13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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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