12 results
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23ms
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Sources: EU EUDAMED, US FDA
ELECSYS ANTI-TG TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120206721·Carbide, cylinder round, crown cutter for preci...
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 15, 2025
HELIODENT VARIO
FDA 510(k)
FDA Class 2
·Dental
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3 ML BD LUER-LOK¿ SYRINGE WITH BD SAFETYGLIDE¿ SAFETY NEEDLE 25 G X 5/8 IN
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMI·September 29, 2017
5MM X 32CM STRYKEPROBE SPOON TIP
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GEI·March 26, 2013
SWAN- GANZ, VIP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCE·Product code DYG·March 7, 2011
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS, AB·Product code LXB·March 27, 2008
COLUMBUS UCR TIBIAL PLATEAU CEMENTED T2+
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code JHW·July 24, 2015
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
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024