29 results
·
27ms
·
Sources: EU EUDAMED, US FDA
CLICKFINE PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
Ackermann
FDA UDI
Preat Corporation·00842092107478·Ackermann BL Clip SS
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699427·GENUMEDI SILVER SIZE VIII
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112779·BARRON VACUUM PUNCH 8.0MM
Explorer TO
FDA UDI
Seaspine Orthopedics Corporation·10889981289270·8mm Trial, 11mm Height
VISICOIL MR
FDA UDI
Izi Medical Products, LLC·B887SNMR05001021080·0.5mm x 1cm Platinum Fiducial Marker
Pre-Loaded...
NIAGARA® Lateral Access System
FDA UDI
VB Spine LLC·10888857519992·Straight Blade, Size 20x120 mm
MEDPOR COATED TEAR DRAIN
FDA 510(k)
FDA Unclassified
·Unknown
AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018
NORIAN REINFORCED FAST SET PUTTY/3CC
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code GXP·May 19, 2015
ZIMMER KINECTIV MODULAR NECK
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWA·April 26, 2013
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·September 19, 2014
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 19, 2011
HAHN TAPERED IMPLANT 4.3 X 11.5
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 15, 2022
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019
SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and reamers are specially designed surgical accessories to help the surgeon cut and drill bone and bony structures. Reprocessed surgical accessories are indicated for use in patients requiring surgery involving bone and bony structures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 18, 2015
Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2020
syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015