FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
118801–118824 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1991
HAPTOGLOBIN IMMUNOLOGICAL TEST KIT
K913670 · DAB
The Binding Site, Ltd.
Immunology · 112d
Cleared Dec 09, 1991
FUKUDA DENSHI MODEL FCP-4101
K913811 · LOS
Fukuda Denshi USA, Inc.
Cardiovascular · 105d
Cleared Dec 09, 1991
C02 LASER WAVEGUIDE
K913887 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 102d
Cleared Dec 09, 1991
HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT
K913916 · MEH
Smith & Nephew Richards, Inc.
Orthopedic · 97d
Cleared Dec 09, 1991
ESOPHAGEAL Z-STENT
K914029 · ESW
Cook, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 09, 1991
POLLY'S CUTTER J-225
K914038 · HQE
O.R. Specialties, Inc.
Ophthalmic · 90d
Cleared Dec 09, 1991
MIDWEST IMPLANT HEXED 3.3 MM CYLINDER TYPE IMPLANT
K914041 · DZE
Midwest Implant Sales, Inc.
Dental · 90d
Cleared Dec 09, 1991
MIDWEST IMPLANT HEXED 3.75MM SELF TAPPING IMPLANT
K914042 · DZE
Midwest Implant Sales, Inc.
Dental · 90d
Cleared Dec 09, 1991
MIDWEST IMPLANT HEXED 3.75MM STANDARD THREAD IMPLA
K914043 · DZE
Midwest Implant Sales, Inc.
Dental · 90d
Cleared Dec 09, 1991
PEDIATRIC VITRECTOMY LENS SET
K914051 · HJK
Ocular Instruments, Inc.
Ophthalmic · 90d
Cleared Dec 09, 1991
NK GRASP SENSOR, MODEL GR001
K914054 · LBB
Nk Biotechnical Engineering Co.
Neurology · 90d
Cleared Dec 09, 1991
PINCH SENSOR, MODEL PF001
K914055 · LBB
Nk Biotechnical Engineering Co.
Neurology · 90d
Cleared Dec 09, 1991
NK PINCH SENSOR, MODEL PF002
K914056 · LBB
Nk Biotechnical Engineering Co.
Neurology · 90d
Cleared Dec 09, 1991
NK PINCH SENSOR, MODEL PA001
K914057 · LBB
Nk Biotechnical Engineering Co.
Neurology · 90d
Cleared Dec 09, 1991
NK DEVIATION SENSOR, MODEL DV001
K914059 · LBB
Nk Biotechnical Engineering Co.
Neurology · 90d
Cleared Dec 09, 1991
RANGE OF MOTION SENSOR, MODEL RM001
K914060 · KQX
Nk Biotechnical Engineering Co.
Neurology · 90d
Cleared Dec 09, 1991
NK RANGE OF MOTION SENSOR, MODEL RM002
K914061 · KQX
Nk Biotechnical Engineering Co.
Neurology · 90d
Cleared Dec 09, 1991
NK DEXTERITLY BOARD, MODEL BX001
K914062 · KQX
Nk Biotechnical Engineering Co.
Neurology · 90d
Cleared Dec 09, 1991
ULTRACROWN(TM) PRE-SOLDER
K914186 · EJT
Dentsply Intl.
Dental · 82d
Cleared Dec 09, 1991
DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)
K914245 · KGX
Dale Medical Products, Inc.
General & Plastic Surgery · 77d
Cleared Dec 09, 1991
SPECTROLYSE PROTEIN C KIT
K914307 · GGP
Biopool AB
Hematology · 75d
Cleared Dec 09, 1991
TRANSFERRIN RID KIT
K914390 · DDG
The Binding Site, Ltd.
Immunology · 69d
Cleared Dec 09, 1991
ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION
K914458 · LDD
Medical Data Electronics
Cardiovascular · 63d
Cleared Dec 09, 1991
STONE BASKET
K914505 · FFL
Surgitek Medical Engineering Corp.
Gastroenterology & Urology · 61d