14 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CORRUGATED FLEXIBLE POLYETHYLENE & EVA
FDA 510(k)
FDA Class 1
·Anesthesiology
Nasal Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668108543·NASAL SPECULUM CHILD
Blue Phantom PT
FDA 510(k)
FDA Class 2
·Radiology
COMMANDER 111, MODEL CD300-CD399
FDA 510(k)
FDA Class 2
·Cardiovascular
WECK BP TI SMALL 10/CART 180/BOX W/TAPE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·January 22, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 15, 2012
REVEAL DX
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DSI·August 10, 2010
NEURO SPG-1X1"-STERILE- 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·February 20, 2025
NEURO SPNG-1/2X3"-STRL- 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025
NEURO-SP-1/2X1/2"-STRL 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025
NEURO-SP-1/2X1/2"-STRL 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·January 20, 2025
NEURO-SP-1/2X1/2"-STRL 20/CS
FDA Adverse Event
Malfunction
·MEDSORB DOMINICANA, S.A.·Product code EFQ·February 7, 2025
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024