20 results · 38ms · Sources: EU EUDAMED, US FDA

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OPTI PADS

FDA 510(k)
FDA Class 2 ·Ophthalmic

Medtronic Reusable Instruments

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978084060·INSTRUMENT 950-940 ANTR IVD 4MM 10MM CP

PMP4 MEDICAL WEB CENTER

FDA 510(k)
FDA Class 2 ·Cardiovascular

Atmo Gas Capsule System

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

S3 ROLLER PUMP

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR)·Product code DTQ·April 23, 2010

3 TO 1 REDUCTION DRIVE

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·December 14, 2011

S3 ROLLER PUMP MODULE AND CONSOLE

FDA Adverse Event
Malfunction ·SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR·Product code DTQ·March 24, 2010

3-TO-1 REDUCTION DRIVE

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHMAND·Product code DTQ·December 14, 2011

STOCKERT S3 CONSOLE

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·October 6, 2011

STOCKERT S3 CONSOLE

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·October 6, 2011

UNIPLEX NANOLINE CANNULA

FDA Adverse Event
Malfunction ·PAJUNK GMBH MEDIZINTECHNOLOGIE·Product code BSP·December 22, 2010

OMNIFIT M/S PSL SHELL 56MM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·February 8, 2013

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Injury ·TANDEM DIABETES CARE INC.·Product code LZG·July 14, 2014

LIGACLIP ROTATING MULTIPLE CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GDO·October 4, 1996

SENSOR, LOW LEVEL II

FDA Adverse Event
Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·April 16, 2010

S3 ROLLER PUMP

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND (SORIN GROUP USA, INC. IS DISTRIBUTOR)·Product code DTQ·April 23, 2010

S3 ROLLER PUMP

FDA Adverse Event
Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·April 22, 2010

S3 ROLLER PUMP

FDA Adverse Event
SORIN GROUP DEUTSCHLAND·Product code DWB·October 12, 2016

BLOOD CARDIOPLEGIA INSERTS

FDA Adverse Event
Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·March 24, 2010

Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024