14 results · 26ms · Sources: EU EUDAMED, US FDA

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Emerald Herbst

FDA 510(k)
FDA Class 2 ·Dental

Patellavator Knee Orthosis

FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357236244·

VariAx

FDA UDI
Stryker GmbH·37613153068014·LOCKING SCREWS, CROSS-PIN

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A223624150·22mm H x 36mm W x 24mm L x 15 degrees ALIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A223624120·22mm H x 36mm W x 24mm L x 12 degrees ALIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587A22362480·22mm H x 36mm W x 24mm L x 8 degrees ALIF

OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921

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

RIATA ACTIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

ATTAIN OTW

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 25, 2011

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013

SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

FDA Enforcement
Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

FDA Enforcement
Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026

Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

FDA Enforcement
Class II ·Terminated·Cook Inc.·November 24, 2021