17 results · 20ms · Sources: EU EUDAMED, US FDA

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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