18 results · 22ms · Sources: EU EUDAMED, US FDA

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PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Anesthesiology

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780379263·Integra® Jarit® Lahey Gall Duct Forceps, 7-1/2"

OsteoMed

FDA UDI
OSTEOMED LLC·00845694003858·Reconstruction Plate, Full, 5 x 20 x 5 Hole

ADSON DRESSING FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896076372·ADSON DRESSING FORCEPS TUNGSTEN CARBIDE DUST TI...

Reliance® C

FDA UDI
VB Spine LLC·10888857580701·Trial 12x14x8 mm, 0°

OsteoMed

FDA UDI
OSTEOMED LLC·00845694064729·2.4 System 5 x 20 x 5 Hole Reconstruction Full ...

INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS

FDA 510(k)
FDA Class 2 ·Dental

FRONTIER DEVICES NEURO SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2025

ENDOTAK RELIANCE

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVY·October 3, 2014

ENDURANT

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code MIH·May 31, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 25, 2011

Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog Number; WST 140205-00; Distributed by Micrus Endovascular Corporation. San Jose, CA

FDA Recall
Terminated ·Micrus Endovascular Corporation·Product code DQX·September 8, 2006

VENTED AUTOFEED CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 23, 2014

PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

MyLab30CV Ultrasound Imaging System; model 9807300001.

FDA Recall
Terminated ·Biosound Esaote, Inc.·Product code IYN·May 6, 2005

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013