Atlas FDA

DWL

64 FDA 510(k) clearances · Product code

80 daysmedian time to decision
218 days90th percentile
64clearances measured

FDA profile

Official device name
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5780
Medical specialty
General Hospital
Adverse events (MAUDE)
2004: 3 · 2005: 3 · 2006: 2 · 2009: 3 · 2010: 7 · 2012: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MEDLINE ANTI-EMBOLISM STOCKING (K141127)Medline Industries, Inc.2014-08-21
BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) (K131496)Bsn Medical, Inc.2013-07-10
ENCIRCLE COMPRESSION THERAPY STOCKING (K122485)Encircle Medical Devices , Ltd.2013-04-23
BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS (K123820)Bossong Hosiery Mills, Inc.2013-04-02
FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE (K123085)3M Company2012-12-20
ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS (K123561)Bsn Medical, Inc.2012-12-18
DR. SCHOLL'S COMPRESSION SOCKS (K123398)Renfro Corporation2012-12-18
TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET (K121106)Surgical Appliance Industries, Inc.2012-04-27
CURAD COMPRESSION HOSIERY (K112769)Medline Industries, Inc.2012-03-01
VENOTRAIN CURAFLOW (K111662)Bauerfeind AG2011-10-04
HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 (K101614)Dm Systems, Incorporated2011-01-13
SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS (K101224)Griffiths and Nielsen, Ltd.2010-12-03
SHAPE TO FIT COMPRESSION WEAR (K101906)Tsung Hau Technology Co., Ltd.2010-09-17
1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613 (K092892)I-Ming Sanitary Materials Co., Ltd.2010-08-03
ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 (K090921)Beiersdorf, Inc.2009-12-18
THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS (K091141)Knit-Rite, Inc.2009-07-24
SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS (K062873)E.C.I. USA Corporation2007-03-20
TORBOT VASCULAR COMPRESSION GARMENTS (K061411)Torbut Group, Inc.2006-10-18
MEDI BUTLER (K051324)Medi USA, LP2005-12-05
FLIGHT SOCK (K040353)Ssl Americas, Inc.2004-03-11
JOBST TRAVEL SOCKS (K032325)Bsn-Jobst, Inc.2003-08-28
HYDROBOOT (K022233)Incappe, Inc.2002-08-12
BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES (K020538)Boehringer Laboratories2002-05-15
DM SLEEVE (K021102)Emily Iker M.D., A.P.C.2002-05-08
ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 (K020592)Alba-Waldensian, Inc.2002-04-03
JOBST READY-TO-WEAR GAUNTLET (K013852)Bsn-Jobst, Inc.2002-01-28
D. R. MEDICAL CONTROLLED PRESSURE GARMENTS (K001300)Confection Medicale D.R., Inc.2000-08-30
JOBST READY-TO-WEAR ARM SLEEVES (K991570)Beiersdorf-Jobt, Inc.1999-08-20
GEEN MEDISOX (K981296)Geen Healthcare, Inc.1998-05-29
OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS (K964103)Tournier-Bottu S.A.1997-01-06
ELVAREX (K963573)Jobst A Beiersdorf Co.1996-10-16
CAROLINA NARROW FABRIC COMPANY OPEN TOE ANTI-EMBOLISM STOCKING (K960931)Carolina Narrow Fabric Co.1996-05-23
CAROLINA NARROW FABRIC COMPANY CLOSED TOE ANTI-EMBOLISM STOCKING (K961177)Carolina Narrow Fabric Co.1996-04-15
ANTI-EM/GP STOCKINGS (K955138)Jobst Institute, Inc.1995-12-13
MARLENE STOCKINGS & TIGHTS (K954295)Professional Products, Inc.1995-11-08
MEDICAL SUPPORT STOCKINGS (K951234)Jobst A Beiersdorf Co.1995-05-18
MEDICAL SUPPORT STOCKINGS 2001/2002 (K943734)Julius Zorn, Inc.1994-10-19
MEDI STRUMPF (K941926)Medi USA, LP1994-06-15
JOBST-CUSTOM (K925154)Jobst Institute, Inc.1994-04-04
RX FIT MEDICAL STOCKINGS (K925643)Elastic Therapy, Inc.1993-12-06
KENDALL HOME RX THERAPEUTIC STOCKING (K925417)Kendall Healthcare Products Co. Div.Of Tyco Health1993-06-04
ULTIMATE (K920444)Jobst Institute, Inc.1992-04-20
JUZO-RESPIRA ANTI-EMBOLISM STOCKING (K905413)Julius Zorn, Inc.1991-05-17
COMPRINET, COMTESSE AND BELLAVAR STOCKINGS (K905631)Jobst Institute, Inc.1991-03-07
SCD THERAPEUTIC STOCKING SYSTEM (K902497)Kendall Healthcare Products Co. Div.Of Tyco Health1990-08-15
COMFORT SHEER FIRM AND SHEER SUPPORT PANTYHOSE (K894071)Sara Lee Corp.1989-10-18
ULCERCARE (K892867)Jobst Institute, Inc.1989-07-20
WRIGHT GRADIENT PRESSURE SUPPORT STOCKINGS (K883186)Wright Linear Pump, Inc.1988-11-21
ULTRACARE (K883633)Jobst Institute, Inc.1988-10-18
ENHANCE SUPPORT HOSE (K873280)Kimberly-Clark Corp.1987-10-09
SHEER ENERGY, ACTIVE & SILKY SUPPORT PANTY HOSE (K863699)Hanes Group1987-02-04
VENOTRAIN COLOR COMPRESSION STOCKINGS & PANTYHOSE (K860826)Bauerfeind GmbH & Co.1986-06-18
VASC-EZ (K854428)Barton-Carey Medical Products Co.1986-02-13
MED. SUPPORT STOCKING-VENOFIT LASTOFLEX (K842708)Kundt + Co. AG1984-10-09
GLATTELAST COMPRESSION PANTY HOSE (K841252)Baurs Krey Assoc., Inc.1984-06-27
GLATTELAST COMPRESSION STOCKINGS (K841215)Baurs Krey Assoc., Inc.1984-06-07
SHEER ENERGY PANTY HOSE (K840335)Leggs Products, Inc.1984-05-25
SURGICAL STOCKINGS (K832273)Wells Johnson Co.1983-10-19
A.V.R. KNEE LENGTH THERAPEUTIC STOCK- (K832609)The Kendal Co.1983-09-12
VENES HIGH COMPRESSION MEDICAL STOCK- (K830697)Futuro Div. Jung Corp.1983-04-30
VENES ANTI EMBOLISM STOCKINGS (K830696)Futuro Div. Jung Corp.1983-03-31
MADE-TO-MEASURE SURGICAL ELASTIC SUPPORT (K823737)Gotfried Medical, Inc.1983-01-12
AES STOCKINGS (K822446)Rampon Products1982-08-27
VENES II (K811085)Jung Products, Inc.1981-05-01

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