Product code NLQ ยท Class U
Single-Use Reprocessed Ultrasonic Surgical Instruments
0510(k)s in 12 months (27 all time)
1recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in NLQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Sustainability Solutions | 7 | 3 |
| Sterilmed, Inc. | 8 | 1 |
| Ascent Healthcare Solutions | 2 | 0 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 2 |
| Surgical Instrument Service and Savings, Inc. | 1 | 1 |
| Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 2 | 0 |
| Vanguard Medical Concepts, Inc. | 2 | 0 |
| Alliance Medical Corp. | 1 | 0 |
| Medisiss | 1 | 0 |
| Surgical Instrument Services and Savings, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2025 | Stryker Sustainability Solutions HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length
REF: HAR9F,
Reprocessed Device for Single Use, STERILEEO, RX ONLY Open, Classified |
NLQ | K170456 |
| Sep 10, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R. Open, Classified |
NLQ | K193563 |
| Oct 16, 2023 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument. Open, Classified |
NLQ | K193563 |
| Jan 19, 2021 | Stryker Sustainability Solutions Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bl Open, Classified |
NLQ | K161693 |
| May 8, 2018 | Stryker Sustainability Solutions Reprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36
Product Usage:
The Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis are i Terminated |
NLQ | K161693 |
| Jul 1, 2013 | Surgical Instrument Service And Savings, Inc. Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762
Unclassified Terminated |
NLQ | K012669 |
| Jan 13, 2009 | Sterilmed Inc Harmonic Scalpel
Model #'s:
ETHACE14S
ETHACE23P
ETHACE36P
ETHCS14C
ETHFCS9
ETHHDH05
ETHLCS-C5 and
ETHLCSC5HA
Intended for use in soft tissue incisions when bleeding control and minimal thermal inju Terminated |
NLQ | K012571 K050343 |
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