18 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH
FDA 510(k)
FDA Class 2
·Cardiovascular
PROFYLE
FDA UDI
Stryker GmbH·34546540244544·BONE SCREWS, EMERG., CROSS-FIT, SELF-T.
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0140070·T-Handle, T30, Locking Cap Adjuster
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap
FDA 510(k)
FDA Class 2
·General Hospital
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
LRG TAP PRI MOD NCK 8DEG 38MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·January 14, 2013
ACCU-CHEK D-TRONPLUS
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·November 19, 2010
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·July 3, 2014
HEMOCHRON SIGNATURE ELITE
FDA Adverse Event
Malfunction
·ACCRIVA DIAGNOSTICS·Product code JPA·May 25, 2016
WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·April 22, 2015