Panels › General, Plastic Surgery › Product code GEH · Class 2
Unit, Cryosurgical, Accessories
Regulation 878.4350
9510(k)s in 12 months (264 all time)
5recalls in 12 months (107 all time)
87recalls that name a 510(k)
Top companies in GEH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 18, 2005 | K052530 | SEEDNET, SEEDNET GOLD, CRYOHIT, CRYOTHERA Galil Medical , Ltd. | GEH |
| Nov 15, 2005 | K052861 | MODIFICATION TO:SANARUS VISICA TREATMENT SYSTEM , MODELS VS2000 Sanarus Medical, Inc. | GEH |
| Jul 27, 2005 | K051509 | ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES Erbe USA, Inc. | GEH |
| May 6, 2005 | K051052 | SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM) Galil Medical , Ltd. | GEH |
| Feb 25, 2005 | K050347 | MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM Endocare, Inc. | GEH |
| Oct 14, 2004 | K042667 | SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD) Galil Medical , Ltd. | GEH |
| Sep 28, 2004 | K041783 | POLAR WAND Chek-Med Systems | GEH |
| May 21, 2004 | K040809 | CRYMED CRYO-ABLATOR Crymed Technologies, Inc. | GEH |
| Sep 10, 2003 | K032271 | WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022) Wartner USA B.V., CA | GEH |
| Aug 29, 2003 | K031697 | DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226 Schering-Plough Healthcare Products, Inc. | GEH |
| Aug 12, 2003 | K032333 | CRYOCARE CS SURGICAL SYSTEM Endocare, Inc. | GEH |
| Jun 27, 2003 | K030838 | WARTNER PRO Wartner Medical Products, CA | GEH |
| May 23, 2003 | K031117 | SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM Galil Medical , Ltd., IL | GEH |
| Apr 29, 2003 | K030303 | FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE Cryocath Technologies, Inc., CA | GEH |
| Mar 20, 2003 | K024009 | CRYOPROBE H&O Equipments, Nv/Sa | GEH |
| Mar 20, 2003 | K023487 | HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME OraSure Technologies, Inc. | GEH |
| Dec 5, 2002 | K023757 | CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 Endocare, Inc. | GEH |
| Oct 15, 2002 | K022314 | SANARUS VISICA TREATMENT SYSTEM Sanarus Medical, Inc. | GEH |
| Jul 31, 2002 | K021387 | POLAR WAND Chek-Med Systems | GEH |
| Jul 3, 2002 | K021261 | SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 Galil Medical , Ltd. | GEH |
| Jun 26, 2002 | K021211 | MODIFICATION TO SANARUS VISICA TREATMENT SYSTEM Sanarus Medical, Inc. | GEH |
| Apr 26, 2002 | K012214 | CRYOPEN AND ACCESSORIES Cimex Biotech, LLC | GEH |
| Mar 8, 2002 | K020605 | SANARUS VISICA TREATMENT SYSTEM Sanarus Medical, Inc. | GEH |
| Feb 20, 2002 | K011708 | MODIFICATION TO WARTNER WART REMOVAL SYSTEM Wartner Medical Products, CA | GEH |
| Jan 29, 2002 | K011950 | SEEDNET, MODEL FP6T5, FP5T5, FP5T3 Galil Medical , Ltd. | GEH |
| Jan 25, 2002 | K011074 | CRYOCARE SURGICAL SYSTEM Endocare, Inc. | GEH |
| Oct 30, 2001 | K012497 | CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1 Galil Medical , Ltd. | GEH |
| Oct 11, 2001 | K003811 | CRYOCARE SURGICAL SYSTEM Endocare, Inc. | GEH |
| Aug 22, 2001 | K011073 | CRYOPLAN SYSTEM Cryomedical Sciences, Inc. | GEH |
| May 3, 2001 | K010991 | SEEDNET, MODELS FP6T5, FP5T5, FP5T3 Galil Medical , Ltd. | GEH |
| Nov 28, 2000 | K002714 | WARTNER WART REMOVAL SYSTEM Wartner Medical Products, CA | GEH |
| Nov 13, 2000 | K002615 | SURGICAL SYSTEM WITH CRYOGUIDE Endocare, Inc. | GEH |
| Oct 31, 2000 | K003065 | SEEDNET, MODEL EP6T5, EP5E5 Galil Medical , Ltd. | GEH |
| Feb 18, 2000 | K993965 | CRYO-HIT Galil Medical , Ltd. | GEH |
| Aug 12, 1999 | K991792 | CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE Influence, Inc. | GEH |
| Jul 27, 1999 | K991517 | CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 Galil Medical , Ltd. | GEH |
| Jul 12, 1999 | K991272 | CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E Galil Medical , Ltd. | GEH |
| Jul 1, 1999 | K991122 | CRYO-MONO CRYOGRNIC SYSTEM Influence, Inc. | GEH |
| Jun 14, 1999 | K990877 | HISTOFREEZER DEVICE OraSure Technologies, Inc. | GEH |
| Jan 27, 1999 | K982506 | VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM Cryosurgery, Inc. | GEH |
| Nov 25, 1998 | K982280 | CRYOPRO MAXI AND CRYOPRO MINI Cortex Technology Aps | GEH |
| Oct 2, 1998 | K982358 | HISTOFREEZER DEVICE OraSure Technologies, Inc. | GEH |
| Sep 8, 1998 | K982055 | ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880 Cryomedical Sciences, Inc. | GEH |
| Jul 17, 1998 | K980670 | CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722 Cryomedical Sciences, Inc. | GEH |
| Jul 17, 1998 | K980668 | CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790 Cryomedical Sciences, Inc. | GEH |
| May 26, 1998 | K980739 | HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS OraSure Technologies, Inc. | GEH |
| Apr 10, 1998 | K980110 | ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM Endocare, Inc. | GEH |
| Dec 22, 1997 | K973686 | ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM Endocare, Inc. | GEH |
| Oct 21, 1997 | K971392 | HISTOFREEZER VERRUCA PLANA OraSure Technologies, Inc. | GEH |
| Oct 1, 1997 | K972662 | CRYOGEN CRYOSURGICAL SYSTEM Cryogen, Inc. | GEH |
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