13 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BOSS-2000-2 VACUUM ERECTION DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COLOR SPEX
FDA UDI
FGX INTERNATIONAL INC.·00193033441855·
COLOR SPEX
FDA UDI
FGX INTERNATIONAL INC.·00193033441848·
COLOR SPEX
FDA UDI
FGX INTERNATIONAL INC.·00193033441831·
COLOR SPEX
FDA UDI
FGX INTERNATIONAL INC.·00193033441862·
MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COLUMBUS UCR TIBIAL PLATEAU CEMENTED T2+
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code JHW·July 24, 2015
CONCERTO II CRT-D
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·March 20, 2013
UNKNOWN DEPUY LCS STD + PATELLA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HTG·February 24, 2011
NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX ARTICULA
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·March 12, 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
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
FDA Enforcement
Class II
·Ongoing·Stimwave Technologies Inc·September 9, 2020