25 results · 29ms · Sources: EU EUDAMED, US FDA

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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