510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Neuwave Medical, Inc.

Madison, WI, US

NEUWAVE MEDICAL, INC. appears in FDA device records in Madison, WI. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
15
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 15 510(k) clearances for Neuwave Medical, Inc. between 2010 and 2024. The busiest year on record is 2012, with 2. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Neuwave Medical, Inc., by decision year
YearClearances
20101
20122
20131
20151
20162
20172
20181
20191
20201
20221
20231
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232227ABLATE-IQJAKSubstantially Equivalent
K231738NEUWAVE™ Microwave Ablation System and AccessoriesNEYSubstantially Equivalent
K220472NEUWAVE Microwave Ablation System and AccessoriesNEYSubstantially Equivalent
K200081NEUWAVE Microwave Ablation System and AccessoriesNEYSubstantially Equivalent
K192427Ablation ConfirmationJAKSubstantially Equivalent
K173756Certus 140 2.45GHz Ablation SystemNEYSubstantially Equivalent
K171022Ablation ConfirmationJAKSubstantially Equivalent
K163118FLEX Microwave Ablation System and AccessoriesNEYSubstantially Equivalent
K161285Ablation ConfirmationJAKSubstantially Equivalent
K160936Certus 140 2.45GHz Ablation SystemNEYSubstantially Equivalent
K150313Ablation ConfirmationLLZSubstantially Equivalent
K130399CERTUS 140 CERTUSURGGT SURGICAL TOOLNEYSubstantially Equivalent
K122217CERTUS 140 2.45GHZ ABLATION SYSTEMNEYSubstantially Equivalent
K113237CERTUS 140 2.45GHZ ABLATION SYSTEMNEYSubstantially Equivalent
K100744CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140NEYSubstantially Equivalent

Registered establishments

FDA registered establishments for Neuwave Medical, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30087697563008769756NEUWAVE MEDICAL, INC.3529, 3513(Suite 100) and 3543 Anderson Street, Madison, WI 53704 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain