14 results · 26ms · Sources: EU EUDAMED, US FDA

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Fixone hybrid knotless anchor

FDA 510(k)
FDA Class 2 ·Orthopedic

Responsive Respiratory

FDA UDI
RESPONSIVE RESPIRATORY, INC.·00851440007780·Pediatric Oxygen Mask, Medium Concentration

Needle aspiration and injection

FDA UDI
KATENA PRODUCTS, INC.·00841668113622·PERIBULBAR NEEDLE 25GA 32MM

EVER-MORE POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS

FDA 510(k)
FDA Class 3 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 31, 2025

AUTOCAT2 WAVE

FDA Adverse Event
Malfunction ·ARROW INTL., INC.·Product code DSP·October 17, 2008

CAPSURE Z

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

INTERSTIM II

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 3, 2013

VASSALLO GT

FDA Adverse Event
Injury ·FILMECC CO., LTD.·Product code DQX·October 3, 2024

ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

FDA Enforcement
Class I ·Terminated·Oscor, Inc.·July 19, 2017

ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

FDA Enforcement
Class I ·Terminated·Oscor, Inc.·July 19, 2017

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

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025