17 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DANYANG HUAYI K2 AND K7 WHEELCHAIRS
FDA 510(k)
FDA Class 1
·Physical Medicine
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014605074·BERCHTOLD OPERON D850, D750 4.25" SOFTCARE PLUS
ITOTAL IDENTITY 15MM STEM DRILL
FDA UDI
Conformis, Inc.·00810933030575·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450054697·
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102070·Shaver, Open 7mm
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023901·PADDLE SPREADER, 7MM
NA
FDA UDI
STRYKER CORPORATION·07613327052411·Male Luer Lock for 6 mm Tubing
POROCOAT PRODIGY HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
PORTABLE INSTENSIVE CARE UNIT
FDA 510(k)
FDA Class 3
·Cardiovascular
RIATA PASSIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEM, INC.·Product code LZG·April 6, 2011
CRYSTALENS
FDA Adverse Event
Injury
·EYEONICS, INC.·Product code HQL·July 22, 2008
PRODIGY LG STAT SHT LT 12.0MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 2, 2016
HANDLE CEV102910R DIA 10MM ANG W/RATCHET [MXI/XOM]
FDA Adverse Event
Injury
·XOMED MICROFRANCE MFG·Product code GCJ·December 20, 2013
PRODIGY LG STAT LNG LT 13.5MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·June 3, 2018
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018