25 results
·
29ms
·
Sources: EU EUDAMED, US FDA
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
5540 1L SYRINGE
FDA UDI
HANS RUDOLPH, INC.·00817136020938·5540 1L CAL SYR 35MM ID ORING
LEYLA Retractor Socket
FDA UDI
Noras MRI products GmbH·04251269201103·
LEYLA Retractor Socket
FDA UDI
Noras MRI products GmbH·04251269205392·
External Fixation
FDA UDI
Life Spine, Inc.·00190837023737·5.5mm Rod Cutter
COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·December 7, 2022
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·October 24, 2015
VA LOCKSCR Ø2.4 SELF-TAP L12 TAN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 18, 2013
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 8, 2013
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON·Product code HET·June 3, 2011
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·August 11, 2008
Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
FDA Enforcement
Class II
·Terminated·St. Jude Medical·November 20, 2013
VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·April 27, 2022
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·July 30, 2015
SCREW,FIXATION,BONE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HWC·December 30, 2014
UNK - SCREWS: 2.7 MM VA LOCKING
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·March 1, 2024
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 22, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·August 12, 2016