FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
673–696 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 16, 2023
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
K230314 · LZA
New Era Medicare Sdn. Bhd.
General Hospital · 191d
Cleared Aug 16, 2023
Celsi Monitor
K230298 · FLL
Hadleigh Health Technologies
General Hospital · 195d
Cleared Aug 12, 2023
TK Pre-Filled Normal Saline Flush Syringe
K230756 · NGT
Anhui Tiankang Medical Technology...
General Hospital · 145d
Cleared Aug 12, 2023
Pre-Filled Normal Saline Flush Syringe
K223584 · NGT
Anhui Tianyang Pharmaceutical Co., Ltd.
General Hospital · 254d
Cleared Aug 11, 2023
Powder Free White, Black, and Purple Nitrile Examination Glove
K231439 · LZA
S&S Glove Corporation
General Hospital · 86d
Cleared Aug 11, 2023
Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile
K231408 · LZA
Shandong Intco Medical Products Co, Ltd.
General Hospital · 88d
Cleared Aug 11, 2023
PolyWear® Personal Protective Level 3 Gown
K230384 · QPC
PolyConversions, Inc.
General Hospital · 178d
Cleared Aug 09, 2023
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K232039 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 30d
Cleared Aug 09, 2023
Polyisoprene Surgical Gloves
K230304 · KGO
Puyang Linshi Medical Supplies Co., Ltd.
General Hospital · 187d
Cleared Aug 08, 2023
Disposable Medical Examination Nitrile Gloves
K232008 · LZA
Raxwell Industrial, LLC
General Hospital · 33d
Cleared Aug 08, 2023
Protective Gown AAMI Level 4
K222128 · QPC
Kenpax International Limited
General Hospital · 386d
Cleared Aug 07, 2023
PRO-LITE Sterilization Tray
K231501 · KCT
STERIS Corporation
General Hospital · 75d
Cleared Aug 07, 2023
Vis-U-All Low Temperature Sterilization Pouches
K231500 · FRG
STERIS Corporation
General Hospital · 75d
Cleared Aug 07, 2023
Celerity 20 HP Biological Indicator
K231490 · FRC
STERIS Corporation
General Hospital · 76d
Cleared Aug 07, 2023
Celerity™ HP Chemical Indicator
K231488 · JOJ
Steris
General Hospital · 76d
Cleared Aug 07, 2023
Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy...
K223713 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 238d
Cleared Aug 07, 2023
V-PRO maX 2 Low Temperature Sterilization System
K223476 · MLR
STERIS Corporation
General Hospital · 262d
Cleared Aug 04, 2023
iTEMPSHIELD
K232010 · FLL
Aion Biosystems, Inc.
General Hospital · 29d
Cleared Aug 03, 2023
Surgical Face Masks, Model: EFMDS-L50Pn BLU
K230380 · FXX
Iris USA
General Hospital · 171d
Cleared Aug 02, 2023
Chemfort® Catheter Adaptor
K231286 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 90d
Cleared Jul 28, 2023
3 Layer Surgical Mask (134252531)
K231618 · FXX
Original Mattress Factory, Inc.
General Hospital · 56d
Cleared Jul 27, 2023
Altaviz Needle Kit II
K231261 · FMI
Altaviz, LLC
General Hospital · 87d
Cleared Jul 27, 2023
Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™...
K230838 · FYA
Cardinal Health200, LLC
General Hospital · 122d
Cleared Jul 25, 2023
EZ-IO Intraosseous Vascular Access System
K231924 · FMI
Teleflex Medical
General Hospital · 25d