18 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OCTAGON BL RC Abutment, 0°, Ø 5.0 mm L 6.0 mm, GH 3.0 mm, cementable basic screw
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50221081·BL RC Abutment, 0°, Ø 5.0 mm L 6.0 mm, GH 3.0 m...
OCTAGON BL RC Abutment, 0°, Ø 5.0 mm L 6.0 mm, GH 3.0 mm, cementable basic screw
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·XXXX50221089·BL RC Abutment, 0°, Ø 5.0 mm L 6.0 mm, GH 3.0 m...
HANISCH MEDICAL
FDA UDI
Hanisch Medical Ltda·07901089809665·HO8-LID(37-50) F/ DRILLS.-STANDER---AMBER
MedGyn Uterine Curette
FDA UDI
MEDGYN PRODUCTS, INC.·M803022108·8mm rigid curved vacuum curette
Whistle Tip
FDA UDI
COOK INCORPORATED·00827002140332·Whistle Tip Ureteral Catheter (Right)
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776371913·Bimanual Aspirating Unit, 21g Cannula Tip, Curved
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112779·BARRON VACUUM PUNCH 8.0MM
ESOP HA FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDPOR COATED TEAR DRAIN
FDA 510(k)
FDA Unclassified
·Unknown
NA
FDA UDI
STRYKER CORPORATION·04546540992451·10.8mm x 24.1mm Coring Tool
3.0MM DRILL BIT
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HTW·July 31, 2025
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·October 21, 2023
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·March 26, 2013
M-1 COT - BASE HIGH LOAD 28
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 10, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·March 25, 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