18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Blue Sky Bio Aligner
FDA 510(k)
FDA Class 2
·Dental
Invacare® Barbed Brass Fire Break Connector
FDA UDI
INVACARE CORPORATION·00841447103325·Invacare 1180107 Connector Barbed Brass Fire Br...
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304439191·
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868239458·
Super Upper Limbs Versalock Plating System
FDA UDI
GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258663494·VERSALOCK SPANNING PLATE 195.0mm, ANGLED
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0
FDA 510(k)
FDA Class 2
·Neurology
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
FDA 510(k)
FDA Class 2
·Microbiology
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·February 5, 2018
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·February 6, 2018
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·December 19, 2018
EUFLEXXA
FDA Adverse Event
BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.·Product code MOZ·December 7, 2012
HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD K
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code MSD·June 13, 2013
MULTI-LINK RX ZETA CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·July 27, 2011
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDW·September 29, 2008
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 7, 2014
NEEDLE 21GA 1-1/2IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·February 9, 2021
Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]
FDA Enforcement
Class II
·Terminated·Ecolab Inc·October 31, 2018
STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·December 19, 2012