10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TruForm
FDA UDI
Rmo, Inc.·00885797099709·MX MLR BDS R/L SE ASIA ASST100
Symmetry Malis®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482140352·Forcep Bipolar Bayonet 7Mm Tip Circular Loop Ir...
NA
FDA UDI
STRYKER CORPORATION·07613327052343·Obturator for Hasson Cannula
VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THROMBOMAX-HS WITH CALCIUM, MODEL T6540
FDA 510(k)
FDA Class 2
·Hematology
SYSTEM 7 DUAL TRIGGER ROTARY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·April 26, 2013
PATROL PUMP
FDA Adverse Event
Malfunction
·ABBOTT NUTRITION·Product code LZH·April 7, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 17, 2008
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