49 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STIMLAB
FDA 510(k)
FDA Class 2
·Cardiovascular
ODYSSEY®
FDA UDI
Microport Orthopedics Inc.·M684K00722001·
LEONE SPA
FDA UDI
LEONE SPA·08033707000822·SOLDERABLE DOUBLE BITE S/STEEL
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702480603·ELVAREX 1/THIGH HIGH/SLANT-OPEN TOE/DOTED SIL. ...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702923827·ELVAREX 4/KNEE HIGH/SLANT-CLOSED TOE/DOTTED 5 ...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702545838·Elvarex Forte 3/Thigh High/Slant-Open Toe-Eleph...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07310K0122000·Assembly, Tab Breaker, Extended Tab
CAPELLA
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
1.5T INFINITY TWINSPEED MR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN
FDA Adverse Event
Malfunction
·COOK, INC.·Product code DTK·August 21, 2014
UNK
FDA Adverse Event
Injury
·COOK, INC.·Product code DTK·August 20, 2014
UNKNOWN
FDA Adverse Event
Injury
·COOK INC·Product code DTK·August 20, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013
ULTRAPRO HERNIA PLUG
FDA Adverse Event
Injury
·ETHICON·Product code FTL·April 28, 2011
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·February 8, 2023
GUNTHER TULIP VENA CAVA FILTER SET
FDA Adverse Event
Injury
·COOK INC·Product code DTK·April 3, 2026
GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DTK·September 12, 2017
Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.
FDA Enforcement
Class III
·Terminated·Viscot Medical LLC·April 10, 2013
NEEDLE FILTER BLUNT FILL 18X1-1/2
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·February 28, 2020