494 results · 28ms · Sources: EU EUDAMED, US FDA

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BrainInsight

FDA 510(k)
FDA Class 2 ·Radiology

10M - General Purpose

FDA UDI
Certified Safety Manufacturing, Inc.·00766588020143·General Purpose - 10 Metal

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112830·BARRON VACUUM PUNCH 9.5MM

RR - UP - Commuter Passenger - zlb

FDA UDI
Certified Safety Manufacturing, Inc.·00766588024110·RR - UP - Commuter Passenger - zlb

STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE

FDA 510(k)
FDA Class 2 ·Neurology

PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE

FDA 510(k)
FDA Class 2 ·General Hospital

MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 26, 2024

PUMP MMT-1884L MM780G BLE 3.0 MG/ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 17, 2024

PUMP MMT-1885A OUS BLE PUMP MMOL/L

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 7, 2024

MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 29, 2024

MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 3, 2025

I-STAT ACT KAOLIN CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE INC.·Product code JBP·May 7, 2024

640G INSULIN PUMP MMT-1711K

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 23, 2024

640G INSULIN PUMP MMT-1711K

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 21, 2024

PUMP MMT-1884L MM780G BLE 3.0 MG/ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 6, 2024

I-STAT TROPONIN (CTNI) CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE INC.·Product code MMI·October 29, 2024

MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 2, 2024

PUMP 1886 780G OUS BLE PUMP MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 7, 2024

640G INSULIN PUMP MMT-1712K

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 23, 2024

MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 1, 2024