23 results · 25ms · 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.

E1 ANTIOXIDANT INFUSED TECHNOLOGY

FDA 510(k)
FDA Class 2 ·Orthopedic

Zavation

FDA UDI
Zavation LLC·00842166183728·RASP, 12mm

GEN4 INTERACTIVE

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828114264·GEN4 INTERACTIVE

OsteoMed

FDA UDI
OSTEOMED LLC·00845694001380·12mm Chin Plate

WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 48mm

FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665037142·

GEN4 INTERACTIVE

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828161848·GEN4 INTERACTIVE

GEN4 INTERACTIVE

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828136723·GEN4 INTERACTIVE

Pediatric BP Cuff (small/child) 17-25cm

FDA UDI
VASOMEDICAL, INC.·00817980020672·Pediatric BP Cuff (small/child) 17-25cm

TRILOGY 202

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code CBK·February 8, 2024

OsteoMed

FDA UDI
OSTEOMED LLC·00845694063180·2.0 System 12mm Chin Plate Sterile Qty 2

SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1

FDA 510(k)
FDA Class 2 ·General Hospital

M2376A DEVICELINK SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 28, 2025

MEGA 8FR. 50CC IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·January 2, 2024

HEARTSTART MRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 26, 2013

ADVIA 1800

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·September 18, 2014

MP70 INTELLIVUE PATIENT MONITOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DSI·May 16, 2011

SMR CEMENTLESS FINNED STEM

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code HSD·July 29, 2021

Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.

FDA Recall
Terminated ·Anjon Holdings·Product code JEC·June 18, 2020

Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.

FDA Enforcement
Class II ·Terminated·Anjon Holdings·August 19, 2020