11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire, Cleaner Plus Handpiece with 135cm Maceration Wire, Cleaner Plus Aspiration Canister
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114063·MCINTYRE-BINKHORST CAN 25GA ANG RT PK/10
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·March 3, 2003
ISO-GARD CLEARAIR MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
UNDUS MALE LATEX CONDOM (WITH FLAVORING)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·August 12, 2011
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·November 4, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013
TRULIANT KNEE COMPONENT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 13, 2025
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
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