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Syntec Scientific Corp.

FDA Regulatory Profile

Syntec Scientific Corp. has 0 FDA recalls, 5 inspections, 19 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Syntec Scientific Corp." and its spelling variants "Syntec Scientific", "Syntec Scientific Corporation".

Latest inspection: Mar 26, 2026 · NAI
Latest 510(k): Sep 17, 2021

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	19	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	5	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Syntec Scientific Corp.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	1	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	1	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

5 inspections from Jul 1, 2010 to Mar 26, 2026.

Date	Site	Product	Classification	FEI
Mar 26, 2026	Shenkang Hsiang, Changhua Hsien, Taiwan	Devices	No Action Indicated (NAI)	3003414678
May 5, 2023	Shenkang Hsiang, Changhua Hsien, Taiwan	Devices	No Action Indicated (NAI)	3003414678
Dec 13, 2018	Shenkang Hsiang, Changhua Hsien, Taiwan	Devices	Voluntary Action Indicated (VAI)	3003414678
Dec 18, 2014	Shenkang Hsiang, Changhua Hsien, Taiwan	Devices	Voluntary Action Indicated (VAI)	3003414678
Jul 1, 2010	Shenkang Hsiang, Changhua Hsien, Taiwan	Devices	Voluntary Action Indicated (VAI)	3003414678

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3003414678	Shenkang Hsiang, Changhua Hsien, Taiwan	5	Mar 26, 2026

Recent 510(k) clearances

19 510(k) clearances from Oct 5, 1998 to Sep 17, 2021.

K-Number	Device	Date
K202790	Syntec Orthodontic Mini Screw Extended System	Sep 17, 2021
K202935	Syntec Femoral Nail Extended System	Oct 28, 2020
K200933	Syntec Non-Sterile Steinmann Pins System	May 5, 2020
K191617	Syntec Tibial Nail System	Sep 3, 2019
K181296	Syntec Femoral Nail System	Apr 11, 2019
K161327	SYNTEC HUMERAL NAIL SYSTEM	Jun 8, 2017
K111189	SYNTEC DENTAL IMPLANT	Dec 20, 2012
K101971	SYNTEC OS SPINAL FIXATION SYSTEM	Mar 25, 2011
K092889	SYNTEC OSTEO-PLATE AND SCREW FIXATION	Jun 25, 2010
K090476	SYNTEC ORTHODONTIC MINI SCREW	Jun 18, 2009
K090839	MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS	Apr 24, 2009
K984602	SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM	Mar 5, 1999
K984364	SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820	Mar 2, 1999
K984543	SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870…	Mar 1, 1999
K983988	SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE	Jan 27, 1999
K983873	SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM	Dec 30, 1998
K983495	SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980…	Dec 16, 1998
K983757	SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR…	Dec 4, 1998
K983121	NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330…	Oct 5, 1998

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