19 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Ceribell Instant EEG Headband
FDA 510(k)
FDA Class 2
·Neurology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293449·
NA
FDA UDI
KEY SURGICAL, INC.·10849771049606·Steinmann Pins, Double trocar, .125-inch (3.2mm...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·14026704912411·
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484832·Steinmann pin w. double end trocarpoint _x000D_...
Steinmann pin w. double end trocarpoint 3.2mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM714590·Steinmann pin w. double end trocarpoint
3.2mm/...
KOMET Surgical Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613208175·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973837·
B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES
FDA 510(k)
FDA Class 2
·General Hospital
OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770
FDA 510(k)
FDA Class 2
·Orthopedic
INTERJECT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FCG·May 27, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·October 14, 2014
INTEGRITY RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MAF·June 30, 2011
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
GMK-HINGE FEMORAL COMPONENT SIZE 6 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·December 13, 2023
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021