19 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI
FDA 510(k)
FDA Class 2
·Immunology
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20320351·BioTorque wires Straight-Arch-F. max. .014"x.025"
BENCO
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975015181·Adult Mouth Prop Black Box of 2
ihcDirect® Chromogranin A Ab, 15mL
FDA UDI
NOVODIAX, INC.·00850000596696·Clone R1004
ihcDirect® Chromogranin A Ab, 5mL
FDA UDI
NOVODIAX, INC.·00850000596689·Clone R1004
MASTERCARE AB
FDA registration
MASTERCARE AB·1 product·🇸🇪 Sweden
ihcDirect® E-Cadherin Ab Conjugate 15mL
FDA UDI
NOVODIAX, INC.·00850030934888·Clone R1005
ihcDirect® Chromogranin A Ab Conjugate 15mL
FDA UDI
NOVODIAX, INC.·00850030934567·Clone R1004
ihcDirect® Chromogranin A Ab Conjugate 5mL
FDA UDI
NOVODIAX, INC.·00850030934550·Clone R1004
SYSTEM FOR SOFT TISSUE GRAFT - STERILE PRODUCTS
FDA Adverse Event
Malfunction
·S.B.M. SAS·Product code MBI·June 2, 2025
BRAUN PRECISION SENSOR PRO, MODEL BP 2590
FDA 510(k)
FDA Class 2
·Cardiovascular
OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB
FDA 510(k)
FDA Class 2
·Dental
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 6, 2013
SURGICAL STAINLESS STEEL SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC. SAN LORENZO·Product code GAQ·March 28, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 21, 2008
MIDLINE CATHETERIZATION KIT: 4 FR X 8"
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code LJS·April 18, 2016
PICC SET: 4 FR X 19-5/8" (50 CM)
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code LJS·April 28, 2016
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024