16 results · 19ms · 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.

PRISMASATE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033503645·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033503621·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033503638·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033503614·

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0134080·Trial, TLIF, 27L OB STR 7Deg, 8mm

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033503652·

DESIGN OPTICS

FDA UDI
FGX INTERNATIONAL INC.·00193033503607·

DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

HORIZONS INTERNATIONAL VARICES INJECTION NEEDLES

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

UNKNOWN DEPUY ASR FEMORAL HEAD

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KXA·March 20, 2013

TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 10, 2011

SPRINT QUATTRO

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2008

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

Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022