23 results · 21ms · Sources: EU EUDAMED, US FDA

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IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HHM

FDA UDI
Oticon A/S·05707131269034·H110, DESIGNRITE 10 WL CBE HHM

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017736·K-Wire, Double Ended, Trocar Point, Diameter Si...

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319720752·Gemini-Mixter Forceps 9" (22.5cm), delicate, fu...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197052276·Titan Halsted Mosquito Artery Forceps straig...

Integra-Ti

FDA UDI
BICON, LLC·00813110020819·4.0 x 8.0mm Integra-Ti Implant - 2.5mm Well

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197052269·Titan Hartmann Artery Forceps straig...

SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE

FDA 510(k)
FDA Class 2 ·Orthopedic

ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2025

STAT DL 9.5 FR. 40 CC. IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·September 16, 1998

STAT DL 9.5 FR. 40 CC. IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·September 16, 1998

STAT DL 9.5 FR. 34 CC. IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·July 23, 1998

STAT DL 9.5 FR. 40 CC. IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·September 16, 1998

ENDURANT II

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·May 31, 2013

ENCORE BALLOON CATHETER INFLATION DEVICE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - CORK·Product code MAV·June 27, 2011

PUMP MMT-522NAS PRDGM INS V2.2 SK EN

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 29, 2008

STAT DL 9.5 FR. 40 CC. IAB

FDA Adverse Event
Injury ·DATASCOPE CORP.·Product code DSP·August 18, 1998

ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU

FDA Enforcement
Class III ·Terminated·Ameditech Inc·December 30, 2015

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025