16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OLYMPUS BF TYPE UC160-OL8
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bard® Nasogastric Sump Tube
FDA UDI
C. R. Bard, Inc.·00801741052255·Bard® Nasogastric Sump Tube
AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 140mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665010398·
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20421401·Arch wires Titanol Superelastic Straight-Arch-F...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192886·14mm X 100mm Stem Pilot
MENICON PROGENT REMOVER
FDA 510(k)
FDA Class 2
·Ophthalmic
COM-PATCH
FDA 510(k)
FDA Class 2
·Neurology
BARD® NASOGASTRIC SUMP TUBE
FDA Adverse Event
Malfunction
·C.R. BARD INC. (COVINGTON) -1018233·Product code BSS·April 14, 2026
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 9, 2013
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·May 8, 2008
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 6, 2011
ARROW CVC SET: 2-LUMEN 4 FR X 5 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code DQY·September 10, 2024
ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code FOZ·August 8, 2023
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
FDA Recall
Open, Classified
·GE Medical Systems, LLC·Product code ITX·November 10, 2022
Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 28, 2022
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