11 results
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18ms
·
Sources: EU EUDAMED, US FDA
CAVITRON ULTRASONIC SURG. ASPIR. CUSA
FDA 510(k)
FDA Unclassified
·Unknown
ACUMED
FDA UDI
Acumed LLC·10806378050411·Polarus® 3 4.3mm Screw Tap
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580162300001·SURE-SNAP 1. MOLAR UPR RGT SZ 23
SCULPTURE FLOW
FDA 510(k)
FDA Class 2
·Dental
SYNTHES RIB FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2014
TOTAL ASR FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·October 23, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 25, 2007
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025