14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Giraffe Incubator Carestation CS1
FDA 510(k)
FDA Class 2
·General Hospital
LACTOSORB SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036055868·
BLUE MOUNTAIN CERVICAL PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
SAUFLON FLAT COLOURED LENS CASE
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 8, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
ATTAIN OTW
FDA Adverse Event
Injury
·MPRI·Product code LWP·June 8, 2013
INSTINCT ENDOSCOPIC HEMOCLIP
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code PKL·July 19, 2021
INSTINCT ENDOSCOPIC HEMOCLIP
FDA Adverse Event
Injury
·WILSON-COOK MEDICAL INC·Product code PKL·September 12, 2022
4.5MM TI CORTEX SCREW SELF-TAPPING 85MM
FDA Adverse Event
Injury
·SYNTHES GRENCHEN·Product code HWC·April 23, 2015
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 13, 2026
Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·May 16, 2018
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023