12 results · 19ms · Sources: EU EUDAMED, US FDA

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CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Pro Advantage

FDA UDI
NATIONAL DISTRIBUTION & CONTRACTING, INC.·M220P0725043·PA STOCKINETTE COTTON 4X25YD - (EA)

IDI-STREP B ASSAY

FDA 510(k)
FDA Class 1 ·Microbiology

ARTHROCARE SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 5, 2024

UNKNOWN

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 23, 2013

7700

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 8, 2011

CAPSURE SP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

PINNACLE SECTOR II CUP 60MM

FDA Adverse Event
Injury ·. DEPUY ORTHOPAEDIC INC, 1818910·Product code KWA·May 25, 2018

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584742;

FDA Enforcement
Class II ·Ongoing·Beaver Visitec International, Inc.·September 4, 2024

VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC and bioMerieux sa, France.

FDA Recall
Terminated ·bioMerieux Inc·Product code LON·January 15, 2004

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