13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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InsufflatOR Needle
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551057315·Metal Connector, 142000, 146001/146002
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377020490·Cadwell ApneaTrak Adult Effort Belt Sensor, Chest
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702563184·ELVAREX 2/KNEE HIGH/PROFILE-SLANT-CLOSED TOE/DO...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613085339·Shea Incision Knife, Tapers 1.5mm to 0.25mm, An...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702253818·ELVAREX 2/THIGH HIGH/SLANT, CLOSED TOE, KNEE FU...
ZEOS
FDA UDI
SANTA BARBARA IMAGING SYSTEMS, INC.·00812231031247·ARTHROSCOPE, 2.7MM 0DEG
IMAGE MEDICAL ACQUISITION STATION (IMAS)
FDA 510(k)
FDA Class 2
·Radiology
LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·October 2, 2014
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·June 17, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 24, 2013
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