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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

iBond Universal & iBond Ceramic Primer

FDA 510(k)
FDA Class 2 ·Dental

CONSENSUS CS2 PLUS ACETABULAR INSERT

FDA 510(k)
FDA Class 2 ·Orthopedic

FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300

FDA 510(k)
FDA Class 2 ·Ophthalmic

VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

FDA Adverse Event
Injury ·COOK VASCULAR INC·Product code LJT·January 7, 2016

RESERVOIR 1.8ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 6, 2013

6800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 3, 2008

VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

FDA Adverse Event
Malfunction ·COOK VASCULAR INC·Product code LJT·January 3, 2019

VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT

FDA Adverse Event
Malfunction ·COOK VASCULAR INC·Product code LJT·January 3, 2019

MREYE EMBOLIZATION COIL

FDA Adverse Event
Injury ·COOK INC·Product code KRD·May 11, 2018

MREYE EMBOLIZATION COIL

FDA Adverse Event
Injury ·COOK INC·Product code KRD·May 11, 2018

MREYE EMBOLIZATION COIL

FDA Adverse Event
Injury ·COOK INC·Product code KRD·May 11, 2018

NESTER PLATINUM EMBOLIZATION MICROCOIL

FDA Adverse Event
Injury ·COOK INC·Product code KRD·May 11, 2018

MREYE EMBOLIZATION COIL

FDA Adverse Event
Injury ·COOK INC·Product code KRD·May 11, 2018

MREYE EMBOLIZATION COIL

FDA Adverse Event
Injury ·COOK INC·Product code KRD·May 11, 2018

STAINLESS STEEL EMBOLIZATION COIL

FDA Adverse Event
Malfunction ·COOK INC·Product code KRD·August 24, 2017

VITAL-PORT

FDA Adverse Event
Injury ·COOK VASCULAR INC·Product code LJT·May 24, 2016

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018