18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Non Absorbable Surgical Nylon Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bernafon
FDA UDI
Bernafon AG·05711584115459·CO1 MNR T, 2.4G NFM SABE/MSIL CAPTO 1 GPL
Richard-Allan® Needle 1/2 Circle Taper
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00840113217007·Intent to be used with suture material for tiss...
VERIDIAN
FDA UDI
VERIDIAN HEALTHCARE LLC·00845717000413·ProKit Aneroid Sphygmomanometer With Sprague Sc...
BioHorizons
FDA UDI
BIOHORIZONS IMPLANT SYSTEMS, INC·00847236002121·External 6.0mm x 3mm Flared Healing Abutment
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383515016·"An absorbent paper points is an endodontic pap...
Monoblock Stem Impactor
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215109004·
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 18, 2022
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 18, 2022
BINAXNOW COVID-19 AG SELF TEST 2CT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 18, 2022
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·October 24, 2008
UNKNOWN ZIMMER ACETABULAR LINER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWB·August 11, 2011
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 9, 2013
MICRA
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code PNJ·January 22, 2025
bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
FDA Enforcement
Class II
·Terminated·Beaver-Visitec International Inc.·February 7, 2018
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