13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FaceHeart Vitals Software Development Kit (FH vitals SDK)
FDA 510(k)
FDA Class 2
·Cardiovascular
Merocel
FDA UDI
Beaver-Visitec International, Inc.·30886158011973·Wipe with Wick and Corneal Shield
Patellavator Knee Orthosis
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357236220·
VariAx
FDA UDI
Stryker GmbH·37613153068007·LOCKING SCREWS, CROSS-PIN
GLOBAL
FDA UDI
DEPUY (IRELAND)·10603295106135·GLOBAL GLENOID PUSHER LARGE
JDEVOLUTION PLUS
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 6, 2025
STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35
FDA 510(k)
FDA Class 2
·Cardiovascular
ACUSON
FDA 510(k)
FDA Class 2
·Radiology
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 4, 2014
SUBQ
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code LWS·August 25, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·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