Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
165385–165408 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1981
AUTOMATED IMMUNOPRECIPITIN METHOD/IGA
K803274 · CZP
Icl Scientific
Immunology · 28d
Cleared Jan 26, 1981
ANA-IFA TEST SYSTEM
K803276 · DHN
Immuno Concepts, Inc.
Immunology · 28d
Cleared Jan 26, 1981
STERILE DISPOSABLE INSTRUMENT TRAYS
K810004 · FSM
Ascep, Inc.
General & Plastic Surgery · 20d
Cleared Jan 26, 1981
SRD III
K810022 · JTC
Dynatech Corp.
Chemistry · 21d
Cleared Jan 26, 1981
BI-CENTRIC BI-POLAR ENDOPROSTHESIS
K810062 · KWY
Howmedica Corp.
Orthopedic · 13d
Cleared Jan 26, 1981
AUTOMATIC BIOCHEMICAL ANALYZER
K810063 · JQP
Acculab
Chemistry · 13d
Cleared Jan 26, 1981
PULSARII, HIGH VOLT. GALVANIC MUSC. STIM
K810064 · IPF
Bomed Medical Mfr., Ltd.
Physical Medicine · 13d
Cleared Jan 26, 1981
ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT
K810082 · CJE
Bio-Analytics Laboratories, Inc.
Chemistry · 13d
Cleared Jan 26, 1981
MAGNESIUM KIT
K810084 · JGJ
Bio-Analytics Laboratories, Inc.
Chemistry · 13d
Cleared Jan 26, 1981
6% ORTHO LOLIUDINE REAGENT IN GLACID ACI
K810089 · CGE
Anco Medical Reagents & Assoc.
Chemistry · 13d
Cleared Jan 26, 1981
CHOLESTEROL REAGENT
K810090 · CGO
Anco Medical Reagents & Assoc.
Chemistry · 13d
Cleared Jan 26, 1981
GLUCOSE STANDARD
K810091 · JIS
Anco Medical Reagents & Assoc.
Chemistry · 13d
Cleared Jan 26, 1981
RESPA-TROL
K810107 · JJS
Intensive Technology, Inc.
Chemistry · 10d
Cleared Jan 26, 1981
METAL SPLINTS
K810109 · ILH
Secol Co.
Physical Medicine · 10d
Cleared Jan 26, 1981
COBBLER'S CHIP SPLINTS
K810110 · LGF
Secol Co.
Orthopedic · 10d
Cleared Jan 23, 1981
VISECERA RETAINER
K802806 · GCZ
Adept-Med Intl., Inc.
General & Plastic Surgery · 77d
Cleared Jan 23, 1981
ERECTAID
K803111 · FAE
Burditt & Calkins-Siemens-Elema
Gastroenterology & Urology · 44d
Cleared Jan 23, 1981
PROSTHESIS, HIP FEMORAL COMPONENT METAL
K803191 · KWL
Osteonics Corp.
Orthopedic · 38d
Cleared Jan 23, 1981
HCL ACETABULAR COMPONENTS
K803192 · KWZ
Osteonics Corp.
Orthopedic · 38d
Cleared Jan 23, 1981
SURG-FLEX 5 SURGICAL LIGHT
K810018 · FSQ
Medical Products Development, Inc.
General & Plastic Surgery · 18d
Cleared Jan 23, 1981
SURG-FLEX 15 SURGICAL LIGHT
K810019 · FSQ
Medical Products Development, Inc.
General & Plastic Surgery · 18d
Cleared Jan 23, 1981
FLO-TEMP
K810021 · FLA
Laminar Flow Industries
Gastroenterology & Urology · 18d
Cleared Jan 23, 1981
BONNER BRACE
K810024 · IQK
Bee Ent.
Physical Medicine · 18d
Cleared Jan 23, 1981
PRENATAL SUPPORT PILLOW
K810035 · CCX
Supportech, Inc.
Anesthesiology · 14d