2,678 results · 20ms · 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.

OT EQUATOR

FDA UDI
RHEIN 83 SRL·08059224205403·Set of devices intended to be incorporated into...

Instrument

FDA UDI
Stanmore Implants Worldwide Ltd·05060296236434·Base - Small Customs Tray

Instrument

FDA UDI
Stanmore Implants Worldwide Ltd·05060296236441·Insert - Small Customs Tray

ENDOPATH*PROBE PLUS II SHAFT

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 24, 2020

Phoenix Key Tie

FDA UDI
PHOENIX ORTHODONTICS INC·05060772894080·KEY TIE SMOKE PK1000

BD PRECISIONGLIDE¿ 27 G X 1/2" HYPODERMIC NEEDLES

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·February 1, 2023

200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance Module, 200998 Cable Assembly, Hybrid, UI Panel Subcomponents for the 203000 RIO STANDARD SYSTEM Manufactured by: MAKO Surgical, Corp. Fort Lauderdale, FL. All three cables are integral components and are not purchased separately. However, 200996-Cable Assembly is the only cable visible. This cable is labeled: 200996-REV-1, KSM 390634-1, SN 000001. 200997 and 200998 Cable Assembly are not visible . The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

FDA Recall
Terminated ·Mako Surgical Corporation·Product code HAW·July 17, 2009

System, Test, Combs, Automated

FDA classification
FDA Class 2 ·System, Test, Combs, Automated

CSM Implant

FDA registration
CSM Implant·3 products·🇰🇷 South Korea

GSM, LLC

FDA registration
GSM, LLC·1 product·🇺🇸 United States

DSM Biomedical, Inc.

FDA registration
DSM Biomedical, Inc.·29 products·🇺🇸 United States

DSM HOLDINGS CO., LTD

FDA registration
DSM HOLDINGS CO., LTD·1 product·🇰🇷 South Korea

CAP SYSTEM RAST ASM/RIA AND ASM/FEIA

FDA 510(k)
FDA Class 2 ·Immunology

PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5-

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

K-2SM SmartMatt

FDA UDI
KAP MEDICAL·00817012029376·Auto Immerssion, Alternating Pressure with On-D...

K-2SM SmartMatt

FDA UDI
KAP MEDICAL·00817012029345·Auto Immerssion, Alternating Pressure with On-D...

K-2SM SmartMatt

FDA UDI
KAP MEDICAL·00817012029369·Auto Immerssion, Alternating Pressure with On-D...

K-2SM SmartMatt

FDA UDI
KAP MEDICAL·00817012029307·Auto Immerssion, Alternating Pressure with On-D...

K-2SM SmartMatt

FDA UDI
KAP MEDICAL·00817012030563·Alternating Pressure, Auto Immersion, On-Demand...

K-2SM SmartMatt

FDA UDI
KAP MEDICAL·00817012029338·Auto Immerssion, Alternating Pressure with On-D...