33 results · 24ms · Sources: EU EUDAMED, US FDA

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LIGHT SCALPEL

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Biomet® Knee System

FDA UDI
Biomet Orthopedics, LLC·00880304003941·

WATERLASE MD TURBO PLUS MODEL 7200XXX

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200

FDA 510(k)
FDA Class 2 ·Immunology

Matrixx System

FDA UDI
NEXXT SPINE, LLC·00889929065389·Corpectomy, 14Dx16Wx58H 0°

Matrixx System

FDA UDI
NEXXT SPINE, LLC·00889929038949·Corpectomy, 14Dx16Wx58H 6°

RESERVOIR 1.8ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 4, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 27, 2011

VANGUARD DCM TIBIAL BEARING 18MM X 79/83MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·May 23, 2017

T7 DRIVER CANN AO

FDA Adverse Event
Malfunction ·BIOMET ORTHOPEDICS·Product code LXH·July 14, 2016

PKG, GRASPER FORCEPS, ATRAUMATIC, P/N 0250080323. 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

SERIES-A STANDARD PATELLA

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·March 23, 2018

MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM - BMT SPLINED KNEE STM 20X120

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·November 21, 2016

MAXIM KNEE SYSTEM -FML AUG BLT 65X10ML/LR

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 22, 2017

AGC TOTAL KNEE PROSTHESIS - INTLK FMRL 65 RT

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 22, 2017

OFFSET TIBIAL TRAY - ILOK STEM TIB TRAY 71MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code MBV·March 22, 2017

MAXIM KNEE SYSTEM - FML AUG BLT 65X10MR/LL

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 22, 2017

MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM - BIOMET TIB BLOCK 10MM 71

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 22, 2017

MAXIM KNEE SYSTEM - FMRL AUG BLT 65X6MR/LL

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 22, 2017