32 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C
FDA 510(k)
FDA Class 2
·Hematology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813148·GENUMEDI PRO SILVER SIZE I
ArgenZ HT+ 98x25 C1
FDA UDI
ARGEN CORPORATION, THE·D818122101·Dental porcelain/ceramic restoration kit
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989053128·PEERLESS 2NDMOL 6DEG UR/LL WDX 0TX022
CASCADIA Interbody System
FDA UDI
VB Spine LLC·10888857551800·Inserter Outer Shaft
MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR
FDA 510(k)
FDA Class 1
·General Hospital
SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA
FDA 510(k)
FDA Class 1
·Neurology
ZENIX
FDA UDI
Zoll Medical Corporation·00198843000056·ZENIX, EMS STANDARD CONFIGURATION
GMK STANDARD CEMENTED FEMUR SIZE 5 LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code JWH·December 19, 2013
POWERCROSS? .018" OTW PTA DILATATION CATHETER
FDA Adverse Event
Injury
·EV3 INC.·Product code DQY·May 21, 2013
SPECTRANETICS GLIDELIGHT LASER SHEATH
FDA Adverse Event
Injury
·SPECTRANETICS CORPORATION·Product code MFA·September 26, 2014
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 13, 2011
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·May 25, 2004
UNK - CONSTRUCTS: LCP CLAVICLE PLATE/SCREWS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·December 29, 2022
UNK - CONSTRUCTS: LCP CLAVICLE PLATE/SCREWS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·December 29, 2022
UNK - CONSTRUCTS: LCP CLAVICLE PLATE/SCREWS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·December 29, 2022
PERCEPT
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·October 17, 2025
UNK - CONSTRUCTS: LCP CLAVICLE PLATE/SCREWS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·December 29, 2022
ALINITY C PROCESSING MODULE
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code JJE·January 15, 2021
SOMATOM Edge Plus-Computed tomography system Model 1026700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022