27 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Parcus Synd-EZ SS
FDA 510(k)
FDA Class 2
·Orthopedic
Costco
FDA UDI
Bernafon AG·05711584088166·CAPTO 1 B 105, 2.4G NFM DPB SABE/MSIL DEMO COSTC
EU-TTG IGA AND EU-TTG IGG
FDA 510(k)
FDA Class 2
·Immunology
COOLTOUCH VARIA ND:YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ROSA RECON PLATFORM 220V
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·February 1, 2022
ROSA RECON PLATFORM 220V
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·February 4, 2022
ROSA RECON PLATFORM 220V
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·February 1, 2022
ROSA RECON PLATFORM 220V
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·April 4, 2022
ROSA RECON PLATFORM 220V
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·March 9, 2022
ROSA RECON PLATFORM 220V
FDA Adverse Event
Malfunction
·ZIMMER CAS·Product code OLO·March 21, 2022
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 3, 2015
BEND-IRON F/RECOPL 3.5+4.5 L190
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXP·June 27, 2013
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·October 22, 2014
UNK
FDA Adverse Event
Injury
·UNK·Product code FWM·February 20, 2008
ROSA RECON PLATFORM 220V
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code OLO·November 8, 2021
ROSA KNEE PLATFORM GB PL G
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·January 13, 2022
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
ROSA RECON PLATFORM 220V
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·January 10, 2022
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
ROSA RECON PLATFORM 220V
FDA Adverse Event
Injury
·ZIMMER CAS·Product code OLO·April 6, 2022