14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Electrosurgical accessory
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DG Gel 8 Anti-IgG (Rabbit)
FDA UDI
DIAGNOSTIC GRIFOLS SA·08437014205060·The DG Gel 8 Anti-IgG (Rabbit) card is for the ...
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551039945·BUSHING FOR DRIVER FOR ROSA ROBOT, FOR 2.1MM DRILL
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306824197·McGivney Hemorrhoid Grasping Forceps
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197125819·Muck periosteal knife
13.0 c...
LIFESTYLES ZERO LUBRICATED LATEX CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEARTSTART SLA BATTERY
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DQA·August 8, 2014
OCTRODE PERCUTANEOUS LEAD, 60 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 9, 2011
ENERGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 8, 2013
SEARCH-CYTE TCS 0.8%
FDA Adverse Event
Malfunction
·MEDION GRIFOLS DIAGNOSTICS AG·Product code QHT·September 5, 2025
Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015