11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DEKA HELIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEALIX PEEK ORTHOCORD
FDA UDI
Medos International Sàrl·10886705007691·HEALIX PEEK Anchor w/ORTHOCORD PEEK Anchor (1) ...
LCP
FDA UDI
Synthes GmbH·10886982156532·LCP PROXIMAL LATERAL TIBIA PLATE 5 HOLES/140MM-...
Curved Femoral Starter Rasp
FDA UDI
Biomet Orthopedics, LLC·00887868508820·
CURVED FEMORAL STARTER RASP
FDA UDI
Biomet Orthopedics, LLC·00880304522244·
NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 3, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 24, 2011
GYNECARE PROLIFT +M POSTERIOR PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·July 12, 2013
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024