20 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.

IRRIGATION OR INFUSION PUMP K PUMP

FDA 510(k)
FDA Class 2 ·General Hospital

MODEL SE-1 EYEGLASS HEARING AID

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

SCISSORS: THOREK, JORGENSEN, FINOCHIETTO

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

CONSULT HCG TEST

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2025

CATGUT CHROMIC 2/0 (3.5) 100M

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL SA·Product code GAL·November 27, 2018

CATGUT CHROMIC 3 (7) 50M

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL SA·Product code GAL·November 20, 2018

PINNACLE 100 HA ACET CUP 58MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·March 6, 2013

SUMMIT POR TAPER SZ4 HI OFF

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 8, 2014

SPRINT QUATTRO

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011

CATGUT PLAIN 3/0 (3) 100M

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAL·May 28, 2020

CATGUT PLAIN 1 (5) 75M

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAL·July 20, 2020

CATGUT PLAIN 1 (5) 75M

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAL·February 10, 2021

CATGUT CHROMIC 2 (6) 50M

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAL·February 25, 2021

ACIST

FDA Adverse Event
Malfunction ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·April 20, 2007

MEDIUM CHROM CAT 3/0 (3) 100M BAYER EE

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAL·February 17, 2020

CATGUT PLAIN 6 (10) 25M D2

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAL·December 31, 2019

CATGUT PLAIN 5 (9) 25M

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAL·July 16, 2019

CATGUT PLAIN 5 (9) 25M

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAL·October 29, 2019

CATGUT PLAIN 5 (9) 25M

FDA Adverse Event
Malfunction ·B.BRAUN SURGICAL SA·Product code GAL·December 31, 2019

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024