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
156337–156360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1983
EPCOM VCU-1 VACUUM SYSTEM & CURETTE
K831112 · HHI
Epcom Medical Systems, Inc.
Obstetrics & Gynecology · 86d
Cleared Jun 30, 1983
ALPHA-STIM 2000
K831144 · GZJ
Electromedical Products, Inc.
Neurology · 83d
Cleared Jun 30, 1983
INFUSION CANNULA
K831192 · HMX
Medical Instrument Development...
Ophthalmic · 79d
Cleared Jun 30, 1983
SCLERAL PLUG
K831193 · LXP
Medical Instrument Development...
Ophthalmic · 79d
Cleared Jun 30, 1983
SPECIFIC GRAVITY INSTRUMENT
K831213 · JRE
Iris
Chemistry · 77d
Cleared Jun 30, 1983
FLO-GARD 6100 VOLUMETRIC INFUSION PUMP
K831258 · FRN
Travenol Laboratories, S.A.
General Hospital · 73d
Cleared Jun 30, 1983
AMYLASE REAGENT #88129
K831295 · KHM
Hi Chem, Inc.
Chemistry · 71d
Cleared Jun 30, 1983
ARGYLE DUAL STAGE VENOUS RETURN CATH.
K831332 · DWF
Sherwood Medical Co.
Cardiovascular · 66d
Cleared Jun 30, 1983
MODEL FM5
K831371 · HGM
Sonicaid, Inc.
Obstetrics & Gynecology · 64d
Cleared Jun 30, 1983
DELTON LIGHT CURING PIT & FISSURE
K831380 · EBC
Johnson & Johnson Professionals, Inc.
Dental · 63d
Cleared Jun 30, 1983
HAEMOLYTE SOLUTION
K831409 · KOC
Dialysis Clinic, Inc.
Gastroenterology & Urology · 59d
Cleared Jun 30, 1983
AUDIOMETER MODEL-500
K831431 · EWO
Audimax
Ear, Nose, Throat · 57d
Cleared Jun 30, 1983
ISO-SEP SYSTEM
K831434 · CDP
Berwick Medical Products, Inc.
Chemistry · 57d
Cleared Jun 30, 1983
TOXI-LAB CANNABINOID THC SCREEN
K831456 · DKE
Marion Laboratories, Inc.
Toxicology · 55d
Cleared Jun 30, 1983
FETAL BLOOD SAMPLING KIT #1560
K831459 · HGW
Transidyne General Corp.
Obstetrics & Gynecology · 55d
Cleared Jun 30, 1983
YESONA PLASTER OF PARIS BANDAGE
K831492 · ITG
Watson Phillips Y Cia. Sucs., S.A. DE...
Physical Medicine · 51d
Cleared Jun 30, 1983
DENTURE ADHESIVE SEALS
K831493 · KOT
Johnson & Johnson Professionals, Inc.
Dental · 51d
Cleared Jun 30, 1983
TRI-LEVEL TDM CONTROL & I II III
K831500 · DIF
Ortho Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Jun 30, 1983
AMWA TDA THEOPHYLLINE TEST
K831514 · LER
Miles Laboratories, Inc.
Toxicology · 49d
Cleared Jun 30, 1983
DINAMAP VITAL SIGNS MONITOR #1846
K831515 · DXN
Critikon Company, LLC
Cardiovascular · 49d
Cleared Jun 30, 1983
MODEL TP THERMISTOR PROBE
K831528 · DRF
Scimed Life Systems, Inc.
Cardiovascular · 49d
Cleared Jun 30, 1983
CCS MODEL SJ-103 IMPLANTABLE ATRIAL
K831529 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 49d
Cleared Jun 30, 1983
MAGIC T4 125I RADIOIMMUNOASSAY
K831533 · CDX
Corning Medical & Scientific
Chemistry · 48d
Cleared Jun 30, 1983
E.P.T. PLUS TM
K831535 · JHJ
Warner-Lambert Co.
Chemistry · 48d