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

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A-V IMPULSE SYSTEM MODEL 6060

FDA 510(k)
FDA Class 2 ·Cardiovascular

Edge™ Diamond PC014-4.5F Parallel Chamfer

FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172005876·Diamond dental bur, reusable

RAYLOR(TM) DISSECTING HOOK

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

MODEL 6/01 UV-B FIXTURE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

EXT SET, PUR SMALLBORE BIFUSE W/2 CLAVE¿

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·October 3, 2025

SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

FDA Adverse Event
Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

FDA Adverse Event
Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

FDA Adverse Event
Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

FDA Adverse Event
Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

FDA Adverse Event
Malfunction ·AMSINO MEDICAL (SHANGHAI) CO., LTD.·Product code FMG·September 16, 2020

UNSPECIFIED CENTRAL LINE CONNECTOR

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·July 8, 2025

SECURA DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·February 15, 2013

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·January 19, 2011

HT COMMAND

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code DQX·July 29, 2014

InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.

FDA Recall
Terminated ·Intervascular S.A.S. Zone Industrielle Athelia I La Ciotat Cedex France·Product code DSY·December 9, 2009

94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·August 8, 2012