21 results · 26ms · Sources: EU EUDAMED, US FDA

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JDENTALCARE Implant System

FDA 510(k)
FDA Class 2 ·Dental

EBERLE

FDA UDI
Eberle GmbH & Co. KG·04050052016241·Aggressive Meniscus Side Cutter 4,2-15°gebogen

MAXIM VI KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304205802·

MAXIM® VI KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00887868225871·

SPACELABS MULTI-PARAMETER MODULE

FDA 510(k)
FDA Class 2 ·Cardiovascular

INION OTPS BIODEGRADABLE MINI PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ARCHITECT C8000

FDA Adverse Event
Malfunction ·ABBOTT MFG, INC.·Product code JJE·June 24, 2008

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 6, 2025

PS FEMORAL COMPONENT CLOSED BOX LGE RIGHT 74 MM CEMENTED

FDA Adverse Event
Malfunction ·BIOMET SPAIN, S.L.·Product code JWH·June 3, 2020

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·January 13, 2025

TENDRIL ST

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DTB·January 13, 2014

CRUTCH TIP

FDA Adverse Event
Injury ·MEDLINE INDUSTRIES, INC.·Product code INP·May 30, 2013

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MGB·June 28, 2011

PERF CON TIB BRG LRG 22X60

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

ARCHITECT C4000 ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·January 15, 2020

NON-POROUS PERF TIB TRAY-LGE

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

PERF ANAT TIBIAL STEM 120X14X5

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

ARCHITECT C16000 SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·September 7, 2018

PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 45CM P/N 0250080729 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

TRUE METRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·March 18, 2020