21 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016
FDA 510(k)
FDA Class 2
·Dental
GELPI NEROMA RETRACTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896049000·GELPI NEROMA RETRACTOR
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776389291·Gelpi Crossover Retractor 5 1/2", 4mm tips
APK
FDA UDI
APK Technology Co.,Ltd.·06946725547229·Disposable ECG Lead Wire
Monoblock Tibial Trial PS Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215042455·
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHETIC GLASS BONE GRAFT MATERIAL
FDA 510(k)
FDA Class 2
·Dental
INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 8, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 17, 2014
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code MTA·May 17, 2011
M2A-MAGNUM MODULAR HEAD SZ 48MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 18, 2012
TAPERLOC MICROPLASTY FEMORAL 9.0MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 18, 2012
M2A-MAGNUM 42-50M TAPER INSERT +3
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 18, 2012
M2A-MAGNUM PF CUP 54ODX48ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 18, 2012
GALAXY G3 MINI 1MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·July 21, 2021
GALAXY G3 MINI 1MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·July 21, 2021
MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·December 26, 2012
DISPOSABLE STERILE HIGH TEMPERATURE ELECTROCAUTERY (HTC) F7244
FDA Adverse Event
Injury
·FIAB SPA·Product code GEI·October 12, 2023
MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
FDA Recall
Terminated
·Integra LifeSciences Corporation·Product code HBL·November 5, 2012
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 28, 2026