13 results · 24ms · 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.

ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NexxZr™ T / D-100-25-NT-B300-SD

FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271112958·

ORTHO SUMMIT SAMPLE HANDLER

FDA Adverse Event
Malfunction ·HAMILTON BONADUZ AG·Product code JTC·August 18, 1999

POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

FDA 510(k)
FDA Class 1 ·General Hospital

GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000

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

TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC

FDA Adverse Event
Injury ·COOK INC·Product code LJS·December 3, 2015

AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·April 19, 2023

ALTRX +4 10D 32IDX50OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC./REG. #1818910·Product code LPH·May 29, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 16, 2011

ALARIS INFUSION SET

FDA Adverse Event
Injury ·CARDINAL HEALTH ALARIS PRODUCTS·Product code FPA·August 21, 2008

Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017

Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

cobas 6000 analyzer series Operators Manual Roche cobas; 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