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
163321–163344 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1981
PARA 1 SENDAI HEMAGGLUTININ
K812365 · GQR
Dutchland Laboratories, Inc.
Microbiology · 20d
Cleared Sep 09, 1981
GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD)
K812367 · LHT
Dutchland Laboratories, Inc.
Immunology · 20d
Cleared Sep 09, 1981
RAT BLOOD IN ALSEVER'S, CITRATED
K812368 · LHT
Dutchland Laboratories, Inc.
Microbiology · 20d
Cleared Sep 09, 1981
GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF
K812372 · LHT
Dutchland Laboratories, Inc.
Immunology · 20d
Cleared Sep 09, 1981
RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR
K812373 · LHT
Dutchland Laboratories, Inc.
Immunology · 20d
Cleared Sep 09, 1981
ADULT CHICKEN BLOOD IN ALSEVER'S, C., D.
K812374 · LHT
Dutchland Laboratories, Inc.
Immunology · 20d
Cleared Sep 09, 1981
BABY CHICK BLOOD IN ALSEVER'S
K812375 · LHT
Dutchland Laboratories, Inc.
Immunology · 20d
Cleared Sep 09, 1981
SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBR
K812376 · LHT
Dutchland Laboratories, Inc.
Immunology · 20d
Cleared Sep 09, 1981
DIGITRON ELECTRONIC THERMOMETERS - 4700
K812387 · FLL
Ercona Corp.
General Hospital · 20d
Cleared Sep 09, 1981
UNSCENTED MENSTRUAL PADS
K812402 · HHD
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 20d
Cleared Sep 09, 1981
SCENTED MENSTRUAL PADS
K812403 · HHL
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 20d
Cleared Sep 09, 1981
BUTTERFLY NEEDLE ASSEMBLY
K812404 · FMI
Nu Tech Medical Systems
General Hospital · 20d
Cleared Sep 09, 1981
KALLESTAD ANTISERA TO TOBRAMYCIN
K812415 · KLB
Kallestad Laboratories, Inc.
Microbiology · 9d
Cleared Sep 09, 1981
BLOOD UREA NITROGEN(BUN-UV)
K812417 · CDQ
Reagents Applications, Inc.
Chemistry · 16d
Cleared Sep 09, 1981
URIC ACID REAGENT SET
K812430 · KNK
Pointe Scientific, Inc.,
Chemistry · 15d
Cleared Sep 09, 1981
AMYLASE REAGENT KIT
K812447 · KHM
Bioscientific
Chemistry · 12d
Cleared Sep 09, 1981
ALKALINE PHOSPHATASE
K812452 · CJE
Pointe Scientific, Inc.,
Chemistry · 12d
Cleared Sep 08, 1981
SCOPE MASTER
K811270 · HIH
Synemed, Inc.
Obstetrics & Gynecology · 125d
Cleared Sep 08, 1981
DYNA- MO
K811629 · IYX
Philips Medical Systems (Cleveland),...
Radiology · 91d
Cleared Sep 08, 1981
MULTI-PURPOSE DENTAL SYRINGE
K811831 · EJI
Centrix, Inc.
Dental · 71d
Cleared Sep 08, 1981
MEDISYSTEMS FISTULA NEEDLE
K811838 · FIE
Medisystems Corp.
Gastroenterology & Urology · 69d
Cleared Sep 08, 1981
MEDISYSTEM NEGATIVE PRESSURE
K811839 · FJK
Medisystems Corp.
Gastroenterology & Urology · 69d
Cleared Sep 08, 1981
MODEL SIX BEAM SYSTEM
K811848 · GWF
Braintech, Inc.
Neurology · 69d
Cleared Sep 08, 1981
NOVAMETRIX PHYSIOLOGICAL MONITOR #910
K811893 · DRT
Novametrix Medical Systems, Inc.
Cardiovascular · 69d