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