15 results
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20ms
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Sources: EU EUDAMED, US FDA
HairCheck-DT (PCP)
FDA UDI
Quest Diagnostics·00868586000254·HairCheck-DT (PCP) is an ELISA test kit used fo...
QUEST DIAGNOSTICS HAIRCHECK-DT (PCP
FDA 510(k)
FDA Unclassified
·Unknown
NA
FDA UDI
Stryker GmbH·00886385005560·Cortical Screw, Non-Lock., Self-tap., T6 Drive
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809868142·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND CLOSED...
3-Lead Leadset,Adt/Ped,AHA,Clip
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904004488·
Unimed
FDA UDI
Unimed Medical Supplies, Inc.·06945664882637·ECG Monitor Lead wire/MR type/3-lead/grabber/AH...
TCOYF FERTILITY SOFTWARE VERSION 1.0
FDA 510(k)
FDA Unclassified
·Unknown
PROSAFE SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·February 19, 2018
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·March 31, 2016
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 2, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 27, 2014
INSIGNIA ULTRA
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008
PKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, SINGLE ACTION, P/N 0250080584 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
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