18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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