23 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGICAL TITANIUM MESH SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZEVO™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169330054·PLATE 3003043 ZEVO 43MM 3 LVL
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00530431·
ZEVO™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000663612·PLATE 3003043 ZEVO 43MM 3 LVL
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523149513·Curette Up Size 1 (Straight Shaft)
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523129102·3.0mm Cleaning Stylet
NAC Y-ADP
FDA 510(k)
FDA Class 2
·General Hospital
DRG AURICA ELISA TESTOSTERONE KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
0009613348-2025-003043
FDA Adverse Event
Injury
·INSTITUT STRAUMANN AG·Product code DZE·March 10, 2025
MultiPolar®
FDA UDI
Zimmer, Inc.·00889024115934·
PRECISE PAIN RELIEVING HEAT PATCH
FDA Adverse Event
Injury
·KIRIBAI KOBAYASHI PHARMACEUTICAL CO, LTD.·Product code IMD·May 26, 2011
QUATTRODE LEAD WIDE SPACED, 30 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZF·February 12, 2015
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 6, 2025
OMNI POD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·June 25, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·February 8, 2011
SYRINGE 20ML 18G 1-1/2IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·November 2, 2020
BD SYRINGE 20ML 18G 1-1/2IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·August 25, 2020
iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code KQO·November 10, 2017
iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713, 800-7714, 800-7715, 800-7101, 800-7102, 800-3938, 800-7157
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·April 18, 2018