13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AVENIR CEMENTED HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131259318·NERA, KIT 312 DIR R V BE
Sasmar Vanilla
FDA UDI
Sasmar Pharmaceuticals SPRL·09337213008266·PERSONAL LUBRICANT
OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME
FDA 510(k)
FDA Class 2
·Cardiovascular
INTERFERENTIAL STIMULATOR, MODEL NETWAVE
FDA 510(k)
FDA Class 2
·Physical Medicine
UNKNOWN PATHINDER NXT OR INSTINCT JAVA IMPLANT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·September 24, 2022
CONCERTO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·June 16, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
ALLOFIT SHELL/POLAR SCREWPLUG 50/HH
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWB·August 18, 2008
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
PEDICLE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
PEDICLE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015