437 results
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16ms
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Sources: EU EUDAMED, US FDA
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Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
FDA 510(k)
FDA Class 1
·Microbiology
New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)
FDA 510(k)
FDA Class 2
·Dental
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN
FDA 510(k)
FDA Class 2
·Microbiology
NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN
FDA 510(k)
FDA Class 2
·Microbiology
BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1
FDA 510(k)
FDA Class 2
·Orthopedic
HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN
FDA 510(k)
FDA Class 2
·Microbiology
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN
FDA 510(k)
FDA Class 2
·Microbiology
BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE
FDA 510(k)
FDA Class 2
·Hematology
RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
FDA 510(k)
FDA Class 2
·Radiology
ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V
FDA 510(k)
FDA Class 2
·Dental
SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS:
FDA 510(k)
FDA Class 2
·General, Plastic Surgery