33 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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