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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
481–504 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 08, 2023
IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA
K213510 · LTK
Siemens Healthcare Diagnostics...
Immunology · 675d
Cleared Sep 07, 2023
SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate,...
K230049 · HIS
Ttk Healthcare Limited
Obstetrics & Gynecology · 244d
Cleared Sep 05, 2023
F&P 820 Humidification System
K223684 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 271d
Cleared Sep 01, 2023
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
K232314 · FDS
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 30d
Cleared Sep 01, 2023
Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
K232021 · MOS
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 56d
Cleared Aug 31, 2023
23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for...
K223597 · QAZ
23AndMe, Inc.
Pathology · 272d
Cleared Aug 31, 2023
MedicloseTM System
K213271 · OCW
Health Value Creation B.V., Trading...
General & Plastic Surgery · 700d
Cleared Aug 30, 2023
Phoenix Contact Lens Case - dome top flat pack (CL-01)
K231123 · LRX
Phoenix Innovative Healthcare...
Ophthalmic · 132d
Cleared Aug 28, 2023
Alveoair Digital Spirometer
K222525 · BZG
Roundworks Technologies Private Limited
Anesthesiology · 371d
Cleared Aug 25, 2023
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully...
K230566 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 177d
Cleared Aug 24, 2023
Current Health System
K231506 · MSX
Current Health , Ltd.
Cardiovascular · 92d
Cleared Aug 23, 2023
Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown...
K230610 · FYA
Dongguan Shin YI Healthcare Products...
General Hospital · 170d
Cleared Aug 23, 2023
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low...
K230079 · KGO
Ansell Healthcare Products, LLC
General Hospital · 225d
Cleared Aug 18, 2023
Holmium Medical Laser
K231718 · GEX
Allengers Global Healthcare Private...
General & Plastic Surgery · 66d
Cleared Aug 16, 2023
Celsi Monitor
K230298 · FLL
Hadleigh Health Technologies
General Hospital · 195d
Cleared Aug 16, 2023
Kyphoplasty Balloon Catheter
K223709 · HRX
Jiangsu Changmei Medtech Co., Ltd.
Orthopedic · 247d
Cleared Aug 10, 2023
ANNE One
K223711 · DRG
Sibel Health, Inc.
Cardiovascular · 241d
Cleared Aug 09, 2023
Air Smart Extra Spirometer
K222443 · BZG
Feellife Health, Inc.
Anesthesiology · 362d
Cleared Aug 08, 2023
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
K222439 · LEH
Siemens Healthcare Diagnostics, Inc.
Toxicology · 361d
Cleared Aug 07, 2023
Reprocessed Agilis NxT Steerable Introducer
K230376 · PNE
Innovative Health, LLC
Cardiovascular · 175d
Cleared Aug 04, 2023
T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button,...
K231404 · MBI
Healthium Medtech Limited
Orthopedic · 81d
Cleared Aug 02, 2023
Chemfort® Catheter Adaptor
K231286 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 90d
Cleared Aug 01, 2023
Protego Air Water Connector
K231602 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 61d
Cleared Aug 01, 2023
uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy...
K230162 · JAK
Shanghai United Imaging Healthcare...
Radiology · 193d