13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PAPAYA & PAPAYA Plus
FDA 510(k)
FDA Class 2
·Dental
NEXT Medium Orange Vanilla Prophy Paste Box 200
FDA UDI
Preventech·D024220423·NEXT Medium Orange Vanilla Prophy Paste Box of ...
GENZYME CORPORATION
FDA registration
GENZYME CORPORATION·1 product·🇺🇸 United States
ANESTHESIA 17GAX18CM DURASAFE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code CAZ·August 20, 2021
Electric Wheelchair (XW-LY001)
FDA 510(k)
FDA Class 2
·Physical Medicine
BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SEPRAMESH IP
FDA Adverse Event
Injury
·GENZYME BIOSURGERY·Product code MCN·June 24, 2005
SYNCHROMED EL
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTURING·Product code LKK·October 31, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 23, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021