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

Filters: Cleared only ×
176,076 results
170809–170832 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 1979
FILTER, EYRPUR DISPOSABLE LEUKOCITE
K781803 · GKT
Metrix Teknika, Inc.
Hematology · 86d
Cleared Jan 17, 1979
REAGENT SYSTEM, INORGANIC PHOSPHORUS
K781806 · CEO
Sigma Chemical Co.
Chemistry · 84d
Cleared Jan 17, 1979
SOLUTION ADMINISTRATION, TIP PROTECTOR
K781813 · FPA
Travenol Laboratories, S.A.
General Hospital · 83d
Cleared Jan 17, 1979
DIALYSATE DELIVERY SYSTEM
K781886 · FKP
Cordis Corp.
Gastroenterology & Urology · 71d
Cleared Jan 17, 1979
PROTHESIS, METACARPAL
K781937
Cutter Laboratories, Inc.
Orthopedic · 58d
Cleared Jan 17, 1979
GLUCOSE OXIDASE REAGENT
K781945 · CGA
Fermco Biochemics, Inc.
Chemistry · 57d
Cleared Jan 17, 1979
BAND AID* ADHESIVE BANDAGES
K782003 · FPX
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 44d
Cleared Jan 17, 1979
CUTTER 888-00 INFUSION PUMP
K782019 · FRN
Sigmamotor, Inc.
General Hospital · 43d
Cleared Jan 17, 1979
INFUSION PUMP, MODEL 5000
K782020 · FRN
Sigmamotor, Inc.
General Hospital · 43d
Cleared Jan 17, 1979
HEMESPEC
K782035 · JJQ
Helena Laboratories
Chemistry · 42d
Cleared Jan 17, 1979
INDICATOR, BIPOLAR TEMPERATURE
K782043 · FLL
Micronex, Inc.
General Hospital · 40d
Cleared Jan 17, 1979
TEST KIT, IIF-ANA
K782048 · DHN
Medica Corp.
Immunology · 40d
Cleared Jan 17, 1979
PROCESSOR, K750 COMPUTER/DATA
K782052 · JQP
Kallestad Laboratories, Inc.
Chemistry · 41d
Cleared Jan 17, 1979
LASER, CO2 SURGICAL
K782054 · HHR
Cavitron Corp.
Obstetrics & Gynecology · 41d
Cleared Jan 17, 1979
HILAR
K782094 · CGX
Hi Chem, Inc.
Pathology · 34d
Cleared Jan 17, 1979
REAGENT, LYSING AND HEMOGLOBIN
K782098 · GGK
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 30d
Cleared Jan 17, 1979
RIA KIT, NEONATAL T4
K782103 · CDX
Serono Laboratories, Inc.
Chemistry · 33d
Cleared Jan 17, 1979
FILTER FOR HYPERALIMENTATION SET
K782134 · FPA
Travenol Laboratories, S.A.
General Hospital · 21d
Cleared Jan 17, 1979
GENERAL EQUIPMENT COVER
K782155 · IZL
Contour Fabricators, Inc.
Radiology · 26d
Cleared Jan 17, 1979
IRMA TEST, NORDICLAB FERRITIN
K782157 · JMG
Nordiclab Intl.
Microbiology · 26d
Cleared Jan 17, 1979
ADMINISTRATION SET, ENEMA
K790005 · FCE
Kelsar Corp.
Gastroenterology & Urology · 15d
Cleared Jan 17, 1979
COUNTER CHECK, H001, H002, H003
K790025 · KSF
Diagnostic Technology, Inc.
Hematology · 14d
Cleared Jan 17, 1979
COUNTER, DISPOSABLE SURGICAL NEEDLE
K790039 · MMK
Anago, Inc.
General Hospital · 9d
Cleared Jan 17, 1979
SPONGES, STANFORD STERILE LAP
K790050 · GDY
Stanford Professional Products
General & Plastic Surgery · 7d