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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
169969–169992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 15, 1979
POST EXTRA SYSTOLIC POTENTIATOR
K781819 · DQO
Medrad, Inc.
Cardiovascular · 80d
Cleared Jan 15, 1979
LEAD, SUTURELESS MYOCARDIAL
K782087 · DTB
Daig Corp.
Cardiovascular · 32d
Cleared Jan 15, 1979
CATHETERS, H-H VENTRICULAR
K782105 · JXG
Holter-Hausner Intl.
Neurology · 27d
Cleared Jan 15, 1979
PULSETAKER
K782131 · DRT
Van, Cott, Bagley, Cornwall & Mccarth
Cardiovascular · 19d
Cleared Jan 15, 1979
DISPOSABLE HOLDER FOR BIOPROSTHESIS
K790022 · DTJ
Edwards Laboratories
Cardiovascular · 12d
Cleared Jan 11, 1979
AUTOMATIC BLOOD PRESSURE DEVICE
K781517 · DXN
Welch Allyn, Inc.
Cardiovascular · 132d