20 results
·
31ms
·
Sources: EU EUDAMED, US FDA
LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
FDA 510(k)
FDA Class 2
·Hematology
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489112839·TrueForm Nitrile Exam Gloves, Medium
Cardiovascular Procedure Kit
FDA UDI
Terumo Cardiovascular Systems Corporation·00699753463318·
LEONE SPA
FDA UDI
LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue
Cardiovascular Procedure Kit
FDA UDI
Terumo Cardiovascular Systems Corporation·50699753463313·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450150429·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450465301·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450391402·
BREAST IMMOBILIZATION DEVICE MR-BY 160
FDA 510(k)
FDA Class 2
·Radiology
RANDOX PHENOBARBITAL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
A5 ANESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code BSZ·April 30, 2013
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·April 20, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·August 1, 2008
3DMAX
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·April 10, 2023
G7 OSSEOTI MULTIHOLE 74MM J
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 21, 2023
G7 SCREW 6.5MM X 25MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·August 21, 2023
Custom Kit
FDA Recall
Terminated
·Merit Medical Systems, Inc·Product code DQO·May 16, 2003
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
FDA Enforcement
Class II
·Terminated·Merit Medical Systems, Inc.·November 30, 2016
Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 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