19 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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SAPH-LOOP LIGATING LOOP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Safco Pure
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310224103·Safco Pure 100% cotton non-woven sponges, 4" x ...
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994325570·CONNECTOR 7022410 LAT CONN SS 6.35 12MM
LEONE SPA
FDA UDI
LEONE SPA·08033707066453·LIGAT SLIDE LOW FRICTION ICE XSMALL
Benacel Plus
FDA UDI
UNICARE BIOMEDICAL INC.·D767B0224101·BenaCel® Plus Hemostatic Dressing is provided i...
INFINITY HBA KIT, MODELS 537-A, 537-B
FDA 510(k)
FDA Class 2
·Hematology
FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
FR MARSEILLE
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010
MODULAR LATERALIZED TAPERLOC FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·May 18, 2018
TAPERLOC FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·April 9, 2018
M2A-MAGNUM TAPER ADAPTOR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·April 9, 2018
UNKNOWN DEPUY METAL LINER
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code KWA·March 27, 2013
HOME CHOICEPRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 17, 2011
EMBRACE PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·March 26, 2008
UNK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·July 22, 2011
FR VILLEURBANNE
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010
I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014