13 results · 28ms · 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.

Wet Flavored Personal Lubricants

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

Clamp, Transplantation, acc. Potts 27cm jaw 70x71mm

FDA UDI
Geister Medizintechnik GmbH·04057034059586·Clamp, Transplantation, acc. Potts 27cm j...

MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

ADVIA CENTAUR TROPONIN ULTRA ASSAY

FDA Adverse Event
Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·November 4, 2008

POWER PRO AMBULANCE COT

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code INK·July 21, 2011

LIBERTY CYCLER SET, SINGLE CONN/EXT. DL

FDA Adverse Event
Malfunction ·REYNOSA MANUFACTURING·Product code FKX·July 9, 2013

ARCOS 17X150MM SPL TPR DIST

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024

ARCOS CON SZ C STD 60MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 12, 2024

MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·April 20, 2023

Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

FDA Enforcement
Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·February 14, 2024

Model Number L111, ESSENTIO DR SL MRI Pacemaker

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

Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bone Screw AM-0030-S 30.0mm Acutrak¿ 4/5 Bone Screw AM-0035-S 35.0mm Acutrak¿ 4/5 Bone Screw AM-0040-S 40.0mm Acutrak¿ 4/5 Bone Screw AM-0045-S 45.0mm Acutrak¿ 4/5 Bone Screw AM-0050-S 50.0mm Acutrak¿ 4/5 Bone Screw AP-67100-S 100mm Acutrak¿ 6/7 Fixation Screw AP-67105-S 105mm Acutrak¿ 6/7 Fixation Screw AP-67110-S 110mm Acutrak¿ 6/7 Fixation Screw AP-67115-S 115mm Acutrak¿ 6/7 Fixation Screw AP-67120-S 120mm Acutrak¿ 6/7 Fixation Screw AP-6740-S 40mm Acutrak¿ 6/7 Fixation Screw AP-6745-S 45mm Acutrak¿ 6/7 Fixation Screw AP-6750-S 50mm Acutrak¿ 6/7 Fixation Screw AP-6755-S 55mm Acutrak¿ 6/7 Fixation Screw AP-6760-S 60mm Acutrak¿ 6/7 Fixation Screw AP-6765-S 65mm Acutrak¿ 6/7 Fixation Screw AP-6770-S 70mm Acutrak¿ 6/7 Fixation Screw AP-6775-S 75mm Acutrak¿ 6/7 Fixation Screw AP-6780-S 80mm Acutrak¿ 6/7 Fixation Screw AP-6785-S 85mm Acutrak¿ 6/7 Fixation Screw AP-6790-S 90mm Acutrak¿ 6/7 Fixation Screw AP-6795-S 95mm Acutrak¿ 6/7 Fixation Screw ATF-140-S 14.0mm Acutrak¿ Fusion Device ATF-160-S 16.0mm Acutrak¿ Fusion Device ATF-180-S 18.0mm Acutrak¿ Fusion Device ATF-200-S 20.0mm Acutrak¿ Fusion Device ATF-220-S 22.0mm Acutrak¿ Fusion Device ATF-240-S 24.0mm Acutrak¿ Fusion Device ATF-270-S 27.0mm Acutrak¿ Fusion Device ATF-320-S 32.0mm Acutrak¿ Fusion Device ATF-370-S 37.0mm Acutrak¿ Fusion Device ATM-100-S 10.0mm Mini Acutrak¿ Fixation Screw ATM-120-S 12.0mm Mini Acutrak¿ Fixation Screw ATM-140-S 14.0mm Mini Acutrak¿ Fixation Screw ATM-160-S 16.0mm Mini Acutrak¿ Fixation Screw ATM-180-S 18.0mm Mini Acutrak¿ Fixation Screw ATM-200-S 20.0mm Mini Acutrak¿ Fixation Screw ATM-220-S 22.0mm Mini Acutrak¿ Fixation Screw ATM-240-S 24.0mm Mini Acutrak¿ Fixation Screw ATM-260-S 26.0mm Mini Acutrak¿ Fixation Screw

FDA Enforcement
Class II ·Ongoing·Acumed LLC·January 4, 2023