9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)
FDA 510(k)
FDA Class 2
·General Hospital
NA
FDA UDI
Medos International Sàrl·10886705031771·Button Obturator Compatible with 1.9 mm Endosco...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112588·BARRON CORNEAL PUNCH 6.75MM
ST'RIM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 10, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014