13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
COMPASS CT, COMPASS CT PORT
FDA 510(k)
FDA Class 2
·Cardiovascular
Black Silicone
FDA UDI
COOK INCORPORATED·00827002151451·Black Silicone Filiform Dbl Pigtail Ureteral St...
Cook
FDA UDI
COOK INCORPORATED·00827002464391·Black Silicone Filiform Double Pigtail Ureteral...
WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PACS SOFTWARE SOLUTION 2003
FDA 510(k)
FDA Class 2
·Radiology
U-BLADE SET, TI GAMMA3 10.5X100MM
FDA Adverse Event
Injury
·STRYKER OSETOSYNTHESIS KIEL·Product code HSB·December 18, 2012
LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·August 24, 2016
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 29, 2013
LAMITRODE 88 SURGICAL LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 16, 2011
ITREL 3
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 20, 2008
MISCELLANEOUS
FDA Adverse Event
Injury
·COOK UROLOGICAL INC.·Product code FAD·December 4, 2008
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
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