15 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PROVOX FREEHANDS FLEXIVOICE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515065994·Kocher Fcps, str, 5 1/2"
Mckesson
FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·00612479188204·GLOVE, EXAM POLYMER LTX PF XSM
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515018921·Kocher Fcps, str, 5 1/2" 1 x 2 th
IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR
FDA 510(k)
FDA Class 2
·Radiology
RXPEAKFLOW
FDA 510(k)
FDA Class 2
·Anesthesiology
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·February 15, 2019
DELTA CER HEAD 12/14 36MM +5
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code LZO·June 3, 2013
UNKNOWN DEPUY ARTICUL/EZE FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·June 8, 2011
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 3, 2014
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·July 2, 2019
VANGUARD COMPLETE KNEE SYSTEM- PS CLSD INTLK FEM-RT 67.5
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·April 18, 2017
BIOMET TIBIAL TRAYS - COCR I-BEAM TRAY 67MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·April 18, 2017
VANGUARD PATELLA COMPONENTS - SERIES A PAT STD 28 3 PEG
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·April 18, 2017
PKG, 10MM CLIP APPLYING FORCEPS, P/N 0250080558. 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