12 results · 28ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113578·PRESET 600 MICRON KNIFE (BX/5)

PARI SINUS

FDA 510(k)
FDA Class 2 ·Anesthesiology

SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT

FDA 510(k)
FDA Class 2 ·Immunology

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 30, 2014

RIATA ST ACTIVE FIXATION

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013

LONG 45 ENDOCUTTER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 18, 2010

ENDOWRIST

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·June 5, 2021

UNKNOWN HIP ACETABULAR LINERS

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 25, 2019

Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

FDA Enforcement
Class II ·Ongoing·Beckman Coulter, Inc.·November 12, 2025

UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

FDA Enforcement
Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

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