22 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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NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0100600·Caddie, Modular Bone Screws
RITA STARBURST XLI ELECTROSURGICAL DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Santis Pre Bent Rod 5.5mmx60mm
FDA UDI
Lanterna Medical Technologies GmbH·07640159550594·Santis Pre Bent Rod 5.5mmx60mm
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659173323·6.5 Cancellous Bone Shaft Screw, hex, _x000D_...
6.5 Cancellous Bone Shaft Screw, hex, St.Steel, L 60/16 mm
FDA UDI
mahe medical gmbh·EMAH00100100600·6.5 Cancellous Bone Shaft Screw, hex,
St.Ste...
GMA 2.0 Pedicle Screw System
FDA UDI
GRAFTON MEDICAL ALLIANCE, INC.·00810021380261·PRE-BENT ROD, ø5.5 X 60
10 x 60mm Anodized SI Implant
FDA UDI
Osteocentric Technologies, Inc.·00810097800106·10 x 60mm Anodized SI Implant
SANTIS™ PRE BENT ROD 5.5mm X60mm -STERILE
FDA UDI
Lanterna Medical Technologies GmbH·07640159551713·SANTIS™ PRE BENT ROD 5.5mm X60mm -STERILE
Integrity-SI Fusion System
FDA UDI
Lincotek Medical LLC·B57112521010060D0·10 x 60 mm Anodized SI Implant
GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DRAINAGE CATHETER OR FOLEY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
3ML ARTERIAL BLOOD SAMPLE 70 LU+200/CA
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code IQG·November 4, 2020
SYRINGE 50ML LL
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·March 29, 2021
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code LIT·July 29, 2008
AXSYM DIGONIX III
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013
RESOLUTION HEMOSTASIS CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·March 8, 2011
6.0mm Round Fluted Bur, Super Long
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·July 20, 2016
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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