201 results
·
7ms
·
Sources: EU EUDAMED, US FDA
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
FDA 510(k)
FDA Class 2
·Dental
Intermittent Catheter (Not Finalized)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ORTHODONTIC ACRYLIC (NOT FINALIZED)
FDA 510(k)
FDA Class 2
·Dental
Female IC (Not Finalized)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ORTHO-1(NOT FINALIZED)
FDA 510(k)
FDA Class 2
·Dental
Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
FDA 510(k)
FDA Class 2
·Dental
IV Sets not made with PVC
FDA 510(k)
FDA Class 2
·General Hospital
Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
All-Bond Universal w/BAC (not finalized)
FDA 510(k)
FDA Class 2
·Dental
COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Microscope, Automated, Image Analysis, Operator Intervention
FDA classification
FDA Class 2
·Microscope, Automated, Image Analysis, Operator Intervention
SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Hemodialysis Tray (Not A Start/Stop Kit)
FDA classification
FDA Class 2
·Hemodialysis Tray (Not A Start/Stop Kit)
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
FDA classification
FDA Class 2
·Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
FDA classification
FDA Class 2
·Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
FDA classification
FDA Class 2
·Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
FDA classification
FDA Class 2
·Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Rongeur, Cystoscopic, Hot
FDA classification
FDA Class 2
·Rongeur, Cystoscopic, Hot