21 results · 29ms · Sources: EU EUDAMED, 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