12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Carex Hybrid Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NA
FDA UDI
Synthes GmbH·10886982157812·3.5MM MEDIAL DISTAL TIBIA PLATE 18 HOLES/251MM-...
RADIONICS VARILINK 2
FDA 510(k)
FDA Class 2
·Radiology
INVIVO DENTAL
FDA 510(k)
FDA Class 2
·Radiology
PINNACLE MTL INS NEUT40IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·March 14, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·July 14, 2011
ALTRX +4 10D 36IDX52OD
FDA Adverse Event
Injury
·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code LPH·July 12, 2013
12/14 ARTICUL 40MM M SPEC+12
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·March 14, 2014
BIOLOX DELTA CER LNR 36MM E
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·May 22, 2025
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