14 results
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19ms
·
Sources: EU EUDAMED, US FDA
THE PORTABLE ORDERLY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TrueCal™ 35% Calcium Hydroxide Paste 4pk
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172010689·Calcium Hydroxide Suspension
Lacrimal Probe
FDA UDI
KATENA PRODUCTS, INC.·00841668108864·PIGTAIL PROBE WITH SUTURE HOLES
EXCELARREST FOAM
FDA 510(k)
FDA Unclassified
·Unknown
HEART SENTINEL
FDA 510(k)
FDA Class 2
·Cardiovascular
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·February 27, 2012
Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00
FDA Recall
Terminated
·Reckitt Benckiser LLC·Product code MOL·December 19, 2018
Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00
FDA Enforcement
Class II
·Terminated·Reckitt Benckiser LLC·March 20, 2019
CURRENT ACCEL DR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 13, 2014
UNK DEPUY PATELLA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·October 14, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·December 13, 2012
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·August 15, 2012
Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484
FDA Enforcement
Class II
·Terminated·Ortho Organizers, Inc.·July 8, 2020
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024