23 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.

RenaPure Endotoxin Retentive Filter

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

OMNI Mod Hip

FDA UDI
Omni Life Science, Inc.·00841690103035·Modular Neck 13 degree Anteversion, Medium 47.5

OsteoMed

FDA UDI
OSTEOMED LLC·00845694036719·FPS 10mm Cannulated Metatarsal Reamer

Meridian

FDA UDI
Seaspine Orthopedics Corporation·10889981309930·Trial Rasp, 39mm x 30mm x 14mm, 10 Deg

Meridian

FDA UDI
Seaspine Orthopedics Corporation·10889981215620·No-Profile Interbody, 39mm x 30mm x 14mm, 10 Deg

3D Printed Interbody Systems

FDA UDI
Seaspine Orthopedics Corporation·10889981304058·2-Hole No-Profile Interbody, 39mm x 30mm x 14mm...

X SERIES

FDA UDI
Zoll Medical Corporation·00847946019266·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...

X SERIES

FDA UDI
Zoll Medical Corporation·00847946062095·X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP...

X SERIES

FDA UDI
Zoll Medical Corporation·00847946004361·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...

Tecomet

FDA UDI
TECOMET INC.·00841435121119·RONGEUR STRAIGHT

DRILL, AO, STERILE 4, 2X340 MM

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·September 23, 2011

VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE

FDA 510(k)
FDA Class 2 ·Microbiology

CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),

FDA 510(k)
FDA Class 2 ·Anesthesiology

Specials

FDA UDI
Seaspine Orthopedics Corporation·10889981331078·Lollipop Trial, Anterior-Angled, 23mm x 14mm x ...

BLACKHAWK Cervical Spacer System

FDA UDI
Choice Spine, LP·00840996164702·BLACKHAWK,STERILE,CONVEX,14X12X10

Specials

FDA UDI
Seaspine Orthopedics Corporation·10889981441500·Lollipop Trial 23mm x 14mm x 55mm, 10°

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

CLARION IMPLANT

FDA Adverse Event
Injury ·ADVANCED BIONICS, LLC·Product code MCM·July 15, 2013

CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, 674-052, 674-059, 674-061. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

FDA Enforcement
Class II ·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015