13 results · 20ms · 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.

BHA100 Series Braun Clear Hearing Aid

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

meijer

FDA UDI
MEIJER, INC.·00713733521703·First Aid Kit, First Aid Essentials, 70 items +...

Richard-Allan® Needle 1/2 Circle Taper

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00840113216888·Intent to be used with suture material for tiss...

Bernafon

FDA UDI
Bernafon AG·05711584114681·CO1 MNR T, 2.4G NFM SABE DEMO CAPTO 1 GPL

ABSORBENT PAPER POINTS

FDA UDI
DiaDent Group International·08806383515078·"An absorbent paper points is an endodontic pap...

Spartan Calcar Planer Blade Wrench

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215115821·

CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25

FDA 510(k)
FDA Class 2 ·Cardiovascular

DESARA MESH

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

HAKIM VENTRICULAR & PERITONEAL CATHETER WITH BACTISEAL

FDA Adverse Event
Injury ·CODMAN & SHURTLEFF, INC./MEDOS S.A.·Product code JXG·October 24, 2008

OCTRODE PERCUTANEOUS LEAD, 60 CM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 11, 2011

COGNIS

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 9, 2013

MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds

FDA Enforcement
Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026

18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017