976 results
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17ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Artificial Iris
FDA classification
FDA Class 3
·Artificial Iris
Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·May 21, 2025
Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·May 21, 2025
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP
FDA Enforcement
Class I
·Ongoing·Baxter Healthcare Corporation·October 30, 2024
Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code CBK·April 7, 2025
Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code CBK·April 7, 2025
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code CBK·September 12, 2024
IBT Scientific
FDA registration
IBT Scientific·5 products·🇺🇸 United States
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·November 27, 2019
Lunit INSIGHT DBT
FDA UDI
Lunit Inc.·08800076000148·
Lunit INSIGHT DBT
FDA UDI
Lunit Inc.·08800076000162·
Screw-ZioCera ABT
FDA UDI
HIOSSEN, INC.·00810019241192·
Lunit INSIGHT DBT
FDA UDI
Lunit Inc.·08800076000230·
Screw-ZioCera ABT
FDA UDI
HIOSSEN, INC.·00810019241208·
NORDENT MANUFACTURING INC
FDA UDI
NORDENT MANUFACTURING INC·00840018636545·COMPOSITE INST PFI39AT-2BT DL
COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX
FDA 510(k)
FDA Class 2
·Anesthesiology
GlutarTest 1
FDA UDI
Ibt Scientific LLC·G212GT23101·1 bottle of 100 test strips to test glutaraldehyde
WaterCheckCP
FDA UDI
Ibt Scientific LLC·G212CP20101·1 bottle of 100 test strips to test residual Ch...
WaterCheck2
FDA UDI
Ibt Scientific LLC·G212CM20201·1 bottle of 100 test strips to check residual c...
WaterCheckRC
FDA UDI
Ibt Scientific LLC·G212RC22101·1 bottle has 100 test strips for testing residu...