15 results
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38ms
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Sources: EU EUDAMED, US FDA
COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Premier K-FILES
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6919053304·FILES PKG 6 31MM 80
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00533041·
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809842821·FOR MEN 30-40 MM HG KNEE HIGH CLOSED TOE LARGE ...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690128991·Revision Tibia Augment Peg Bolt Size 4mm
BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER
FDA 510(k)
FDA Class 1
·Immunology
IM-6 MICROINJECTOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PROFILE BIABUT 4.0 -Ø5.5
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS MANUFACTURING GMBH·Product code DZE·February 24, 2026
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 5, 2025
AC TENDERLINK I
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·October 10, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013
(BASIC) SYSTEM CT9000
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM CO·Product code IZQ·May 16, 2008
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 13, 2011
Esaote brand Formula for Archimed ECG System; part 9704220000.
FDA Recall
Terminated
·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003
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