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

Filters: Cleared only ×
176,076 results
159721–159744 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1982
SERIES 7000 BEDSIDE PATIENT MONITOR
K822718 · DSI
Marquette Electronics, Inc.
Cardiovascular · 27d
Cleared Oct 04, 1982
EAR/ULCER SYRINGE
K822754 · KCP
American Hospital Supply Corp.
Ear, Nose, Throat · 26d
Cleared Oct 04, 1982
ELECTROCARDIOGRAPH (74 DPS) #YM-102
K822768 · DPS
Sanyo Electric, Inc.
Cardiovascular · 20d
Cleared Oct 04, 1982
PHONIC EAR-PE 845-PPC
K822779 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 20d
Cleared Oct 04, 1982
DISSCAP 080
K822851 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 10d
Cleared Oct 04, 1982
ULTRA IMAGER
K827408
Honeywell, Inc.
Radiology · 68d
Cleared Sep 30, 1982
FERMCOTEST CO2 REAGNET
K822117 · JFL
Fermco Biochemics, Inc.
Chemistry · 73d
Cleared Sep 30, 1982
FERMCOTEST CREATININE TEST REAGENT
K822118 · CGX
Fermco Biochemics, Inc.
Chemistry · 73d
Cleared Sep 30, 1982
ACA URINARY PROTEIN ANALYTICAL TEST PACK
K822231 · JGQ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 65d
Cleared Sep 30, 1982
DSL 1400
K822314 · CGI
Diagnostic Systems Laboratories, Inc.
Chemistry · 58d
Cleared Sep 30, 1982
BOSTON SOLUTION INFUSION SETS
K822406 · FPA
The Boston Medical Group
General Hospital · 51d
Cleared Sep 30, 1982
BOSTON SCALP VEIN INFUSION SETS
K822407 · FPA
The Boston Medical Group
General Hospital · 51d
Cleared Sep 30, 1982
BOSTON INFUSION SETS
K822408 · FPA
The Boston Medical Group
General Hospital · 51d
Cleared Sep 30, 1982
BOSTON BLOOD TRANSFUSION SETS
K822409 · BRZ
The Boston Medical Group
General Hospital · 51d
Cleared Sep 30, 1982
BOSTON BLOOD DONOR SETS
K822410 · BRZ
The Boston Medical Group
General Hospital · 51d
Cleared Sep 30, 1982
ANTISERA TO HUMAN FERRITIN
K822472 · DBF
Kent Laboratories, Inc.
Microbiology · 44d
Cleared Sep 30, 1982
INFECTION CONTROL TOWEL
K822484 · LDQ
American Threshold Industries, Inc.
General & Plastic Surgery · 44d
Cleared Sep 30, 1982
LE CASE HARD CONTACT LENS STORAGE CASE
K822495 · HPX
Optikem International, Inc.
Ophthalmic · 43d
Cleared Sep 30, 1982
OBSTETRICAL KIT
K822505 · HHD
Parr Emergency Product Sales, Inc.
Obstetrics & Gynecology · 43d
Cleared Sep 30, 1982
AUTOMATED BLOOD CELL SEPARATOR
K822521 · GKT
Cryosan, Inc.
Hematology · 38d
Cleared Sep 30, 1982
ANAEROBE PEA PLATE
K822527 · JSJ
Granite Diagnostics, Inc.
Microbiology · 38d
Cleared Sep 30, 1982
CIDEX*DIALYZER DISINFECTING SOLUTION
K822535 · FKQ
Surgikos, Inc.
Chemistry · 37d
Cleared Sep 30, 1982
LEECO T3% DIAGNOSTIC KIT
K822575 · KHQ
Leeco Diagnostics, Inc.
Chemistry · 36d
Cleared Sep 30, 1982
BOSCH STAR 66F-SP HEARING AID
K822579 · ESD
Bosch Hearing Instruments, Inc.
Ear, Nose, Throat · 36d