18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Examination gloves -Type C (Nitrile gloves)
FDA 510(k)
FDA Class 1
·General Hospital
NuVasive
FDA UDI
Nuvasive, Inc.·00195377046857·NTS Slot Tube, 22x90mm Beveled
RAPIDIA
FDA 510(k)
FDA Class 2
·Radiology
SUPERCATH Z3V
FDA 510(k)
FDA Class 2
·General Hospital
BI-METRIC/X POR NC 7X115
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·April 27, 2026
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014
TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 15, 2011
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Injury
·ROCHE HEALTH SOLUTIONS INC·Product code LZG·July 9, 2013
FRDM CNSTR HD 36MM T12/14 +6MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·May 13, 2022
FREEDOM CONSTR. LINER +5 SZ 25
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWZ·May 13, 2022
COMPREHENSIVE SHOULDER SYSTEM STANDARD TAPER ADAPTOR
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MBF·February 1, 2017
HYBRID GLENOID BASE 4MM SMALL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·February 1, 2017
PT HYBRID(TM) GLENOID POST REGENEREX(TM) POROUS TITANIUM CONSTRUCT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·February 1, 2017
DEKA LIPOAI
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 4, 2025
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026