheter. SoftClamp II arterial cannula, 24Fr. SCK (06724). Cannulas are also packaged in kits with no specific lot numbers associated. The kits is identified as SoftClamp System, Product Code SC-24.
FDA Recall
Terminated
·Heartport Inc Route·Product code DWF·October 2, 2003
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
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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016