14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AXS Vecta 46 Intermediate Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Shannon Recta Larga Round Shank
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613289600·
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112878·CORNEAL TREPHINE BLADE6.5MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112465·BARRON VACUUM TREPHINE 6.5MM
PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15
FDA 510(k)
FDA Class 2
·Anesthesiology
BAYONET FORCEPS BIPOLAR IRRIGATING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DELTA LINERS & ACCESSORIES
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code LPH·May 26, 2026
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·March 8, 2022
INTRACRANIAL KIT 110-4BT
FDA Adverse Event
Other
·INTEGRA NEUROSCIENCES·Product code GWM·October 9, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JEY·July 2, 2013
ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 18, 2026
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021