17 results · 21ms · Sources: EU EUDAMED, US FDA

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EZYPRO ECG Recorder (Model: UG02)

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777501·LUMBAMED PLUS FLEX PAD M SILVER III

OC-Auto

FDA UDI
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917026633·OC-Auto SENSOR io Personal Use Kit for VA Colum...

OC-Auto

FDA UDI
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917021447·Personal Use Kit OC-Auto, for Columbus, OH

4CIS Chiron Spinal Fixation System

FDA 510(k)
FDA Class 2 ·Orthopedic

POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 24, 2024

PORTEX BLUSELECT DILATION TRACHESTOMY KIT

FDA Adverse Event
Malfunction ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code BTO·July 18, 2022

CODEMASTER XL+

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code LDD·October 3, 2014

ASR ACETABULAR CUPS 60

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011

GOBED II

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 9, 2013

CustMbite, Model Number CBT-SRS-UL

FDA Enforcement
Class II ·Ongoing·Dental Choice Holding Llc·August 10, 2022

VALLEYLAB

FDA Adverse Event
Malfunction ·COVIDIEN·Product code GEI·December 11, 2025

INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·June 7, 2023

OT ULTRA2 METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 1, 2016

INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·June 8, 2023

18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017