19 results · 20ms · Sources: EU EUDAMED, US FDA

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powder free nitrile examination glove - white, non-sterile

FDA 510(k)
FDA Class 1 ·General Hospital

Richard-Allan® Needle 1/2 Circle Reverse Cutting

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00840113215447·Intent to be used with suture material for tiss...

InSitu Hip System

FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127022432·Femoral Head, 28mm, +3.5mm, Biolox

GLOBAL ADVANTAGE

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295088189·GLOBAL ADVANTAGE FX HEAD GAUGE 44,48,52mm

GLOBAL ADVANTAGE

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295088165·GLOBAL ADVANTAGE HEAD GAUGE 40,56mm

GLOBAL ADVANTAGE

FDA UDI
DEPUY (IRELAND)·10603295088196·GLOBAL ADVANTAGE + IMPACTION BLOCK

PIPELINE TOTAL HIP SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MP3CF ELECTRIC WHEELCHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

BEBACK CROSSING CATHETER

FDA Adverse Event
Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·December 23, 2025

BEBACK CROSSING CATHETER

FDA Adverse Event
Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·November 21, 2025

BEBACK CROSSING CATHETER

FDA Adverse Event
Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·April 30, 2025

BEBACK CROSSING CATHETER

FDA Adverse Event
Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·March 6, 2025

HEMOCHRON JR PT CUVETTE

FDA Adverse Event
Malfunction ·ITC·Product code GFO·August 12, 2011

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014

UNKNOWN OPTEASE VENA CAVA FILTER

FDA Adverse Event
Malfunction ·CORDIS DE MEXICO·Product code DTK·July 9, 2013

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

18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

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

DRX Revolution Mobile X-Ray System

FDA Enforcement
Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023