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
86665–86688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1999
ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST
K983692 · MID
The Binding Site, Ltd.
Immunology · 107d
Cleared Feb 05, 1999
ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT
K983694 · MID
The Binding Site, Ltd.
Immunology · 107d
Cleared Feb 05, 1999
ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT
K983695 · MID
The Binding Site, Ltd.
Immunology · 107d
Cleared Feb 05, 1999
ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT
K983696 · MID
The Binding Site, Ltd.
Immunology · 107d
Cleared Feb 05, 1999
CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000
K984091 · IZH
Trex Medical Corp.
Radiology · 81d
Cleared Feb 05, 1999
PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000
K984092 · IZH
Trex Medical Corp.
Radiology · 81d
Cleared Feb 05, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS...
K984166 · CGN
Ortho-Clinical Diagnostics, Inc.
Chemistry · 77d
Cleared Feb 05, 1999
HOWMEDICA HUMERAL INTERCALARY SYSTEM
K984202 · HSD
Howmedica, Inc.
Orthopedic · 73d
Cleared Feb 05, 1999
ABBOTT ARCHITECT FOLATE
K984301 · CGN
Abbott Laboratories
Chemistry · 65d
Cleared Feb 05, 1999
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005
K984520 · CGR
Nichols Institute Diagnostics
Chemistry · 46d
Cleared Feb 04, 1999
CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS
K972719 · KCT
Medicel, S.A. DE C.V.
General Hospital · 563d
Cleared Feb 04, 1999
NUTRISAFE ENTERAL FEEDING TUBE
K981629 · FPD
Schiff & Co.
Gastroenterology & Urology · 273d
Cleared Feb 04, 1999
DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111
K981733 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 262d
Cleared Feb 04, 1999
DIODE LASER
K982119 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 233d
Cleared Feb 04, 1999
GENICON TROCAR
K982472 · GEA
Genicon, LC
General & Plastic Surgery · 204d
Cleared Feb 04, 1999
PERFUSOR COMPACT
K983005 · FRN
B.Braun Medical, Inc.
General Hospital · 160d
Cleared Feb 04, 1999
UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED)
K983614 · LYY
American Healthcare Products (M) Sdn Bhd
General Hospital · 113d
Cleared Feb 04, 1999
CORE-IDE
K984037 · EBD
Roydent Dental Products, Inc.
Dental · 84d
Cleared Feb 04, 1999
BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
K984053 · JXG
Medtronic PS Medical
Neurology · 90d
Cleared Feb 04, 1999
OSTEO-MESH TM-300
K984230 · JEY
Osteogenics Biomedical, Inc.
Dental · 71d
Cleared Feb 04, 1999
DORNIER MEDILAS R
K984349 · GEX
Dornier
General & Plastic Surgery · 62d
Cleared Feb 04, 1999
MIRACLE MIX POWDER/LIQUID
K984505 · EMA
GC America, Inc.
Dental · 48d
Cleared Feb 04, 1999
SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B
K984561 · FPA
Msr, Inc.
General Hospital · 43d
Cleared Feb 04, 1999
CANDELA GENTLELASE II DERMATOLOGICAL LASER
K984601 · GEX
Candela Corp.
General & Plastic Surgery · 38d