23 results
·
19ms
·
Sources: EU EUDAMED, US FDA
EBV-VCA IGG ELISA TEST, MODEL EBG-100
FDA 510(k)
FDA Class 1
·Microbiology
LOCATOR R-Tx
FDA UDI
Zest Anchors, LLC·00840481122873·LOCATOR R-Tx Attachment System, 5.0mm Platform ...
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540602566·Bone Screws, MP, Cross-Pin
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221231376·Unitek Miniature Twin MBT UR Cus 0T/8A DHk 022 MMT
M6-C
FDA UDI
Spinal Kinetics, Inc.·00812388031190·Fin Cutter, 7L (7mm H x 17mm W x 14mm D), G7
CompressAR Jumbo Comfort Disc
FDA UDI
Semler Technologies, Inc.·10815614020217·The CompressAR Jumbo Comfort Disc is a sterile,...
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI
FDA 510(k)
FDA Class 2
·Hematology
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
ADVISOR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL PM, INC.·Product code CCK·December 24, 2008
AISYS
FDA Adverse Event
Malfunction
·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·December 30, 2015
ADVISOR VITAL SIGNS MONITOR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL PM, INC·Product code DQK·April 28, 2010
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 1, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·August 1, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·May 15, 2013
ALTRX NEUT 36IDX54OD
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·March 26, 2013
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 16, 2011
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO·Product code DTB·March 24, 2008
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706
FDA Recall
Terminated
·Tosoh Smd Inc·Product code CDD·November 15, 2019