15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FIJI SUN FLUORESCENT TANNING UNIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100219·LIEBERMAN ASPIRATING SPECULUM K-WIRE
MaxFuse,VBR, 12 (D) x 14 (W) x 16 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055950·12 (D) x 14 (W) x 16 (H)
WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
FDA 510(k)
FDA Class 2
·Anesthesiology
GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 13, 2025
IDENTITY XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC, CRMD·Product code DXY·January 13, 2014
TRANSVENOUS
FDA Adverse Event
Malfunction
·GUIDANT PUERTO RICO BV·Product code NVN·July 6, 2011
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 7, 2013
AMISTEM H, HA COATED STEM SIZE 4 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 2, 2017
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 22, 2016
VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·March 2, 2018
AERO LL FIXATION ANCHOR, 50MM
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code OVD·March 25, 2019
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016