12 results · 25ms · Sources: EU EUDAMED, US FDA

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PUMA-G System

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

TFCC Wrist Wrap

FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357239160·

Vu a-POD™

FDA UDI
Seaspine Orthopedics Corporation·10889981038366·39x30mm Trial 16mm 15 deg. The Vu a-POD interve...

BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294

FDA 510(k)
FDA Class 2 ·Neurology

PSA SERIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

TENDRIL SDX

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

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 26, 2011

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 5, 2013

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026

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