12 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Premier REAMERS
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6919053037·WSL REAMERS PKG 6 25MM 35
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00530371·
MicroAire®
FDA UDI
Microaire Surgical Instruments LLC·00847399005304·SST TWIST DRILL, AO TYPE, 3.5mm Dia. x 170mm
JEWEL CAST III
FDA 510(k)
FDA Class 2
·Dental
EXCEL A.V FISUTAL NEEDLE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DASH Apex 4 Centrifuge, VWR
FDA UDI
DRUCKER DIAGNOSTICS·00810052864365·General purpose laboratory centrifuge for sampl...
VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GP75 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LON·January 14, 2019
ALTRX +4 10D 36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·April 11, 2013
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·April 13, 2011
LAPAROSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDOSURGERY INC.·Product code GDO·May 16, 2008
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