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
164761–164784 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 1981
SQUINN VITATEK 500 SERIES PHYSIOL. MONI
K810755 · DRT
Vitatek
Cardiovascular · 14d
Cleared Apr 03, 1981
API TURBICITY STANDARD
K810762 · JKP
Analytical Products, Inc.
Chemistry · 11d
Cleared Apr 03, 1981
QUANTIMUNE FERRITIN IRMA
K810799 · JMG
Bio-Rad
Chemistry · 11d
Cleared Apr 03, 1981
CARDIOPULMONARY BYPASS
K810820 · DWF
Dlp, Inc.
Cardiovascular · 10d
Cleared Apr 03, 1981
NEONATAL BLOOD PRESSURE CUFF
K810838 · DXQ
Invivo Research Labs, Inc.
Cardiovascular · 7d
Cleared Apr 02, 1981
VASCULAR TIE (VAS-TIE)
K810080 · KDC
Sil-Med Corp.
General & Plastic Surgery · 79d
Cleared Apr 02, 1981
MODEL 1301 BIOTAC (TM)
K810627 · GEA
Progress Mankind Technology
General & Plastic Surgery · 24d
Cleared Apr 01, 1981
INTERMEDICS CYBERLITH I BIOPOLAR CARDI
K810383 · DXY
Intermedics, Inc.
Cardiovascular · 47d
Cleared Apr 01, 1981
CYBERLITH I PULSE GENERATOR MODEL 253-04
K810385 · DXY
Intermedics, Inc.
Cardiovascular · 47d
Cleared Apr 01, 1981
STOCK ANTIMICROBIC SOLUTIONS
K810471 · LOP
Cathra International, Inc.
Microbiology · 37d
Cleared Apr 01, 1981
SIEMENS MODEL 146-146A EXTERNAL PULSE G
K810566 · DTE
Cynergy
Cardiovascular · 29d
Cleared Apr 01, 1981
REPLICA PLATER
K810719 · JTC
Dynatech Corp.
Hematology · 15d
Cleared Apr 01, 1981
A-GENT UREA NITROGEN
K810794 · CDQ
Abbott Laboratories
Chemistry · 9d
Cleared Apr 01, 1981
PROGESTERONE KIT
K810804 · JLS
Cambridge Nuclear Corp.
Chemistry · 8d
Cleared Mar 31, 1981
HAEMONETICS 1400 ML THERAPEUTIC BAG
K810313 · KSR
Haemonetics Corp.
Hematology · 54d
Cleared Mar 31, 1981
BOSCH STAR 66F SUPER EARLEVEL AID
K810347 · ESD
Bosch Hearing Instruments, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 31, 1981
HAEMONETICS 170 Y INFUSION SET
K810365 · FPA
Haemonetics Corp.
General Hospital · 47d
Cleared Mar 31, 1981
OESOPHAGEAL THERAPY KIT
K810392 · KNT
Keymed, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 31, 1981
CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP.
K810427 · JTN
Pfizer Pharmaceuticals
Microbiology · 41d
Cleared Mar 31, 1981
PROBE COVER
K810474 · FLL
Narco Air-Shields
General Hospital · 36d
Cleared Mar 31, 1981
MODEL EM-IR
K810528 · KZM
Myo-Tronics Research, Inc.
Dental · 33d
Cleared Mar 31, 1981
CEFOTAXIME 30 MCG. SENSITIVITY DISCS.
K810546 · JTN
Difco Laboratories, Inc.
Immunology · 32d
Cleared Mar 31, 1981
CEFOTAXIME 30 MCG. SENSI-DISC.
K810564 · JTN
Bd Becton Dickinson Vacutainer...
Toxicology · 28d
Cleared Mar 31, 1981
POWER SONIC
K810577 · ESD
Qualitone
Ear, Nose, Throat · 28d