7 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Piccolo Composite Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPACELINE EMCIA, MODEL CU580
FDA 510(k)
FDA Class 1
·Dental
MINI TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·June 3, 2013
GMK HINGE FEMUR SIZE 5 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNAIONAL SA·Product code KRO·August 21, 2014
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 29, 2011
Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, ATS, 2000, with Valve 1) List Numbers 43449-01 and 43449-11; LIST NO. 43449 RECEPTAL CANISTER; CANISTER FOR REUSE, THROW AWAY LINER ONLY; DO NOT FILL 900 ABOVE LINE 2) List Numbers 43423-01 and 43423-21; LIST NO. 43423; RECEPTAL CANISTER; CANISTER FOR REUSE; THROW AWAY LINER ONLY; 1400. 3) List Numbers 43445-01 and 43445-11; LIST NO. 43445; RECEPTAL CANISTER; CANISTER FOR REUSE; THROW AWAY LINER ONLY; DO NOT FILL 1900 ABOVE THIS LINE. 4) List Number 43496-01.
FDA Enforcement
Class II
·Terminated·Hospira Inc.·August 24, 2016