27 results · 24ms · Sources: EU EUDAMED, 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