10,000 results · 148ms · 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.

Rebound Ankle Brace

FDA registration
OSSUR H/F·1 product·🇮🇸 Iceland

IcePro Socket TT

FDA registration
OSSUR H/F·1 product·🇮🇸 Iceland

Rapid SARS-CoV-2 Antigen Test Card

FDA UDI
LUMIQUICK DIAGNOSTICS, INC.·00855636003716·The Rapid SARS-CoV-2 Antigen Test Card is a sin...

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EASYTRAK 3 IS-1 & LV-1 HEART FAILURE LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EASYTRAK 2 IS-1 CORONARY VENOUS BIPOLAR PACE/SENSE LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·EASYTRAK 3 IS-1 AND LV-1 HEART FAILURE LEADS

Activa Instrument

FDA UDI
Bioretec Oy·E302BIS27059·Double drill sleeve Ø2.0/2.7 mm, for 2.7mm screws

Activa Instrument

FDA UDI
Bioretec Oy·E302BIS20009·Drill bit Ø1.5 mm, for 2.0 mm screws, quick cou...

Lead Adaptor

FDA UDI
Oscor Inc.·00885672011222·Lead Adaptor

Activa Instrument

FDA UDI
Bioretec Oy·E302BIS45119·Tap Ø4.5 mm, for 4.5 mm screws up to length 45 mm

Activa Instrument

FDA UDI
Bioretec Oy·E302BIS90109·T-handle, quick coupling

Activa Instrument

FDA UDI
Bioretec Oy·E302BIS20059·Double drill sleeve Ø1.5/2.0 mm, for 2.0mm screws

BIS/BLV-13

FDA UDI
Oscor Inc.·00836559004752·

Activa Instrument

FDA UDI
Bioretec Oy·E302BIS35039·Holding sleeve, for 2.0/2.7/3.5mm screws

BLV/BIS-10

FDA UDI
Oscor Inc.·00836559006411·

Activa Instrument

FDA UDI
Bioretec Oy·E302BIS90329·HEX shaft, for 2.0/2.7/3.5 mm screws

Activa Instrument

FDA UDI
Bioretec Oy·E302BIS90209·Depth gauge, for 2.0/2.7/3.5 mm screws

B/IS-15

FDA UDI
Oscor Inc.·00836559002666·

Activa Instrument

FDA UDI
Bioretec Oy·E302BIS35049·Countersink, for 2.7/3.5 mm screws

Activa Instrument

FDA UDI
Bioretec Oy·E302BIS35019·Tap Ø3.5 mm, for 3.5 mm screws