18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARROW-LOK DIGITAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
2010 4 WAY STOPCOCK
FDA UDI
HANS RUDOLPH, INC.·00874750009633·2010C 2POS4W.875FB 1.375/1.125
UNIMAX
FDA UDI
PARAMOUNT SURGICALS, INC.·00852647007320·HORIZONTAL PLATE STANDARD 67.5 MM
Algovita®
FDA UDI
Greatbatch Ltd·00821329580246·Algovita® 12 Electrode Percutaneous Lead Kit - ...
REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
FDA 510(k)
FDA Class 2
·Cardiovascular
EASYRA UREA NITROGEN AND CREATININE REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HAHN TAPERED IMPLANT Ø5.0 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 1, 2024
HAHN TAPERED IMPLANT Ø5.0 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 1, 2024
HAHN TAPERED IMPLANT Ø5.0 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 10, 2025
HAHN TAPERED IMPLANT Ø5.0 X 8 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 14, 2025
HAHN TAPERED IMPLANT Ø5.0 X 8MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 5, 2023
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·May 14, 2013
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 10, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·May 26, 2011
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·August 31, 2018
BD POSIFLUSH¿ SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·March 25, 2020
U BY KOTEX SLEEK
FDA Adverse Event
Malfunction
·K-C AFC MANUFACTURING, S. DE R.L. DE C.V·Product code HEB·June 27, 2018
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ, mg/dl, REF: 1004219; Pump, t:slim X2, Clinical Use Only, REF: 1004484; Pump, t:slim X2, Control-IQ, REF: 1005611; Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613; Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615; Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617; Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379; Pump, t:slim X2, Control-IQ 7.4, REF: 1006402; Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406; Pump, t:slim X2, Control-IQ 7.4, REF: 1006408; Pump, t:slim X2, Basal-IQ, , REF: 1006419; Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420; Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535; Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537; Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255; Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256; Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257; Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258; Pump, t:slim X2, Basal-IQ, REF: 1010004; Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006; Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007; Pump, t:slim X2, Control-IQ, REF: 1010009; Pump, t:slim X2, Control-IQ Replacement, REF: 1010010; Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011; Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012; Pump, t:slim X2, Control-IQ, REF: 1012867; Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868; Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869; Pump, t:slim X2, Control-IQ 7.8, REF: 1013195; Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196; Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197; Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198
FDA Enforcement
Class I
·Ongoing·Tandem Diabetes Care, Inc.·September 3, 2025