11 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MULTITEST CD3/CD8/CD45/CD4
FDA 510(k)
FDA Class 2
·Hematology
CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
PLASTIC TUBING CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE KIT
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code BTO·October 25, 2016
PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE KIT
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code BTO·October 25, 2016
PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE KIT
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code BTO·October 25, 2016
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·February 22, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LCAB
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·January 21, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 1, 2014
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physician s directive.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·May 8, 2019
Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-103208 21-103209 21-103210 21-103211 21-103212 21-103215 21-104109 21-104110 21-104111 21-104112 21-104113 21-104114 21-104115 21-104116 21-104117 21-104118 21-104119 21-108110 21-108112 21-108115 21-108117 21-108119 21-108130 21-108132 21-108135 21-108137 21-108139 21-108150 21-108152 21-108155 21-108157 21-108159 21-108251 21-108253 21-108255 21-108257 21-108259 21-108271 21-108273 21-108275 21-108277 21-108279 21-108291 21-108293 21-108295 21-108297 21-108299 21-108391 21-108393 21-108395 21-108397 21-108399 21-109256 21-109260 21-109264 21-109268 21-109272 21-123202 21-123203 21-123204 21-123205 21-123206 21-123207 21-123208 21-123209 21-123210 21-123211 21-123212 21-124309 21-124310 21-124311 21-124312 21-124313 21-124314 21-124315 21-124316 21-124317 US157338 US157340 US157342 US157344 US157346 US157348 US157350 US157352 US157354 US157356 US157358 US157359 US157360 X21-180307 X21-180308 X21-180309 X21-180310 X21-180311 X21-180312 X21-180313 X21-180314 X21-180315 X21-180316 X21-180317 X21-180318 X21-180319 X21-180320 X21-180321 X21-182308 X21-182309 X21-182310 X21-182311 X21-182312 X21-182313 X21-182314 X21-182315 X21-182316 X21-182317 X21-182318 X21-182319 X21-182320 X21-182321 Product Usage: Hip arthroplasty.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019