510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Ellman International, Inc.

Oceanside, NY, US

Ellman International, Inc. appears in FDA device records in Oceanside, NY. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
2
Registered establishments
0

510(k) clearance history

FDA records hold 5 510(k) clearances for Ellman International, Inc. between 2006 and 2014. The busiest year on record is 2013, with 2. The most recent is 2014, with 1.

Clearances by year, as a table
510(k) clearance decisions for Ellman International, Inc., by decision year
YearClearances
20061
20081
20132
20141
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K132949PELLEFIRMPBXSubstantially Equivalent
K132665PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IECGEISubstantially Equivalent
K123366SURGITRON 4.0 DUAL RF S5-IECGEISubstantially Equivalent
K071343ELLMAN NOBLE ALLOY ELECTRODESGEISubstantially Equivalent
K052241DISC-FX SYSTEMHRXSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0748-2017ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar waveform.Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not match. The expiration date on the box is correct with a date of 2018-02.Class IITerminated
Z-1624-2012Pelleve Non-Ablative Wrinkle Treatment Handpiece, Product Codes D110FSHP, D115FSHP (reusable) --- Pelleve --- Elegance through science --- Contents: One (1) Pelleve Handpiece (Reusable) --- Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV.Ellman International is recalling its Pelleve reusable handpiece because of possible cable failure and sparking.Terminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Ellman International, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

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