FDA.reportPublic FDA data

Surgical helmet system

Definition
A system intended for the purpose of protecting healthcare workers and patients from cross-infection during surgery. It is typically composed of a helmet frame with a face shield, a loose fitting disposable hood or gown draped around this, inflow and exhaust fans and filters, and a power supply, e.g., a battery pack to drive the internal ventilation.
GUDID devices
88
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850078013026MAXAIRSyntech, Int'l Inc.2084-04-PR2026-04-24
00850078013033MAXAIRSyntech, Int'l Inc.2500-36TSC-PR2026-04-24
00850078013040MAXAIRSyntech, Int'l Inc.2500-37TSC-PR2026-04-24
00850078013064MAXAIRSyntech, Int'l Inc.2085-03-IR2026-04-24
00850078013071MAXAIRSyntech, Int'l Inc.2600-02-PR2026-04-24
00889024376267TOTALSHIELD®Zimmer, Inc.00-9900-004-002017-11-07
00889024376434TOTALSHIELD® ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-9900-301-122017-11-07
00889024376441TOTALSHIELD®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-9900-310-102017-11-07
00889024376458TOTALSHIELD®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-9900-311-102017-11-07
00889024376465TOTALSHIELD®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-9900-312-102017-11-07
00889024464681TOTALSHIELD®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-9910-301-122017-11-07
00889024553477TotalShield® II Surgical HoodZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.009920401122019-12-18
00889024553491TotalShield® II Zippered Surgical Toga, LargeZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.009920411102019-12-18
00889024553507TotalShield® II Zippered Surgical Toga, XLZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.009920412102019-12-18
00889024553514TotalShield® II Zippered Surgical Toga, 2XLZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.009920413102019-12-18
04546540186799NASTRYKER CORPORATION04002050002018-09-24
04546540591562FlyteSTRYKER CORPORATION04082100002018-09-24
07613154272266NASTRYKER CORPORATION04002100002018-09-24
09009607811003ViVi® HELMET25THI Total Healthcare Innovation GmbH811002025-11-10
09009607811010ViVi® HELMET25 XLTHI Total Healthcare Innovation GmbH81100XL2025-11-10
09009607811300ViVi® HELMET25 HPLTHI Total Healthcare Innovation GmbH811302025-11-10
09009607811317ViVi® HELMET25 XL HPLTHI Total Healthcare Innovation GmbH81130XL2025-11-10
07613327625134Steri-ShieldSTRYKER CORPORATION0424-600-0002025-02-26
07613327625202Steri-ShieldSTRYKER CORPORATION04246600002025-02-26
07613327627039STERI-SHIELDSTRYKER CORPORATION04246100002025-02-26
07613327625158Steri-ShieldSTRYKER CORPORATION04246550002025-02-21
09009607801004ViVi HelmetTHI Total Healthcare Innovation GmbH801002023-11-10
09009607801301ViVi Helmet HPLTHI Total Healthcare Innovation GmbH801302023-11-10
00889024597426TOTALSHIELD® IIZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.009920005002020-12-21
00889024597433TOTALSHIELD® IIZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.009920006002020-12-21
10850017419206ProneViewDUPACO, INC.D28501CE2020-10-30
10850017419213ProneViewDUPACO, INC.D28502CE2020-10-30
10850017419220ProneViewDUPACO, INC.D28520CE2020-10-30
10850017419237ProneViewDUPACO, INC.D28520DE2020-10-30
10850017419244ProneViewDUPACO, INC.D28580CE2020-10-30
00889024595439TOTALSHIELD® IIZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00992003072020-09-23
07613327461312N/ASTRYKER CORPORATION0416-600-0002020-08-06
07613327461336N/ASTRYKER CORPORATION0416-610-0002020-08-06
00889024376236TOTALSHIELD®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-9900-001-002016-08-12
00889024376243TOTALSHIELD®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-9900-002-002016-08-12
00889024376250TOTALSHIELD®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-9900-003-062016-08-12
00889024376403TOTALSHIELD®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-9900-104-002016-08-12
00889024376410TOTALSHIELD® ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-9900-200-002016-08-12
00889024376427TOTALSHIELD® ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-9900-200-022016-08-12
00889024378438TOTALSHIELD®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.89-9901-000-002016-09-19
00889024380349TOTALSHIELD®Zimmer, Inc.00-9900-004-002017-11-07
00889024380356TOTALSHIELD® ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-9900-301-122017-11-07
00889024380363TOTALSHIELD®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-9900-310-102017-11-07
00889024380370TOTALSHIELD®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-9900-311-102017-11-07
00889024380387TOTALSHIELD®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-9900-312-102017-11-07
00889024464698TOTALSHIELD®ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.00-9910-301-122017-11-07
00889024553521TotalShield® II Zippered Surgical Toga, 3XLZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.009920414102019-12-18
00889024553705TotalShield® II Surgical HoodZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.009920401122019-12-18
00889024553729TotalShield® II Zippered Surgical Toga, LargeZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.009920411102019-12-18
00889024553736TotalShield® II Zippered Surgical Toga, XLZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.009920412102019-12-18
00889024553743TotalShield® II Zippered Surgical Toga, 2XLZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.009920413102019-12-18
00889024553392TOTALSHIELD® IIZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.009920001002019-11-07
00889024553408TOTALSHIELD® IIZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.009920002002019-11-07
04546540152534NASTRYKER CORPORATION04006500002017-04-05
04546540152558NASTRYKER CORPORATION04006550022018-09-24
34546540186790NASTRYKER CORPORATION04002050002018-09-24
04546540427359CORESTRYKER CORPORATION54005000002018-09-24
04546540489579NASTRYKER CORPORATION04006100002018-09-24
04546540494153NASTRYKER CORPORATION04006450002018-09-24
04546540505019NASTRYKER CORPORATION0400610000S12018-09-24
04546540591579FlyteSTRYKER CORPORATION04086000002018-09-24
04546540591586FlyteSTRYKER CORPORATION04086003002018-09-24
04546540591593FlyteSTRYKER CORPORATION04086350002018-09-24
04546540591609FlyteSTRYKER CORPORATION04086450002018-09-24
04546540591623FlyteSTRYKER CORPORATION04086550022018-09-24
04546540591630FlyteSTRYKER CORPORATION04086552002018-09-24
04546540591647FlyteSTRYKER CORPORATION04086553002018-09-24
04546540591654NASTRYKER CORPORATION04086600002018-09-24
04546540592675FlyteSTRYKER CORPORATION04086053002018-09-24
34546540591563FlyteSTRYKER CORPORATION04082100002018-09-24
04546540670069NASTRYKER CORPORATION04006550032018-09-24
04546540903839NASTRYKER CORPORATION04006550002018-09-24
04546540903877NASTRYKER CORPORATION04006550012018-09-24
37613154272267NASTRYKER CORPORATION04002100002018-09-24
07613154368167NASTRYKER CORPORATION04006750002018-09-24