14 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NORMED TITANIUM OSTEOTOMY PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RAM® COR-SUTURE® QUICK LOAD®
FDA UDI
LSI Solutions, Inc.·00850200006476·RAM® COR-SUTURE® QUICK LOAD® SINGLES 3.5MM, NON...
2040 Ceramic Brackets
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746005855·COSMETIC 20/40 UR CUSP 022 T=0 A+8 R=0
Reicodent
FDA UDI
devemed GmbH·04061644048021·Tweezers "London-College"
for introducing medic...
Reicodent
FDA UDI
devemed GmbH·04061644048038·Tweezers "London-College"
for introducing medic...
CARDIOVENTION CORX SYSTEM, MODEL FG 0001
FDA 510(k)
FDA Class 2
·Cardiovascular
WUJIN #3 TIBIAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 27, 2025
PRECISION? MONTAGE? MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 4, 2025
OT PING METER
FDA Adverse Event
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 27, 2013
LINE SET FOR AQUARIUS
FDA Adverse Event
Malfunction
·BAXTER ( 765 )SWITZERLAND SA·Product code FJK·March 17, 2011
COAGUCHEK XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JPA·March 27, 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
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014