15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ePatch
FDA 510(k)
FDA Class 2
·Cardiovascular
Jaeger
FDA UDI
Jaeger Medical GmbH·04250892900353·MasterScreen Pneumo
Jaeger
FDA UDI
Jaeger Medical GmbH·04250892905273·MasterScreen Pneumo
NC Coping for screw-retained abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600303558·
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100752·FLIERINGA FIXATION RING 14MM
NUVASIVE LONG LATERAL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ARGEN PEARL BRAND ZIRCONIA
FDA 510(k)
FDA Class 2
·Dental
GREENLIGHT HPS LASER SYSTEM
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·August 15, 2011
VC10 PUMP, 115V
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code HHK·January 2, 2025
LATITUDE ELBOW ANATOMIC HUMERAL SPOOL SZ PETIT+ SIDE DROIT
FDA Adverse Event
Injury
·TORNIER INC·Product code JDB·September 20, 2024
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
CELLUGEL
FDA Adverse Event
Malfunction
·ALCON - BELGIUM / S.A. ALCON - COUVREUR N.V.·Product code LZP·June 30, 2011
RADIAL JAW 3 SINGLE - USE BIOPSY FORCEPS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FCL·September 17, 2008
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020