201 results · 7ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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