11 results · 20ms · Sources: EU EUDAMED, US FDA

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PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

General Instruments

FDA UDI
ALPHATEC SPINE, INC.·00840180502976·Distractor Tip, Lamina, Long, No Offset, Right

O-PERM 30

FDA 510(k)
FDA Class 2 ·Ophthalmic

CLEARFIL CORE NEW BOND

FDA 510(k)
FDA Class 2 ·Dental

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 27, 2025

MERSILENE POLYESTER FIBER MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·April 23, 2013

RX ACCULINK CAROTID STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code NIM·April 29, 2011

INSYNC SENTRY

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NIK·July 10, 2008

ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc.·Product code JWM·February 10, 2003

KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

FDA 510(k)
FDA Class 2 ·Neurology

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