23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DOBBHOFF DUAL PORT FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902164040·DISTRACTOR 9112511 SGL BARREL 20/14MM OS
Biosens cartridges Purple Pink
FDA UDI
PERFLEX LTD·07290110501617·box of 6 identical cartridges sealed in a vacuu...
2530 BALLOON CONTROLLER
FDA UDI
HANS RUDOLPH, INC.·00874750008957·2530AF INFL-3BALLOON CTRL 230V
Haptoglobin RID plate package
FDA UDI
KENT LABORATORIES INC·B1761125·Radial immunodiffusion plate package for Human ...
T-Crystal cartridges Amhari/Purple Pink
FDA UDI
PERFLEX LTD·07290110500214·Box of 6 identical cartridges sealed in aluminu...
Mallet
FDA UDI
ELLIQUENCE, LLC·00846338002572·
TLIF/PLIF Disc Prep
FDA UDI
Life Spine, Inc.·00190837086930·
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAR·March 25, 2026
T-Crystal cartridges Amhari/Purple Pink
FDA UDI
PERFLEX LTD·07290110506117·5 identical cartridges sealed in a vacuum bag ;...
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025
WATERLASE MILLENNIUM
FDA 510(k)
FDA Class 2
·Dental
MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
Tandry Locking Plate System
FDA UDI
MICROWARE PRECISION CO., LTD.·04719873105878·3.5mm Locking Medial Distal Tibial Plate, 4 Hol...
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·May 14, 2013
PREVELLE SILK (NON-ANIMAL STABILIZED HYLAN B GEL WITH LIDOCAINE HCL) INJECTION
FDA Adverse Event
GENZYME BIOSURGERY (RIDGEFIELD)·Product code LMH·April 4, 2011
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER COMBO
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DRS·August 8, 2008
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·April 10, 2025
MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
FDA Enforcement
Class II
·Terminated·Ecolab Inc·February 19, 2014
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
FDA Enforcement
Class II
·Ongoing·Medtronic Inc·January 21, 2026