16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OASYS(r) System
FDA 510(k)
FDA Class 2
·Orthopedic
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704283389·BABY RIBBON RETRACTOR 7 1/2" x 1"
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100233·LIEBERMAN ASPIRATING SPECULUM V-WIRE
OsteoMed
FDA UDI
OSTEOMED LLC·00845694047036·PrimaLIF LLIF PEEK Implant, 17mm X 18mm X 55mm,...
MaxFuse,VBR, 12 (D) x 14 (W) x 33 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468056292·12 (D) x 14 (W) x 33 (H)
AIDI DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
FDA 510(k)
FDA Class 2
·Hematology
UNKNOWN VALTRAC PRODUCT
FDA Adverse Event
Malfunction
·UNITED STATES SURGICAL·Product code GDW·September 29, 2011
UNKNOWN VALTRAC PRODUCT
FDA Adverse Event
Malfunction
·UNITED STATES SURGICAL·Product code GDW·September 29, 2011
UNKNOWN VALTRAC PRODUCT
FDA Adverse Event
Malfunction
·UNITED STATES SURGICAL·Product code GDW·September 29, 2011
RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION
FDA Adverse Event
Injury
·BAUSCH & LOMB INCORPORATED·Product code LPN·February 18, 2020
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 6, 2011
CARELINK
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DXY·June 7, 2013
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (CE)·Product code MCX·October 8, 2014
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020