43 results
·
31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
FDA 510(k)
FDA Class 2
·Cardiovascular
HS Stand. Burr, Ø5.0x125, 80k
FDA UDI
Bien-Air Surgery SA·17630055507263·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450525791·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450177358·
Nitanium® Super Elastic Archwires
FDA UDI
Ortho Organizers, Inc.·00190707088071·.018 Lower Nitanium® Dimple Reverse Curve of Sp...
Portex
FDA UDI
ICU MEDICAL, INC.·15019315048401·
Zavation
FDA UDI
Zavation LLC·00842166175822·8.5mm Tap
Portex
FDA UDI
ICU MEDICAL, INC.·15019315083440·
Tibial Trial UC Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215043056·
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012
LITETOUCH MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
SLEEP APP
FDA 510(k)
FDA Class 2
·Dental
STEM: SMS SOLID STEM LAT SIZE 11
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 10, 2024
1000 ML TPN BAG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·December 9, 2020
VENTED MICRO VOL.INLET, N/S
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·March 28, 2022
250 ML TPN BAG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 21, 2021
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 24, 2015
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 17, 2014
SROM NRH FEM W/PIN XSMRT 66X58
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 17, 2011
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·September 25, 2023