19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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C2 Cryoballoon Ablation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813827·GENUMEDI PRO SILVER SIZE II
OsteoMed
FDA UDI
OSTEOMED LLC·00845694004534·0.9mm Pilot Drill, Logic Jr, J-Latch
VACUTRON
FDA UDI
Allied Medical, LLC·00026072009192·INTERMITTENT SUCTION REGULATORS
SURGICAL TISSUE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REVERE STABILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
TRIATHLON PS FEM COMPONENT, CEMENTED
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·July 8, 2011
ACCU-CHEK COMPACT PLUS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code NBW·September 15, 2008
TRILOGY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 11, 2025
G7 VIVACIT-E
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 11, 2025
G7 OSSEOTI
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 11, 2025
TRILOGY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 11, 2025
VIDAS® TOXO IGM
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LYR·December 7, 2016
VIDAS® TOXO IGM
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code LYR·December 5, 2016
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·June 23, 2020
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 20, 2017
Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Enforcement
Class II
·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022