43 results · 31ms · Sources: EU EUDAMED, US FDA

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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