18 results · 21ms · Sources: EU EUDAMED, US FDA

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LIFE SPINE STAND-ALONE SPACER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SW

FDA UDI
SW SAFETY SOLUTIONS INC.·00616489112815·TrueForm Nitrile Exam Gloves, Extra Small

N/A

FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138125186·SUSPENSORY SUPPORT W/ LEG STRAPS SMALL

LEONE SPA

FDA UDI
LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue

Symmetry Surgical

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482053140·Symmetry® Probe, Sinus Bayonet, Straight, Beade...

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450400920·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450388921·

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450391402·

ZOLL CABLE

FDA UDI
Zoll Medical Corporation·00847946016753·

ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

20/30 PRIORITY PACK W/COPILOT

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code MAV·December 18, 2014

ACCENT DR RF

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 14, 2014

V SERIES MONITOR

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

HEARTSTART MRX - EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 20, 2011

Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices

FDA Enforcement
Class II ·Terminated·Cook Inc.·March 8, 2017

Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Enforcement
Class I ·Terminated·Dexcom Inc·April 20, 2016

Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025