FDA Device Registration & Listing · Sturtevant, WI, US · Registration 3013840437
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| OUP | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite | General, Plastic Surgery | Class 2 | 878.4790 | 2016-01-15 |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | General, Plastic Surgery | Class 2 | 878.4590 | 2024-02-06 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2019-10-24 |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | General, Plastic Surgery | Class 2 | 878.4590 | 2024-02-06 |
| PKO | Transparent Patch For Use In Treatment Of Tattoos | General, Plastic Surgery | Class 2 | 878.4810 | 2020-09-23 |
| LMH | Implant, Dermal, For Aesthetic Use | Unknown | Class 3 | N/A | 2007-12-17 |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | General, Plastic Surgery | Class 2 | 878.4590 | 2019-10-23 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2019-10-23 |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | General, Plastic Surgery | Class 2 | 878.4590 | 2016-01-15 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2016-01-15 |
| OJV | Single Use Instrument Tray | General, Plastic Surgery | Class 1 | 878.4800 | 2010-11-02 |
| LMH | Implant, Dermal, For Aesthetic Use | Unknown | Class 3 | N/A | 2007-12-04 |
| PKY | Implant, Dermal, For Aesthetic Use In The Hands | Unknown | Class 3 | N/A | 2007-12-04 |
| OUP | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite | General, Plastic Surgery | Class 2 | 878.4790 | 2016-10-28 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2025-07-24 |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | General, Plastic Surgery | Class 2 | 878.4590 | 2025-07-24 |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | General, Plastic Surgery | Class 2 | 878.4590 | 2024-02-06 |
| LMH | Implant, Dermal, For Aesthetic Use | Unknown | Class 3 | N/A | 2011-12-14 |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | General, Plastic Surgery | Class 2 | 878.4590 | 2024-02-06 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2024-02-06 |
| MIX | System, Vocal Cord Medialization | Ear, Nose, Throat | Class 2 | 874.3620 | 2007-12-17 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | Ear, Nose, Throat | Class 2 | 874.3620 | 2007-12-04 |
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2011-02-24 |
| LNM | Agent, Bulking, Injectable For Gastro-Urology Use | Unknown | Class 3 | N/A | 2007-12-04 |
| LMH | Implant, Dermal, For Aesthetic Use | Unknown | Class 3 | N/A | 2026-05-27 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2014-09-09 |
| FHR | Needle, Gastro-Urology | General, Plastic Surgery | Class 1 | 878.4800 | 2019-06-10 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K221336 | Revelle Aesthetics, Inc. | Avéli | 2022-08-05 |
| K863293 | Lifestream Int'L, Inc. | DISPOSABLE SUCTION CANNULA NO. 902008-000 | 1986-09-09 |
| K882805 | Coopervision-Cilco | CILCO VILLASENOR PACHYMETER | 1988-08-12 |
| K791040 | Shimadzu Corp. | SECTOR SCANNER, SDU-100, COMPUTERIZED | 1979-10-04 |
| K162372 | Qt Ultrasound, LLC | QT Ultrasound Breast Scanner-1 | 2017-06-06 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0003-2011 | Verathon, Inc. | 2 | BVI 9600 Bladder Volume Instrument, Aorta Scan Mode
The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements. |
| Z-0004-2011 | Verathon, Inc. | 2 | AortaScan AMI 9700
The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements |
| Z-0005-2011 | Verathon, Inc. | 2 | BladderScan BVM 9500
The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively. |
| Z-0027-2014 | SonoSite, Inc. | 2 | P21x/5-1 MHz transducer, Part Number P07698-23
Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler. |
| Z-0040-06 | Boston Scientific Corporation | 3 | Enteryx Procedure Kit
Order No.: M00572600 -US and M00572500 -OUS |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3003707320 | Tiger Aesthetics Medical-SD | San Diego, CA, US |
| 3042228064 | OMAN MEDICAL BEAUTY MANUFACTURE LIMITED | Hong Kong, HK |
| 3023808190 | BEIJING PERFECTLASER TECHNOLOGY CO.,LTD | Beijing, CN |
| 3043011436 | HEBEI MITA BIOTECHNOLOGY LIMITED | Hong Kong, HK |
| 1721676 | Sterigenics U.S., LLC | Salt Lake City, UT, US |
3013840437 when referencing this establishment in official correspondence.