19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0140120·Guide, Anti-Splay
DOC BAND
FDA 510(k)
FDA Class 2
·Neurology
Versacryl
FDA UDI
Keystone Industries·H66810140121·Acrylic HC Hardener Liquid, 60 ml
Aztec
FDA UDI
Aztecmed/Ent LLC·B87110140120·Goldman Nasal Fracture Elevator
ANODYNE Plate System
FDA UDI
CORELINK LLC·M7252014012·ANODYNE CERVICAL SCREW - VARIABLE SELF DRILLIN...
ANCA Test System
FDA UDI
IMMUNO CONCEPTS INC·M74910140121·ANCA FA Test System - Formalin Fixed Substrate ...
ANCA Test System
FDA UDI
IMMUNO CONCEPTS INC·M7491014012T1·ANCA FA Test System - Formalin Fixed Substrate ...
ESSENCE STEERABLE GUIDEWIRES
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code DQX·June 19, 2014
IMPRA CARBOFLO EPTFE VASCULAR GRAFTS
FDA 510(k)
FDA Class 2
·Cardiovascular
LC PROVIFILL
FDA 510(k)
FDA Class 2
·Dental
ELLUME COVID-19 HOME TEST
FDA Adverse Event
Malfunction
·ELLUME LIMITED·Product code QKP·December 20, 2021
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
LEGEND FOOTED ATTACHMENT
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·March 10, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 13, 2008
Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.
FDA Enforcement
Class II
·Terminated·SEPPIM SAS·November 13, 2013
WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·April 22, 2015
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 24, 2021
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
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 6, 2015