18 results
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27ms
·
Sources: EU EUDAMED, US FDA
UMBILICAL CORD BLOOD SAMPLING KIT
FDA 510(k)
FDA Class 1
·Anesthesiology
ReLine
FDA UDI
Nuvasive, Inc.·00195377068149·RELINE C Conn,3.5-4/4.5-5mm Clsd In-Line
Tibial Spacer
FDA UDI
ADLER ORTHO SPA·08052693620524·2 mm LB TIBIAL SPACER
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746094927·DB BRACKET MASTER SERIES MAX 1ST/2ND BICUSPID 5...
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989022599·PEERLESS 0DEG SGL FM 0TRQX018 LR/UL
LEONE SPA
FDA UDI
LEONE SPA·08033707065654·INTRAORAL ELASTICS 2,5 oz 1/4" red
MEDLINE PVC URETHRAL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HARDY DISK, PENICILLIN, 10 UNITS
FDA 510(k)
FDA Class 2
·Microbiology
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 23, 2019
DBB-06 HEMODIALYSIS DELIVERY SYSTEM
FDA Adverse Event
Injury
·NIKKISO CO.,LTD·Product code KDI·December 10, 2020
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 19, 2017
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 14, 2017
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 2, 2017
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·October 6, 2017
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·May 6, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 7, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 16, 2010
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013