14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114155·KRATZ POLISHER 23GA END (PK/10)
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113783·AIR INJECT CANNULA 25GA
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756059725·CAST BOOT
BI-OSTETIC
FDA 510(k)
FDA Class 2
·Orthopedic
TAUT-INSUFFLATION NEEDLE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NEXGEN TM MONOBLOCK CR TIBIA SIZE NBR4 - 12
FDA Adverse Event
Injury
·ZIMMER TMT·Product code JWH·June 25, 2013
CAPSUREFIX
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
SERI SURGICAL SCAFFOLD (US)
FDA Adverse Event
Injury
·ALLERGAN·Product code OXF·October 23, 2014
LOCKSCR Ø5 SELF-TAP L36 TAN
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·January 1, 2020
CORTSCR Ø4.5 SELF-TAP L36 TI
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·December 31, 2019
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012