14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
L-VARLOCK
FDA 510(k)
FDA Class 2
·Orthopedic
ANGEL WING RESECTION GUIDE
FDA UDI
Conformis, Inc.·00810933030360·
Clamp, Hysterectomy, model Z 30.5cm strongly curved shanks angled
FDA UDI
Geister Medizintechnik GmbH·04057034373200·Clamp, Hysterectomy, model Z
30.5cm...
LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
FDA 510(k)
FDA Class 2
·Microbiology
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK INC·Product code FGE·February 24, 2017
ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK INC·Product code NIO·July 25, 2017
TENDRIL STS
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·April 26, 2013
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL PUERTO RICO, B.V.·Product code MGB·April 22, 2011
SOFT TOUCH II
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 22, 2008
1.5MM TI HEADLESS COMPRESSION SCREW 18MM-STERILE
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HWC·April 14, 2016
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015