20 results · 36ms · Sources: EU EUDAMED, US FDA

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Z6 Diagnostic Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

Oticon

FDA UDI
Oticon A/S·05707131334633·OPN 2, KIT 312 NFM 85 R C001

SA FLOWABLE ADHESIVE

FDA 510(k)
FDA Class 2 ·Dental

TRIMIRA OCS 3000

FDA 510(k)
FDA Class 2 ·Dental

1823260-2015-04327

FDA Adverse Event
Malfunction ·October 14, 2015

1823260-2015-03801

FDA Adverse Event
Malfunction ·July 14, 2015

1823260-2015-03952

FDA Adverse Event
Malfunction ·August 12, 2015

DLT TS CER HD 12/14 40MM +1.5

FDA Adverse Event
Injury ·DEPUY IRELAND 9616671·Product code LZO·June 30, 2014

TRI-LOCK BPS SZ 9 STD OFFSET

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·June 30, 2014

LIGACLIP** ENDOSCOPIC CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 21, 2013

REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code LXH·July 5, 2011

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

ALTRX +4 10D 40IDX58OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 30, 2014

1823260-2015-04111

FDA Adverse Event
Malfunction ·September 9, 2015

1823260-2015-03576

FDA Adverse Event
Malfunction ·June 2, 2015

1823260-2015-03948

FDA Adverse Event
Malfunction ·August 12, 2015

1823260-2016-00393

FDA Adverse Event
Malfunction ·March 31, 2016

1823260-2015-04450

FDA Adverse Event
Malfunction ·November 5, 2015

1823260-2015-03781

FDA Adverse Event
Malfunction ·July 10, 2015

1823260-2017-01826

FDA Adverse Event
Malfunction ·August 28, 2017