19 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMMUNOGLOBULIN A REAGENT SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526785069·EPICOMED ELBOW SUPPORT SILVER I
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950019946·SCISSOR WIRE CUTTING 4-3/4" 12CM
HEARTLINE MINI POTTS VASCULAR SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·B09928002110·HEARTLINE MINI POTTS VASCULAR SCISSORS SQUEEZE ...
HEARTLINE MINI POTTS VASCULAR SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896006980·HEARTLINE MINI POTTS VASCULAR SCISSORS SQUEEZE ...
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209100675·KIT, K9 TACTICAL FIELD w' CHITOGAUZE - COY
NA
FDA UDI
STRYKER CORPORATION·07613252026563·Long Spetzler/Claw Tip
MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BUILD-IT FR
FDA 510(k)
FDA Class 2
·Dental
BD PLASTIPAK 50ML LUER LOCK SYRINGE
FDA Adverse Event
Injury
·BD·Product code FMF·April 29, 2014
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·October 22, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 29, 2007
Various Laparoscopy Packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Various convenience packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
Various convenience packs
FDA Enforcement
Class II
·Ongoing·American Contract Systems, Inc.·September 14, 2022
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 60010741-707; CD1211-36/100006983, 100012542, 100016679, 100031495, 100035634, 100035635, 100042587, 100047090; CD1211-36Q/100004079, 100004081, 100019783, 100035607, 100042591, 100047191; CD1215-36/100006990, 100010230, 100010241, 100010242, 100010244, 100012563, 100012564, 100034631, 100046574, 100046786; CD1215-36Q/100006768, 100006769, 100006770, 100023300, 100030306, 100033794, 100042402, 100046720, 100046904; CD1217-36/100011824; CD1219-36/100002160, 100002864, 100011826; CD1219-36Q/100004071, 100023301; CD2211-36/100006982, 100012536, 100016678, 100031440, 100035629, 100035636, 100042520, 100047192; CD2211-36Q/100004085, 100004087, 100019782, 100035587, 100042575, 100047193; CD2215-36/100006992, 100010224, 100010226, 100010227, 100010228, 100012515, 100012516, 100036606, 100046676, 100046792, 60019063; CD2215-36Q/100006762, 100006763, 100006764, 100023302, 100029180, 100033793, 100042404, 100046789, 100046905; CD2217-36/100011828, 100046991, 60016124-401; CD2219-36/100002139, 100002140, 100002862, 100011830; CD2219-36Q/100023303
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018