27 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950008797·ACE EXTENSION TUBE 12" STER 2CC VOLUME L/F 100/CA
PremEco Line Prothetik Color System
FDA UDI
Merz Dental GmbH·D7091030012·PremEco Line Prothetik Color System Refill: col...
SILVERVENT
FDA UDI
Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948037340·SILVERVENT MULTI 1 ICU + 1 ICF-O2, SIZE 12
SILVERVENT
FDA UDI
Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948110333·SILVERVENT Jatho 1 IC, SIZE 12
FDA Pre-Market Approval
IMAGECHECKER CT CAD SOFTWARE SYSTEM
General Instrument
FDA UDI
ORTHOPEDIATRICS CORP.·00841132126608·2.5 Holding Sleeve
Citrelock ACL 10mm Sizing Tube
FDA UDI
Acuitive Technologies, Inc.·00810027270993·
Intelliguides
FDA UDI
Mios Marketing, LLC·G2711020300120·Lateral Midfoot Charcot Guide, 30mm x 12mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710820300120·Zadik Calcaneal Guide, 30mm x 12°
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710620300120·Quad Channel Met-Traverse, 30mm x 12mm
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RAICHEM PHOSPORUS REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
COMPLETE DOUBLE MOIST
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code LPN·October 14, 2014
PLUM LS PRIM. 225 CM CLAVE PORT DISTA
FDA Adverse Event
Injury
·HOSPIRA COSTA RICA LTD.·Product code FPA·March 22, 2013
TI COLLAR WITH GROOVES
FDA Adverse Event
Injury
·SYNTHES USA·Product code MNH·April 2, 2013
ANCHOR FAST
FDA Adverse Event
Malfunction
·HOLLISTER INCORPORATED·Product code CBH·March 15, 2011
PROVEN REVISION KNEE
FDA Adverse Event
Injury
·STELKAST INC.·Product code JWH·April 14, 2008
BD EMERALD¿ 10ML SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·October 17, 2017
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024