13 results
·
28ms
·
Sources: EU EUDAMED, US FDA
HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Handled Cover / Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102176·MANNIS-BURATTO FLAP PROTECTOR
ENDO GATOR SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BRILLIANCE ICT
FDA 510(k)
FDA Class 2
·Radiology
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021
BD ALARIS¿ SMARTSITE¿ GRAVITY SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·February 9, 2023
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·April 15, 2014
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·January 28, 2013
GEMSTAR PAIN MGE SNG
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·November 22, 2010
BD GEM V/NV 20D 0.2 FLTR
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·July 28, 2022
GEM V/NV NTG 20DP 20PK
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 10, 2020
BD ALARIS¿ SMARTSITE¿ GRAVITY SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·January 20, 2023
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024