17 results · 20ms · 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.

MODEL 2500A PALMSAT PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

Batrik Brush/White/BD 5+6mm/BL 50mm

FDA UDI
Batrik Medical Manufacturing Inc·00690521007758·Brush/White/BD 5+6mm/BL 50mm/OL 50cm - Asymetri...

mahe medical GmbH

FDA UDI
mahe medical gmbh·04050659181847·T-plates, right angle _x000D_...

T-plates, right angle 56mm/4x4 holes

FDA UDI
mahe medical gmbh·EMAH00200500560·T-plates, right angle 56mm/4...

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710420500560·Anterior Lateral Wedge Osteotomy Guide, 50mm x ...

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710410500560·Anterior Closing Wedge Osteotomy Guide, 50mm x ...

PERSONA® Persona SoluTion™

FDA UDI
Zimmer, Inc.·00889024231276·

PERSONA® Persona SoluTion™

FDA UDI
Zimmer, Inc.·00889024231283·

UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 10, 2019

INCEPTA

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 10, 2013

THERA-I DR

FDA Adverse Event
Death ·MEDTRONIC MED REL, INC.·Product code DXY·May 20, 2008

E SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 1, 2011

Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

FDA Enforcement
Class II ·Terminated·Unomedical As·November 9, 2016

Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024