12 results
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18ms
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Sources: EU EUDAMED, US FDA
SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
NuVasive
FDA UDI
Nuvasive, Inc.·00887517389077·Universal Rasp, Angled
ORA Implant Abutment 2.0mm Cuff (BD)
FDA UDI
STERNGOLD DENTAL LLC·00841549111556·The ORA System is indicated for use with dental...
Convaid
FDA UDI
CONVAID PRODUCTS, INC.·10840117400150·
SEARS MODEL JCS IN-THE-EAR HEARING INSTRUMENT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
IN-THE NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
SOFTCLIX® LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·November 22, 2010
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014
LD304 MATERNITY BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code HDD·November 30, 2012
Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company. Product is intended to be used as an accessory to the leads component of ANS SCS systems, functioning to secure the lead to the fascia or interspinous/supraspinous ligament.
FDA Recall
Terminated
·Advanced Neuromodulation Systems, Inc·Product code GZB·February 22, 2010
MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): A0030/1; A0031/1; A0032/1; A0033/1, Cardio Life Research s.a., Green Hill, Hoge Wei, 16, B-1930 Zaventem, Belgium. Indicted for the retraction of the atrium walls during mitral or tricuspid cardiac surgery.
FDA Recall
Terminated
·St. Jude Medical Cardiovascular Division·Product code DWS·January 26, 2011
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013