12 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
FDA 510(k)
FDA Class 1
·General Hospital
Dropper Urine Chemistry Control Level 1 Set 3x10mL
FDA UDI
QUANTIMETRIX CORPORATION·00896863002196·The Dropper Urine Chemistry Control is intended...
TORPICALGIN
FDA 510(k)
FDA Class 2
·Dental
LIASYS 450
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMISTEM-H HA COATED STD STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 28, 2017
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code DTB·January 13, 2014
TM MONOBLOCK TIBIA
FDA Adverse Event
Injury
·ZIMMER TMT·Product code JWH·May 29, 2013
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 28, 2011
ALINITY I B12 REAGENT KIT
FDA Adverse Event
Malfunction
·A.I.D.D LONGFORD·Product code CDD·May 14, 2021
TOSOH ST AIA 25-OH VITAMIN D PRETREATMENT SET
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code MRG·April 19, 2018
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·February 14, 2024
PKG, PKG, PERITONEAL SCISSORS, P/N 0250080262. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014