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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

Company510(k)sRecalls
Boston Scientific553
Galil Medical , Ltd.297
CSA Medical, Inc.142
Endocare, Inc.131
Cooper Surgical, Inc.013
AtriCure, Inc.83
C2 Therapeutics81
Cryomedical Sciences, Inc.90
OraSure Technologies, Inc.63
Cryoconcepts LP80
Decided510(k)Device and applicantCode
Dec 3, 1981K813024WA1000
Wallach Surgical Devices, Inc.
GEH
Jun 16, 1981K811390CCS100 CRYOSURGICAL SYSTEM
Frigitronics of Connecticut, Inc.
GEH
Mar 20, 1981K810409MODEL C2100-SERIES OPHTHALMIC CRYOPROBE
Valleylab, Inc.
GEH
Feb 4, 1981K803311LL100 CRYOSURGICAL SYSTEM
Wallach Surgical Devices, Inc.
GEH
Oct 31, 1980K801921GCS-79
Gilmore Liquid Air Co.
GEH
Apr 4, 1980K800335KRYMED LIQUID NITROGEN CRYOJET
Cryomedics, Inc.
GEH
Jan 10, 1979K781956CRYOSURGICAL DEVICE 2000
Valleylab, Inc.
GEH
Dec 15, 1977K772232LIQUID NITROGEN SPRAY UNIT
Gilmore Liquid Air Co.
GEH
Dec 6, 1977K771320CRYOSURGICAL EQUIPMENT
A.S.M.O.T.
GEH
Feb 17, 1977K770058PROBE, VACUUM INSULATED, SERIES 30
Spembly Medical , Ltd.
GEH
Nov 16, 1976K760953DEEP FREEZE SYSTEM (DFS-30)
Spembly Medical , Ltd.
GEH
Nov 3, 1976K760742CS-76 AND/OR CRYOCARE I
Frigitronics of Connecticut, Inc.
GEH
Nov 1, 1976K760686CRYOLYZER ALPHA (CRYOSURG.EQUIP.)
Cryo-Labs, Inc.
GEH
Oct 29, 1976K760353CRYOLYZER ALPHA
Pilling Co.
GEH

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