8 results
10-Q
2024 Q1
GUTS
Fractyl Health Inc.
13 May 24
Quarterly report
4:06pm
to timely review and process our regulatory submissions and perform its audits.
A recall of our products, if approved, either voluntarily … impact on us.
The FDA and similar foreign governmental authorities have the authority to require the recall of commercialized medical devices
10-K
2023 FY
GUTS
Fractyl Health Inc.
1 Apr 24
Annual report
7:15am
. If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or request the recall … the public health or to provide additional safety and effectiveness data for the medical product;
the FDA’s recall authority, whereby it can ask
424B4
GUTS
Fractyl Health Inc.
2 Feb 24
Prospectus supplement with pricing info
4:18pm
regulatory submissions and perform its audits.
A recall of our products, if approved, either voluntarily or at the direction of the FDA or another … foreign governmental authorities have the authority to require the recall of commercialized medical devices in the event of material deficiencies
S-1/A
GUTS
Fractyl Health Inc.
29 Jan 24
IPO registration (amended)
6:09am
in the EU and EEA and the ability of the notified body to timely review and process our regulatory submissions and perform its audits.
A recall of our … the recall of commercialized medical devices in the event of material deficiencies or defects in design or manufacture or in the event that a product
S-1
GUTS
Fractyl Health Inc.
14 Dec 23
IPO registration
3:39pm
submissions and perform its audits.
A recall of our products, if approved, either voluntarily or at the direction of the FDA or another governmental authority … governmental authorities have the authority to require the recall of commercialized medical devices in the event of material deficiencies or defects in design
S-1
EX-10.1
lix3pev1r
14 Dec 23
IPO registration
3:39pm
DRS/A
c3bn dm1l
21 Sep 23
Draft registration statement (amended)
12:00am
DRS/A
raja2srej4dtnxf
22 Aug 23
Draft registration statement (amended)
12:00am
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