15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SCENIUM
FDA 510(k)
FDA Class 2
·Radiology
Ambler Value Line
FDA UDI
AMBLER SURGICAL CORP.·00190660218485·Tissue forceps, 10'', straight, 1x2 teeth, flat...
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019
FORCE FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VELA XL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·March 7, 2014
CORNERSTONE-SR TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 11, 2018
LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·August 24, 2016
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
AXXESS PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 16, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 7, 2015
CORNERSTONE-SR TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·September 7, 2017
CORNERSTONE-SR® TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 6, 2025
CORNERSTONE-SR® TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 8, 2024
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. 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.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015