17 results
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20ms
·
Sources: EU EUDAMED, US FDA
UltraScore Focused Force PTA Balloon
FDA 510(k)
FDA Class 2
·Cardiovascular
Humelock II Cemented Shoulder System
FDA UDI
FX SOLUTIONS·03701037304778·HUMELOCK II TRIAL STEM T12
STAR™
FDA UDI
Stryker GmbH·00886385016856·PE TRIAL CADDY ASSEMBLY
LEONE SPA
FDA UDI
LEONE SPA·08033707023364·CALIBRA BANDS 2ND MOLAR n.SLR 12
STAR™
FDA UDI
Stryker GmbH·00886385016863·CADDY BASE, PE TRIAL CADDY
STAR™
FDA UDI
Stryker GmbH·00886385016870·LID, PE TRIAL CADDY
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837016494·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0600120·Tray Insert 5, Cosmolock Deformity
OCTRODE TRIAL LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·January 6, 2015
O-pel Laser and families of probe delivery devices
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLIRPATH TURBO PERIPHERAL CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
12" (30 CM) APPX 0.60ML SMALLBORE EXT SET W/ 0.22 MICRON AIR ELIMINATING FILTER,
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·July 30, 2020
SIG MOD TIB TRAY CEM COCR 3
FDA Adverse Event
Injury
·DEPUY RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·December 9, 2008
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 31, 2011
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 1, 2013
INTELLIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 24, 2018
Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 12, 2018