24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
FDA 510(k)
FDA Class 1
·Microbiology
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964013209·Endo Carry-on Procedure Kit includes Olympus 5-...
Spot-On Etch
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783000825·Spot-On Etch Bulk 12 gram syringe, 50 tips
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001460·artVeneer life lower anteriors, UIM, D2
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00146011·
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361008514·PedFuse Respond, CNL, 7.0mm x 60mm
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·April 16, 2014
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
FDA 510(k)
FDA Class 2
·Clinical Toxicology
VERSABOND BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·December 10, 2025
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·May 23, 2026
TUFF IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·March 15, 2026
ASSURITY MRI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWP·September 28, 2025
TOTAL ASR ACET IMP SIZE 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 13, 2013
MICROVASIVE GOLD PROBE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA·Product code KNS·February 25, 2011
MENIVAC WITH INTEGRATED CABLE
FDA Adverse Event
Other
·ARTHROCARE CORP.·Product code GEI·February 21, 2008
Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·January 7, 2016
Reyito Urological Pack, Catalog number 900-1460. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·October 8, 2014
Reyito Urological Pack, Catalog number 900-1460. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class II
·Terminated·Customed, Inc·April 20, 2016