31 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPTIS Mobile System
FDA 510(k)
FDA Class 2
·Radiology
DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169502314·INTERBODY 2152120 SMALL - 12 DEG 20MM
Epredia
FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693063814·The blades and knifes consumables are for use w...
Portex
FDA UDI
ICU MEDICAL, INC.·00351688011391·
Boss Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515179622·Micro Disc Ret, self ret, 6", 120x20mm, left ho...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192244·Apex Revision Knee Reamer – ZIMMER SHORT FLUTES...
LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50
FDA 510(k)
FDA Class 2
·Radiology
NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202
FDA 510(k)
FDA Class 2
·Anesthesiology
CHIC
FDA UDI
Gc Orthodontics America Inc.·D78815212000201·CHIC MINI MBT 022/UR2 10T 8A
SunMed
FDA UDI
SUNMED, LLC·20889483041113·GUEDEL PVC SZ00 PINK 40mm P/50
CHIC
FDA UDI
Gc Orthodontics America Inc.·D78815212000101·CHIC MINI ROTH 022 UR2 8T 9A 0OF
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 13, 2020
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·January 6, 2003
BINAXNOW
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 14, 2021
TRULIANT TIB IMP PSC INSERT SZ 6, 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 11, 2024
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·May 24, 2013
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 15, 2015
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 27, 2016
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·October 7, 2010