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

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DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033329·Baltic Denture System BDLoad BDLoad ↓ Mw6 PLSEu...

FASTPACK FREE T4 IMMUNOASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217

FDA 510(k)
FDA Class 2 ·Hematology

D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·February 27, 2014

D903 DIDECO AVANT 2 VAVD PHISIO

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·February 19, 2014

IT PADOVA

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·August 8, 2013

D903 DIDECO AVANT VAVD PHISIO

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DTZ·August 16, 2013

AUTOSONIX HOOK PROBE SHORT

FDA Adverse Event
Malfunction ·COVIDIEN LP, FORMERLY US SURGICAL·Product code LFL·March 1, 2013

ACCU-CHEK ® MULTICLIX

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·March 30, 2011

6.0MM TI PANGEA POLYAXIAL

FDA Adverse Event
Injury ·SYNTHES BRANDYWINE·Product code KWP·April 23, 2008

C20441 IL HAIFA

FDA Adverse Event
Other ·SORIN GROUP ITALIA·Product code DWF·March 28, 2012

ALINITY I HAVAB IGM REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT GMBH·Product code LOL·March 26, 2026

Brilliance 64 Computed Tomography X-Ray System, 510(k) #K033326, Model Number: 728231, Serial Numbers: 9745, 90169, and 95414. The recalled device systems are equipped with Version 3.5 Beta 1 software.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 22, 2011

Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, and 300005. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 29, 2011

Brilliance 64 CT (Computed Tomography) System, 510 (k) #K033326, Model #728231, Serial Numbers: 4003, 9875, and 90135. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 29, 2011

Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021. Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·November 11, 2011

Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 6, 2011

Ingenuity CT computed Tomography System, Model #728326, 510(k) #K 033326, Serial Numbers: 300010 and 300018. The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 6, 2011

Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, 300005, and 300010. Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-asectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·December 8, 2011