32 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3M SPOTON TEMPERATURE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
Unity Total Knee System
FDA UDI
CORIN LTD·05056139243899·UNITY KNEE™ PS-C INSERT - Size 4 x 12mm
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994235084·SCREW 3120412 4.0 X 12 SELF DRILL FIX
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000889050·SCREW 3120412 4.0 X 12 SELF DRILL FIX
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540491664·BONE SCREW, CROSS-PIN, SELF-TAPPING
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113232·PS Insert, Size 4 x 12mm
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481477771·
Viper
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734021712·Fixed Wire Balloon Dilator
DEPILASE TWIN LASE LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOLOX DELTA CERAMIC FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 16, 2025
HF-RESECTION ELECTRODE, FOR TURIS
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·February 9, 2023
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·September 4, 2024
NI
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWC·May 27, 2011
GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA
FDA Adverse Event
Malfunction
·OBTECH MEDICAL SARL_·Product code LTI·May 20, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
HF-RESECTION ELECTRODE, LOOP
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·March 28, 2023
HF-RESECTION ELECTRODE
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FAS·December 28, 2022
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 26, 2013