13 results
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19ms
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Sources: EU EUDAMED, US FDA
REPLACABLE BATTERY HI-TEMP CAUTERY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813056707·NI-TEK DIMPLE ARCHWIRE .014/L PK10
4CIS SOLAR SPINE SYSTEM
FDA UDI
ALPHA AI CO.,LTD.·08806373532870·Rod connector, Domino
Greenwald Surgical Company, Inc.
FDA UDI
GRACE MANUFACTURING, INC.·10801334012304·McCrea Female Sound, Curved. 3/4-inch nominal b...
4CIS® Spinal System and 4CIS® Low Back System
FDA UDI
ALPHA AI CO.,LTD.·08800313887952·Rod Connector
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100140·Implant Tray, Cosmolock, Arcamed
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1100140·Implant Tray
INSTANT-VIEW METHADONE URINE DIP STRIP TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Creme de La Femme Feminine Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code FZP·November 12, 2007
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·October 23, 2012
FRESENIUS 2008K
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·April 25, 2014
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021