460 results · 26ms · Sources: EU EUDAMED, US FDA

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Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid

FDA 510(k)
FDA Class 1 ·General Hospital

Blade Scalpel

FDA UDI
KATENA PRODUCTS, INC.·00841668113493·LAMELLAR BLADE #66-60 (BX/5)

RR - UP - Commuter Passenger - zlb

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

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113431·CRESCENT KNIFE DOUBLE BEVEL (BX/5)

GOLDEN-RULE SCALING CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

CONTREET FOAM ADHESIVE/NON-ADHESIVE

FDA 510(k)
FDA Unclassified ·Unknown

MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 8, 2024

PUMP MMT-1880L MM770G BLE MG

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 14, 2024

PUMP 1886 780G OUS BLE PUMP MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·April 30, 2024

MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 22, 2024

MINIMED 740G OUS SYSTEM BLE CONNECT 3.0 MG/DL

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

MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 10, 2024

PUMP 1886 780G OUS BLE PUMP MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 5, 2024

PUMP MMT-1781K 670G V4.11 MG

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·April 24, 2024

MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·April 5, 2024

MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

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

I-STAT ACT CELITE CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE INC.·Product code JBP·March 19, 2024

630G INSULIN PUMP MMT-1715KL 630G

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·March 6, 2024

PUMP 1886 780G OUS BLE PUMP MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 12, 2025

630G INSULIN PUMP MMT-1715KL 630G

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 20, 2024