18 results · 21ms · Sources: EU EUDAMED, US FDA

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Powder Free Vinyl Patient Examination Gloves

FDA 510(k)
FDA Class 1 ·General Hospital

PMT® Halo Systems

FDA UDI
PMT CORPORATION·00650551111955·HALO, 1203-5 VEST MEDIUM, ACRYLIC LINER, 1211-1...

K. W. GRIFFEN CO.

FDA registration
K. W. GRIFFEN CO.·2 products·🇺🇸 United States

CORTAC®

FDA UDI
PMT CORPORATION·00650551068075·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 77 CO...

CORTAC®

FDA UDI
PMT CORPORATION·00650551092643·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 77 CO...

JUELL HARD CURE

FDA 510(k)
FDA Class 2 ·Dental

BCI ADVISOR VITAL SIGNS MONITOR (9200)

FDA 510(k)
FDA Class 2 ·Cardiovascular

630G INSULIN PUMP MMT-1715K 630G BLACK MG

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 28, 2018

SAFE-T-PRO

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·August 15, 2011

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·October 29, 2014

IN TOUCH ZU

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 8, 2013

PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBL·October 17, 2025

PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MEH·October 15, 2025

Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028.

FDA Enforcement
Class II ·Terminated·Philips North America Llc·December 29, 2021

bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2.3mm, 45o Bevel Up (h) REF 378224, 2.4mm, 45o Bevel Up (i) REF 378227, 2.75mm, 45o Bevel Up (j) REF 378228, 2.8mm, 45o Bevel Up (k) REF 378230, 3.0mm, 45o Bevel Up (l) REF 378232, 3.2mm, 45o Bevel Up (m) REF 378822, 2.2mm, 45o Double Bevel (n) REF 378824, 2.4mm, 45o Double Bevel (o) REF 378825, 2.5mm, 45o Double Bevel (p) REF 378826, 2.65mm, 45o Double Bevel (q) REF 378827, 2.75mm, 45o Double Bevel (r) REF 378828, 2.8mm, 45o Double Bevel (s) REF 378829, 2.85mm, 45o Double Bevel (t) REF 378830, 3.0mm, 45o Double Bevel (u) REF 378832, 3.2mm, 45o Double Bevel (v) REF 370145, 2.5mm, 45o Bevel Up (w) REF 370146, 2.6mm, 45o Bevel Up (x) REF 373025, kojo, 2.5mm, 45o Bevel Up (y) REF 373032, kojo, 3.2mm, 45o Bevel Up Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

FDA Enforcement
Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 3, 2026

Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper FD20 OR Table, Model Number: 722035. 7. Allura Xper FD20/20, Model Number: 722038 8. Allura Xper FD20/20 OR Table, Model Number: 722039. 9. Allura Xper FD20/15, Model Number: 722058. 10. Allura Xper FD20/15 OR Table, Model Number: 722059.

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·August 6, 2025