14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)
FDA 510(k)
FDA Class 1
·General Hospital
Richard-Allan® Needle 1/2 Circle Taper
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00840113216802·Intent to be used with suture material for tiss...
Bernafon
FDA UDI
Bernafon AG·05711584114162·CZ9 B 105, 2.4G NFM MSIL/MAC CORAL 9 GPL
meijer
FDA UDI
MEIJER, INC.·00713733521659·All-In-One Adhesive Pad, all one size, Dressing...
VERIDIAN
FDA UDI
VERIDIAN HEALTHCARE LLC·00845717000468·ProKit Aneroid Sphygmomanometer With Sprague Sc...
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383515115·"An absorbent paper points is an endodontic pap...
IntelAir
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071131944·IntelAir, Tape Secured, with O2/CO2 Tubes, 26F ...
INTEGRITY(TM)
FDA 510(k)
FDA Class 2
·Radiology
REPROCSSED LINVATEC SHAVERS
FDA 510(k)
FDA Class 2
·Orthopedic
HAKIM VALVE, RIGHT ANGLE RES, UNITIZED SG
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC./MEDOS S.A.·Product code JXG·October 24, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·August 11, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2.3mm, 45o Bevel Up (h) REF 378224, 2.4mm, 45o Bevel Up (i) REF 378227, 2.75mm, 45o Bevel Up (j) REF 378228, 2.8mm, 45o Bevel Up (k) REF 378230, 3.0mm, 45o Bevel Up (l) REF 378232, 3.2mm, 45o Bevel Up (m) REF 378822, 2.2mm, 45o Double Bevel (n) REF 378824, 2.4mm, 45o Double Bevel (o) REF 378825, 2.5mm, 45o Double Bevel (p) REF 378826, 2.65mm, 45o Double Bevel (q) REF 378827, 2.75mm, 45o Double Bevel (r) REF 378828, 2.8mm, 45o Double Bevel (s) REF 378829, 2.85mm, 45o Double Bevel (t) REF 378830, 3.0mm, 45o Double Bevel (u) REF 378832, 3.2mm, 45o Double Bevel (v) REF 370145, 2.5mm, 45o Bevel Up (w) REF 370146, 2.6mm, 45o Bevel Up (x) REF 373025, kojo, 2.5mm, 45o Bevel Up (y) REF 373032, kojo, 3.2mm, 45o Bevel Up 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