16 results
·
18ms
·
Sources: EU EUDAMED, US FDA
GUIDEWIRE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111000·INSTRUMENT CADDY SMALL
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756097291·FULL LENGTH KODEL
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668111017·SILICONE MAT FOR INSTRUMENT CADDY
Pinnacle
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730010810·Pinnacle .022 R UR2 +8T 9A 0O (10PK)
Pinnacle®
FDA UDI
Ortho Organizers, Inc.·00190707112752·Pinnacle .022 R UR2 +8T 9A 0O (10PK) PINNACLE
Votion®
FDA UDI
Ortho Organizers, Inc.·00190707114688·Votion .022 R UR2 +8T 9A 0O (10PK) VOTION
Votion
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730008985·Votion .022 R UR2 +8T 9A 0O (10PK)
Steri-Shield
FDA UDI
STRYKER CORPORATION·07613327625462·8 Tie Back Toga with Anti-Reflective Face Shield
FLIGHTPLAN FOR LIVER
FDA 510(k)
FDA Class 2
·Radiology
COMPAS
FDA 510(k)
FDA Class 2
·Anesthesiology
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·January 17, 2013
7900
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·December 9, 2010
11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·July 9, 2014
SOFT-VU HALO
FDA Adverse Event
Malfunction
·ANGIODYNAMICS, INC.·Product code DQO·November 16, 2007
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015