Product code LFL ยท Class U
Instrument, Ultrasonic Surgical
3510(k)s in 12 months (160 all time)
13recalls in 12 months (109 all time)
99recalls that name a 510(k)
Top companies in LFL
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 6, 2014 | K141668 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM Integra LifeSciences Corporation | LFL |
| Aug 7, 2014 | K141371 | SONICISION CORDLESS ULTRASONIC DISSECTOR Covidien, Formerly Valleylab, A Division of Tyco H | LFL |
| Dec 16, 2013 | K132522 | HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE Ethicon Endo-Surgery, LLC | LFL |
| Dec 3, 2013 | K133314 | HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY Ethicon Endo-Surgery, LLC | LFL |
| Oct 24, 2013 | K132512 | HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE Ethicon Endo-Surgery, LLC | LFL |
| Oct 17, 2013 | K132612 | HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE Ethicon Endo-Surgery, LLC | LFL |
| Mar 20, 2013 | K123640 | TX1 TISSUE REMOVAL SYSTEM Tenex Health | LFL |
| Aug 22, 2012 | K121550 | HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY Ethicon Endo-Surgery, LLC | LFL |
| May 17, 2012 | K120729 | HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23 Ethicon Endo-Surgery, LLC | LFL |
| Feb 22, 2012 | K113570 | INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP Integra Burlington Ma, Inc. | LFL |
| Aug 23, 2011 | K111741 | INTEGRA(TM) CUSA NXT(TM) BONE TIPS Integra Burlington Ma, Inc. (Formerly Integra Radi | LFL |
| Jun 10, 2011 | K102258 | CUSA NXT EXTENDED LENGTH TIP Integra Radionics, Inc. | LFL |
| Feb 24, 2011 | K101797 | SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T Covidien, Formerly Valleylab, A Division of Tyco | LFL |
| Aug 27, 2010 | K101561 | TX1 TISSUE REMOVAL SYSTEM American Optisurgical, Inc. | LFL |
| Apr 7, 2010 | K100597 | HARMONIC FOCUS SHEARS Ethicon Endo-Surgery, LLC | LFL |
| May 8, 2009 | K090864 | CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM Integra Radionics, Inc. | LFL |
| Aug 13, 2008 | K081459 | CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM Integra Radionics, Inc. | LFL |
| May 21, 2008 | K072904 | SONOCA 180/195 WOUND CARE SYSTEM Soering GmbH | LFL |
| Sep 25, 2007 | K072203 | HARMONIC 10CM COMBINATION HOOK BLADE Ethicon Endo-Surgery, LLC | LFL |
| Aug 17, 2007 | K071669 | INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP Integra Radionics, Inc. | LFL |
| Aug 7, 2007 | K070360 | KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 Kirwan Surgical Products, Inc. | LFL |
| May 11, 2007 | K070313 | MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM Misonix, Inc. | LFL |
| Feb 22, 2007 | K063531 | SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM Sra Developments, Ltd., GB | LFL |
| Jan 30, 2007 | K063192 | HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP Ethicon Endo-Surgery, LLC | LFL |
| Jan 3, 2007 | K062544 | AR1000 ULTRASONIC WOUND THERAPY SYSTEM Arobella Medical, LLC | LFL |
| Oct 26, 2006 | K062471 | ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF Misonix, Inc. | LFL |
| Sep 25, 2006 | K062000 | HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH Ethicon Endo-Surgery, Inc. | LFL |
| Apr 7, 2006 | K060245 | HARMONIC SCALPEL BLADES AND SHEARS Ethicon Endo-Surgery, Inc. | LFL |
| Jan 19, 2006 | K053056 | HARMONIC SCALPEL BLADES AND SHEARS Ethicon Endo-Surgery, Inc. | LFL |
| Aug 22, 2005 | K051947 | RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE Radionics, A Division of Tyco Healthcare Group LP | LFL |
| Jun 6, 2005 | K050776 | AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM Misonix, Inc. | LFL |
| Jun 3, 2005 | K050885 | OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG Olympus Medical Systems Corporation | LFL |
| Jun 2, 2005 | K051036 | HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P Ethicon Endo-Surgery, Inc. | LFL |
| Jan 25, 2005 | K042160 | SONOSURG TROCAR Aomori Olympus Co., Ltd. | LFL |
| Dec 1, 2004 | K042777 | HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P Ethicon Endo-Surgery, Inc. | LFL |
| Sep 29, 2004 | K042277 | SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM Integra Neurosciences, Ltd., GB | LFL |
| Sep 8, 2004 | K041566 | SONOSURG ULTRASONIC SURGICAL SYSTEM Aomori Olympus Co., Ltd. | LFL |
| Dec 16, 2003 | K032424 | LOTUS Sra Developments, Ltd. | LFL |
| Dec 9, 2003 | K032690 | MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM Misonix, Inc. | LFL |
| Oct 3, 2003 | K032066 | SONOSURG SYSTEM The Olympus Optical Co. | LFL |
| Oct 1, 2003 | K031523 | OLYMPUS ULTRASONIC SURGICAL SYSTEM Aomori Olympus Co., Ltd. | LFL |
| Sep 23, 2003 | K031305 | OLYMPUS ULTRASONIC SURGICAL SYSTEM Olympus Optical Co., Ltd. | LFL |
| Aug 29, 2003 | K031710 | OLYMPUS ULTRASONIC SURGICAL SYSTEM Aomori Olympus Co., Ltd. | LFL |
| Feb 12, 2003 | K021962 | OLYMPUS ULTRASONIC SURGICAL SYSTEM The Olympus Optical Co. | LFL |
| Sep 13, 2002 | K021989 | SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 Integra Neurosciences | LFL |
| Sep 10, 2002 | K021929 | AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM Axya Medical, Inc. | LFL |
| Aug 23, 2002 | K020220 | ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE Synergetics, Inc. | LFL |
| Nov 13, 2001 | K012753 | SORING GMBH SONOCA 180/190 Soring GmbH Medizintechnik | LFL |
| Oct 1, 2001 | K012176 | ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145 Ethicon Endo-Surgery, Inc. | LFL |
| Jul 27, 2001 | K012028 | ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 Misonix, Inc. | LFL |
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