11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERTICALE® Posterior Spinal Fixation System/VERTICALE® System
FDA 510(k)
FDA Class 2
·Orthopedic
PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204
FDA 510(k)
FDA Class 2
·Orthopedic
ISA CO2
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·December 30, 2022
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
RUSCH REINFORCED ENDOTRACHEAL TUBE, 8.0MM
FDA Adverse Event
Malfunction
·WILLY RUESCH GMBH·Product code BTR·June 29, 2011
PERCUFLEX URETERAL STENT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 17, 2008
BD SYRINGE 5ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 1, 2024
EVEREST ® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·STRYKER-SPINE·Product code LXH·September 9, 2019
Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·July 24, 2019
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