31 results · 24ms · Sources: EU EUDAMED, US FDA

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VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

TRILLIANT SURGICAL SUBTALAR IMPLANT

FDA 510(k)
FDA Class 2 ·Orthopedic

AKLARUS PHOTOTHERAPY SYSTEM

FDA 510(k)
FDA Class 2 ·Physical Medicine

T:SLIM X2 INSULIN PUMP

FDA Adverse Event
Injury ·TANDEM DIABETES CARE·Product code OYC·September 18, 2019

1823260-2015-04249

FDA Adverse Event
Malfunction ·September 30, 2015

1823260-2015-03867

FDA Adverse Event
Malfunction ·July 27, 2015

ANALYTICAL E MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 30, 2015

1823260-2015-06132

FDA Adverse Event
Malfunction ·December 28, 2015

1823260-2015-03937

FDA Adverse Event
Malfunction ·August 12, 2015

COBAS E411 RACK SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 26, 2015

1823260-2015-03563

FDA Adverse Event
Malfunction ·June 1, 2015

ARCHITECT CA 15-3

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code MOI·October 3, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

SCRDRIVERSHAFT T25 F/URS

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HXX·June 21, 2013

FUJIFILM DOUBLE BALLOON ENDOSCOPES EN-450T5/W

FDA Adverse Event
Death ·FUJIFILM CORPORATION·Product code FDA·January 26, 2024

1823260-2015-03804

FDA Adverse Event
Malfunction ·July 15, 2015

COBAS 8000 E602 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 10, 2015

1823260-2015-03580

FDA Adverse Event
Malfunction ·June 4, 2015

1823260-2015-03666

FDA Adverse Event
Malfunction ·June 17, 2015

1823260-2015-04332

FDA Adverse Event
Malfunction ·October 14, 2015