14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZOLL E SERIES
FDA 510(k)
FDA Class 3
·Cardiovascular
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089466900·
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
FDA 510(k)
FDA Class 1
·General Hospital
GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS
FDA 510(k)
FDA Class 2
·Anesthesiology
HYLAMER 10D 52OD X 32ID
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code HRY·May 14, 2013
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code MCX·September 23, 2014
PINNACLE 300 ACET CUP 54MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 13, 2011
FAST-FIX 360 STRAIGHT NDL DELIVERY SY
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code GAT·May 8, 2024
FAST-FIX 360 REVERSED CURVE NDL DELIV
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code GAT·May 8, 2024
FAST-FIX 360 CURVED NDL DELIVERY SYS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code GAT·May 8, 2024
FAST-FIX 360 STRAIGHT NDL DELIVERY SY
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code GAT·May 8, 2024
MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 29, 2024
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025