26 results · 24ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MyPAO Planning Report

FDA 510(k)
FDA Class 2 ·Radiology

N/A

FDA UDI
STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003449·Diagnostic EP Catheter, Cournand curve, 4 elect...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694016216·Modular Cannula, Mandible

DUVAL COLLIN FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896084896·DUVAL COLLIN FORCEPS HORIZONTAL SERRATED TIPS

3M COMPLY 1228 GAS PLASMA INDICATOR TAPE

FDA 510(k)
FDA Class 2 ·General Hospital

MODEL 445SI-64E QUADRATURE WRIST COIL

FDA 510(k)
FDA Class 2 ·Radiology

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014

SPRINT QUATTRO SECURE

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 1, 2013

bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

FDA Enforcement
Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL

FDA Enforcement
Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·March 27, 2024

PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TEMP.

FDA Adverse Event
Malfunction ·INTEGRA NEUROSCICENCS IMPLANTS SA·Product code GWM·October 6, 2017

MICROPUNCTURE TRANSITIONLESS ACCESS SET

FDA Adverse Event
Injury ·COOK INC·Product code DYB·September 26, 2024

MICROPUNCTURE TRANSITIONLESS ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·September 30, 2024

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Injury ·COOK INC·Product code DYB·December 6, 2024

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Injury ·COOK INC·Product code DYB·November 5, 2024

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·December 26, 2024

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Injury ·COOK INC·Product code DYB·November 13, 2024

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·December 31, 2024

MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DYB·December 6, 2024