24 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776295509·ECONOMY LINE Adson Forceps 4.75"
VERSANT BOARDROOM CLASSICS
FDA UDI
FGX INTERNATIONAL INC.·00193033335246·
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 9, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 14, 2024
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 18, 2008
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 9, 2025
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 12, 2026
E REIN MUR 6.0MM 71-13262
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code BTR·October 23, 2015
E REIN MUR 6.0MM 71-13262
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code BTR·October 22, 2015
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 8, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014
AGILITY POLY REG 1/2 CLMN SZ4
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSN·May 20, 2011
BIOMEDICS 1 DAY (52%) STRIP (OCUFILCON B)
FDA Adverse Event
Injury
·COOPERVISION CARRIBEAN CORPORATION·Product code MVN·August 29, 2019
UNK - CONSTRUCTS: FEMORAL NAIL
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·January 9, 2026
UNK - NAIL HEAD ELEMENTS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·January 9, 2026
UNK - NAIL HEAD ELEMENTS: PFNA BLADE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HSB·January 9, 2026
UNK - CONSTRUCTS: LCP
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·January 9, 2026