24 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
FDA 510(k)
FDA Class 2
·General Hospital
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885380077395·1.1mm Threaded Guide Wire 150mm
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169601413·SPACER 2111150 OLIF25 20MM 6 DEG 8X50
BiPAP A30
FDA UDI
Respironics, Inc.·00606959039360·BiPAP A30-S Silver Series Ventilator
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK111151·DD tempMED are pre-colored dental milling blank...
SAV
FDA UDI
Diversified Products, Inc.·00842894133835·
Clear Readers
FDA UDI
Diversified Products, Inc.·00842894124123·
Clear Readers
FDA UDI
Diversified Products, Inc.·00842894113769·
DRIDAU OPIATE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PICC WAND PEELABLE SAFETY INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
LONG NAIL KIT R2.0, TI, RIGHT GAMMA3 Ø11X380MM X 125°
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS-KIEL·Product code HSB·April 12, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·September 23, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 2, 2011
BIPAP A30-S SILVER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·September 25, 2024
SYRINGE 100ML CATH TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·October 24, 2023
LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037
FDA Recall
Terminated
·Lifescan Inc·Product code CGA·November 17, 2003
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code MNS·March 26, 2024
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·May 29, 2024
Artis Q.zen ceiling, Model Number 10848354
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022