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
157177–157200 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1983
SPORIDIDIN-D COLD STERILIZING/SOLUTION
K830722 · LIF
Sporicidin Intl.
Gastroenterology & Urology · 114d
Cleared Jun 30, 1983
PORT-A-CATH IMPLANTABLE CATH. SYS
K830730 · LJT
Pharmacia, Inc.
General Hospital · 114d
Cleared Jun 30, 1983
CUSTOM IN-THE-EAR HEARING AID
K830960 · ESD
Finetone Hearing Instruments
Ear, Nose, Throat · 97d
Cleared Jun 30, 1983
QUINIDINE REAGENT TEST KIT
K830963 · LBZ
Beckman Instruments, Inc.
Chemistry · 94d
Cleared Jun 30, 1983
HERPES SIMPLEX VIRUS TYPING REAGENTS
K830971 · GQL
Immulok, Inc.
Microbiology · 94d
Cleared Jun 30, 1983
SUN PHOTO-KERATOSCOPE
K831084 · HLQ
Nidek, Inc.
Ophthalmic · 87d
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