24 results
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20ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE M2-PE MICROKERATOME BLADES
FDA 510(k)
FDA Class 1
·Ophthalmic
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756001717·Cervical Collar
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004011·PowerChem Neoprene Exam Gloves, Extra Small
Leksell Gamma Knife Icon
FDA UDI
Elekta Instrument AB·07340048306584·QA+ TOOL
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0104010·Caddie Lid, Trials
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0104010·Caddie Lid, Cages, Universal
Kaliec Special
FDA UDI
Kalitec Direct LLC·B073DRK0300010·Probe, 1.75" Egg, Steffee Long Str Imp Crimson
VAPOTHERM, MODEL 2000I
FDA 510(k)
FDA Class 2
·Anesthesiology
TRI-PLEX ADAPTER
FDA 510(k)
FDA Class 2
·Anesthesiology
BOOMERANG PEEK FUSION DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·January 14, 2011
TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE GH
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·June 5, 2018
PS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 10-12 GH TOP
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·June 5, 2018
TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE GH
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·June 5, 2018
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 2, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·March 9, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·April 16, 2008
PS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 10-12 GH TOP
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·June 5, 2018
BASE SYSTEM, ILLUMENA
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM·Product code DXT·September 16, 2025
Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. Model Number 8C290 (Reorder No. 21-0304-01) Speciality Administration Set. Sterile, non-pyrogenic. Length 105 inch/267 cm, 25 ml priming volume, 20 drops/ml and 0 Injection sites, PVC cassette, non-PVC lined tubing, non-PVC drip chamber. Manufactured for Deltec SIMS Deltec, Inc., St. Paul, MN 55112 U.S.A. sims Smiths Industries Medical Systems.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FPA·December 8, 2005
Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Specialty Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 0 injection sites, PVC Cassette, non-PVC lined tubing, non-PVC drip chamber. Model Number I8C290 (Reorder No. 21-0317-25) for product distributed Internationally. Model Number 8C290 (Reorder No. 21-0304-01) for product distributed within the United States.
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004