14 results · 21ms · 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.

MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215

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

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033614·Baltic Denture System BDLoad BDLoad Mw6 PLSEbi...

Humelock Reversed Shoulder

FDA UDI
FX SOLUTIONS·03701037304679·TRIAL HUMELOCK REVERSED STEM Ø36/14

TROJAN CRYSTAL CLEAR LIQUID

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

LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM

FDA Adverse Event
Other ·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005

SIMPLEX P FULL DOSE 1 PACK

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LOD·April 3, 2013

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code LTI·February 11, 2011

SYNCHROMED EL

FDA Adverse Event
Injury ·RICE CREEK MFG·Product code LKK·April 24, 2008

ROD, FIXATION, INTRAMEDULLARY

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code HSB·January 22, 2017

UNKNOWN PFM-R DISTAL STEM

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code JDI·March 13, 2018

Instructions For Use document of the GPS Trackers.

FDA Enforcement
Class II ·Terminated·Blue Ortho·November 4, 2020

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024