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"
265–288 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 19, 2025
Visby Medical Respiratory Health Test
K242526 · QOF
Visby Medical, Inc.
Microbiology · 177d
Cleared Feb 12, 2025
Electrically Powered Wheelchair
K243962 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 51d
Cleared Feb 12, 2025
Electrically Powered Wheelchair
K243961 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 51d
Cleared Feb 12, 2025
AspenView
K241425 · LLZ
Aspen Imaging Healthcare, Inc.
Radiology · 268d
Cleared Feb 11, 2025
Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02,...
K243155 · FGB
Dongguan Zsr Biomedical Technology...
Gastroenterology & Urology · 134d
Cleared Feb 10, 2025
Philips Lumea IPL
K243453 · OHT
Philips Consumer Lifestyle B.V.
General & Plastic Surgery · 95d
Cleared Feb 03, 2025
iCare APP
K243146 · MWI
Ihealth Labs, Inc.
Cardiovascular · 126d
Cleared Feb 03, 2025
Sonicaid Team3
K241368 · HGM
Huntleigh Healthcare , Ltd.
Obstetrics & Gynecology · 265d
Cleared Jan 27, 2025
Bunkerhill AVC
K243229 · JAK
BunkerHill Health
Radiology · 111d
Cleared Jan 27, 2025
Imaging system of positron emission and X-ray computed tomography (DigitMI 930)
K241266 · KPS
Raysolution Healthcare Co., Ltd.
Radiology · 266d
Cleared Jan 23, 2025
MONARCH™ Platform (MON-000008)
K243219 · EOQ
Auris Health, Inc.
Ear, Nose, Throat · 108d
Cleared Jan 22, 2025
Suture-TOOL System
K242835 · NEW
Suturion AB
General & Plastic Surgery · 125d
Cleared Jan 22, 2025
Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3,...
K241956 · FGB
Hunan Endoso Life Technology Co., Ltd.
Gastroenterology & Urology · 203d
Cleared Jan 16, 2025
Cala kIQ
K243848 · QBC
Cala Health, Inc.
Neurology · 31d
Cleared Jan 15, 2025
Cardiac Guidance
K243065 · QJU
Caption Health, Inc.
Radiology · 110d
Cleared Jan 14, 2025
uCT 550
K241166 · JAK
Shanghai United Imaging Healthcare...
Radiology · 263d
Cleared Jan 13, 2025
Sterilized Eol Auto Lancet
K243533 · FMK
Hlb Co., Ltd. Healthcare
General & Plastic Surgery · 59d
Cleared Jan 13, 2025
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L,...
K241431 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 237d
Cleared Jan 08, 2025
ANNE View, Central Hub
K242842 · MSX
Sibel Health, Inc.
Cardiovascular · 111d
Cleared Jan 08, 2025
HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
K241003 · NHA
Hiossen, Inc.
Dental · 271d
Cleared Jan 07, 2025
GlutenID Celiac Genetic Health Risk Test
K241456 · PTA
Targeted Genomics, LLC
Immunology · 230d
Cleared Jan 07, 2025
uCT 780
K241079 · JAK
Shanghai United Imaging Healthcare...
Radiology · 263d
Cleared Jan 03, 2025
Clarify DL
K241350 · LLZ
Ge Medical Systems Israel, Functional...
Radiology · 235d
Cleared Dec 27, 2024
OEC One ASD
K240828 · OXO
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 276d