23 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELLEX 2RT
FDA 510(k)
FDA Class 2
·Ophthalmic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814657·GENUMEDI SILVER SIZE II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813827·GENUMEDI PRO SILVER SIZE II
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989053258·PEERLESS 2NDMOL 6DEG UR/LL NDX OTX018
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383505901·Gutta Percha Points is used to root canal filin...
NA
FDA UDI
aap Implantate AG·04042409088780·APS Lag Screw, self-tapping, TL 22, L 110
EON CHOLESTEROL REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GS 3000
FDA 510(k)
FDA Class 2
·Physical Medicine
NA
FDA UDI
aap Implantate AG·04042409088797·APS Lag Screw, self-tapping, TL 22, L 110
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 9, 2017
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 16, 2019
UNKNOWN NEXGEN KNEE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·May 17, 2013
DPM 6 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY BIOMEDICAL ELECTRONICS CO. LTD·Product code MHX·September 18, 2014
OUTBACK RE-ENTRY CATHETER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code DQY·June 13, 2011
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 17 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 26, 2021
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 15, 2022
GMK-PRIMARY TIBIAL INSERT UC FIXED 3 / 17 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 27, 2016
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 30, 2016
GMK PS TIBIAL INSERT SIZE 3 / 17 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·June 11, 2015
The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.
FDA Enforcement
Class II
·Ongoing·Ithera Medical Gmbh·February 19, 2025