fda-inspection-records

FDA inspections of firms in Sunnyvale, CA

52 firms in Sunnyvale were inspected by the FDA between fiscal years 2009 and 2026. Their most serious classification on file: 20 NAI, 28 VAI, 4 OAI. Main product types: Devices (44), Food/Cosmetics (6), Biologics (2).

FirmProduct typesInspectionsLatest inspection483 observations posted
Abbott Medical
FEI 2938836
Devices4Jan 22, 2016 · NAI—
Accuray Incorporated
FEI 1000123585
Devices4Aug 9, 2016 · NAI8
Accuray Incorporated
FEI 3005738050
Devices3Aug 9, 2016 · NAI—
Acta Products Corporation
FEI 3005641825
Food/Cosmetics1Mar 29, 2013 · NAI—
Algomedica, Inc.
FEI 3013488109
Devices2Mar 28, 2024 · VAI8
Allegria Inc
FEI 3002162207
Food/Cosmetics1Dec 9, 2010 · NAI—
Asante Solutions, Inc.
FEI 3009351200
Devices2Apr 10, 2014 · VAI2
Asthmatx, Inc.
FEI 3006139571
Devices2Aug 22, 2012 · VAI4
Avantec Vascular Corporation
FEI 3003524171
Devices5Mar 24, 2026 · NAI4
Avantis Medical
FEI 3006315255
Devices3Mar 10, 2016 · VAI8
BioCardia, Inc.
FEI 3003610571
Devices4Apr 10, 2023 · NAI2
Cepheid
FEI 3004530258
Devices5Aug 9, 2017 · NAI10
Ceribell Inc.
FEI 3013671918
Devices3Nov 6, 2024 · NAI—
Curatia Medical Co
FEI 3008361782
Devices2Dec 4, 2023 · NAI—
D.Sign Dental Lab Inc.
FEI 3005940438
Devices1Dec 21, 2017 · NAI—
Dongsheng Foods USA, Inc.
FEI 3004928388
Food/Cosmetics1Sep 27, 2018 · NAI—
EBR SYSTEMS INC
FEI 3013596742
Devices1Jan 17, 2025 · NAI—
Elekta, Inc.
FEI 1000123805
Devices3Aug 26, 2015 · VAI4
Embolx, Inc.
FEI 3011660785
Devices2Jan 19, 2023 · VAI6
Figure 8 Surgical, Inc
FEI 3009133648
Devices1Jul 25, 2014 · VAI3
Flowcardia Inc., A Subsidiary of C.R. Bard, Inc.
FEI 3005007189
Devices2Aug 20, 2012 · NAI1
Focal Therapeutics, Inc
FEI 3009718212
Devices2Jan 26, 2018 · NAI—
Greet Well Inc.
FEI 2000030206
Food/Cosmetics7May 9, 2025 · VAI6
HealthAid America
FEI 3004520617
Food/Cosmetics1Jun 14, 2022 · VAI1
Hologic, Inc.
FEI 3001632635
Devices2May 24, 2013 · NAI3
iHealth Labs, Inc.
FEI 3008787503
Devices2May 8, 2024 · VAI—
INFLAMMATIX INC
FEI 3022977716
Devices1Apr 30, 2026 · VAI1
Intraop Medical Corporation
FEI 3001874253
Devices2May 25, 2017 · NAI10
Intuitive Surgical Inc.
FEI 3007531906
Devices2May 7, 2019 · NAI—
Intuitive Surgical, Inc.
FEI 3001675293
Devices10Nov 5, 2025 · OAI26
Linatech, Llc
FEI 3007037519
Devices2Sep 29, 2021 · VAI17
Lucile Salter Packard Children's Hospital Stanford Medicine Fertility and Reproductive Health
FEI 3003971418
Biologics6Apr 18, 2025 · NAI1
Madras Groceries
FEI 3010140870
Food/Cosmetics2Jan 5, 2022 · OAI2
Meddev Corp
FEI 2921577
Devices3Mar 12, 2025 · VAI7
Medtronic Vascular, Inc.
FEI 3008493192
Devices2Apr 19, 2017 · NAI—
Medtronic, Inc.
FEI 3015180993
Devices1Oct 8, 2020 · NAI—
NIMBLEHEART, INC
FEI 3021219789
Devices1Jun 27, 2025 · VAI9
PANTHER ORTHOPEDICS, INC.
FEI 3015145450
Devices1Aug 23, 2022 · NAI—
Paracor Medical, Inc
FEI 3005423435
Devices1Feb 20, 2009 · NAI—
Peter Charles Klatsky, M.D., Inc.
FEI 3017149947
Biologics2May 20, 2025 · NAI—
Polymer Technology Systems, Inc.
FEI 3002940409
Devices3Jun 21, 2017 · NAI—
Prime Herbs Corporation
FEI 3004714242
Devices4Apr 1, 2016 · VAI45
Promega Biosystems Sunnyvale, Inc.
FEI 3006795852
Devices1Oct 8, 2010 · VAI2
Relievant Medsystems, Inc.
FEI 3006789852
Devices3Jun 23, 2022 · NAI—
Samax Precision Inc.
FEI 3007111496
Devices2Mar 26, 2025 · NAI—
Silk Road Medical Inc
FEI 3007215228
Devices6Oct 18, 2023 · NAI2
Simplify Medical, Inc.
FEI 3012070713
Devices1Mar 10, 2020 · NAI—
Spinal Kinetics Inc
FEI 3004987282
Devices3Mar 9, 2018 · NAI—
Spiracur, Inc.
FEI 3008087410
Devices1Jul 23, 2014 · NAI—
U-systems Inc
FEI 3003248267
Devices4Mar 31, 2017 · NAI8
United Bioresearch Inc
FEI 2937601
Devices1Jul 19, 2011 · VAI8
W. L. Gore & Associates, Inc.
FEI 3000719179
Devices3Aug 21, 2015 · VAI4

Alphabetical order — this site ranks no firm. Inspections from fiscal year 2009 to 2026; the classification is the FDA's (NAI no action indicated, VAI voluntary action indicated, OAI official action indicated). Select a firm for every inspection, the posted Form 483 observations and any compliance action. How to read this.