19 results · 27ms · Sources: EU EUDAMED, US FDA

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Oculus-SA Lumbar Cage System

FDA 510(k)
FDA Class 2 ·Orthopedic

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112793·BARRON VACUUM PUNCH 8.5MM

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112700·BARRON VACUUM PUNCH 6.0MM

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112786·BARRON VACUUM PUNCH 8.25MM

POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)

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

MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

UNKNOWN PROGRIP MESH PRODUCT

FDA Adverse Event
Injury ·SOFRADIM PRODUCTION SAS·Product code FTL·May 20, 2024

UNK - INSERTION INSTRUMENTS: TRAUMA

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·October 29, 2021

BD VENFLON INTRAVASCULAR CATHETER 20 G X 1

FDA Adverse Event
Injury ·BD·Product code FOZ·October 13, 2014

64 CONTACT PLATINUM CONFORMAL 4 SEP LEADS

FDA Adverse Event
Malfunction ·INTEGRA NEUROSCIENCES IMPLANTS S.A.·Product code GZL·October 16, 2008

HD 15 ULTRASOUND SYSTEM

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code IYO·June 28, 2013

PROXIMATE*55MM LINEAR CUTTER (EXACT CODE UNKNOWN)

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 8, 2025

SELECTSECURE MRI SURESCAN

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code NVN·April 14, 2022

MEDTRONIC TRANSCATHETER VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 2, 2021

DRIVESHAFT FOR SCREWDRIVER 90

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code DZI·October 28, 2021

UNK - CONSTRUCTS: HUMERAL NAIL

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code JDS·July 6, 2022

Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

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

Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018