ClearanceBrief
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)
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Top companies in GEH

Decided510(k)Device and applicantCode
Jul 7, 1997K970995CMS CRYOLITE
Cryomedical Sciences, Inc.
GEH
Jun 17, 1997K970992PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS
Premier Dental Products Co.
GEH
May 29, 1997K971216FRIGIDERM FRIGISPRAY
Dermatologic Lab & Supply, Inc.
GEH
Mar 28, 1997K964971CRYOGEN CRYOSURGICAL SYSTEM
Cryogen, Inc.
GEH
Mar 20, 1997K964336CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680
Cryomedical Sciences, Inc.
GEH
Mar 19, 1997K964047CRYOSIL SILICONE GEL SHEETING
Biodermis Corp.
GEH
Feb 25, 1997K963970ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM
Endocare, Inc.
GEH
Dec 18, 1996K963826ENDOCARE CRYCARE CRYOSURGICAL SYSTEM
Endocare, Inc.
GEH
Jun 21, 1996K961219PERCUTANEOUS INTRODUCER SYSTEM
Boston Scientific Corp
GEH
Apr 3, 1996K955011CANDELA HCS 2000 URETHERAL WARMER CATHETER
Candela Laser Corp.
GEH
Apr 1, 1996K960387UROSPROBE SYSTEM, MODEL 1000
Uros Corp.
GEH
Feb 8, 1996K955083VERRUCA-FREEZE CRYOSURGICAL DELIVERY SYSTEM (MODIFICATION)
Cryosurgery, Inc.
GEH
Feb 8, 1996K954703MEDI-FRIG
Ellman Intl., Inc.
GEH
Feb 5, 1996K954872CANDELA CRYO-PROBE HOLDER
Candela Laser Corp.
GEH
Dec 4, 1995K953637CMS ACCUPROBE 550/530
Cryomedical Sciences, Inc.
GEH
Oct 24, 1995K952895CMS URETHRAL WARMER
Cryomedical Sciences, Inc.
GEH
Oct 18, 1995K953294CANDELA CRYOSYSTEM CS-5
Candela Laser Corp.
GEH
Jan 19, 1995K942299ENDOCARE CRYOTHERAPY SYSTEM
Cytocare, Inc.
GEH
Dec 15, 1994K944221VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED
Cryosurgery, Inc.
GEH
Jun 27, 1994K940140HM-CRYO
Hill-Med, Inc.
GEH
Apr 26, 1994K934261ERBOKRYO CA CRYOSURGICAL SYSTEM
Erbe Elektromedizin GmbH
GEH
Apr 26, 1994K912529ERGOMED
Kryoderm USA, Inc.
GEH
Feb 9, 1994K935010WALLACH ULTRA FREEZE
Wallach Surgical Devices, Inc.
GEH
Oct 29, 1993K933327HISTOFREEZER
Solarcare, Inc.
GEH
Aug 24, 1993K926464L.C.S.3000
Cryodyne Technologies, Inc.
GEH
Aug 11, 1993K931299HISTOFREEZER
Solarcare Technologies Corp,Inc.
GEH
Feb 5, 1993K924114HISTOFREEZER
Solarcare Technologies Corp,Inc.
GEH
Sep 2, 1992K922878MODEL GT1ST CRYOSURGICAL INSTRUMENT
Gyne-Tech Instrument Corp.
GEH
Jan 14, 1992K914591L.C.S. 2000 SYSTEM
Stiefel Research Institute, Inc.
GEH
Jun 28, 1991K911420HISTOFREEZER
Solarcare Technologies Corp,Inc.
GEH
May 21, 1991K910491WALLACH COLD SOAKER
Wallach Surgical Devices, Inc.
GEH
Apr 8, 1991K904421CMS ONCOPROBE (TM)
Cryomedical Sciences, Inc.
GEH
Jan 9, 1990K896724CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU.
Stiefel Research Institute, Inc.
GEH
Jul 25, 1989K892237THE FERN CRYOPROBE
Cryogenic Instruments & Equipment , Ltd., GB
GEH
Jun 15, 1989K891282MIC-100 WITH CRYOPROBES
Frigitronics of Connecticut, Inc.
GEH
Sep 27, 1988K882568130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY
Spembly Medical , Ltd., GB
GEH
Sep 26, 1988K880416WCCS 800 WALLACH CARDIAC CRYOSURGICAL SYSTEM
Wallach Surgical Devices, Inc.
GEH
Aug 8, 1988K882963SPEMBLY MEDICAL 142 CRYO UNIT
Spembly Medical , Ltd., GB
GEH
Aug 8, 1988K882962SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)
Spembly Medical , Ltd., GB
GEH
Jun 30, 1988K881349VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM
Cryosurg, Inc.
GEH
Jul 23, 1987K872796ADDITIONS TO WSL NITROSPRAY CRYOSURGICAL UNITS
Tower Mfg. Co., Inc.
GEH
Apr 28, 1987K871314CRYOSURGICAL PROBE
Western Medical Research
GEH
Jan 24, 1986K854767LM 1000
Leisegang Medical, Inc.
GEH
Feb 28, 1985K844246NETHERY EXTREMITY FREEZING UNIT
Howard J. Nethery & Assoc.
GEH
Dec 7, 1984K842959MC-4000 CONSOLE & PROBES
Cryomedics, Inc.
GEH
Aug 1, 1984K842704MT-700 MT-750 FT-350
Cryomedics, Inc.
GEH
Apr 23, 1984K840536CRYO SURG 5900
Frigitronics of Connecticut, Inc.
GEH
Sep 12, 1983K832385CRYOPROBES MC-1400-CRYOSURG-CONSOLE
Spembly Medical , Ltd.
GEH
Aug 12, 1983K832334CRYOMEDICS 5000 CRYOSURGICAL CONSOLE
Spembly Medical , Ltd.
GEH
Aug 12, 1983K832140CRYOMEDICS 5000 CRYOPROBES
Spembly Medical , Ltd.
GEH

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