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
157681–157704 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1983
AIRWAYS & NASOPHARYNGEAL TYPE
K830983 · BTQ
Medovations, Inc.
Anesthesiology · 41d
Cleared May 09, 1983
HEAD STRAP
K831008 · BTK
Medovations, Inc.
Anesthesiology · 40d
Cleared May 09, 1983
BUFFER PACK FOR ABL-1 & ABL-2
K831017 · CHL
Fisher Scientific Co., LLC
Chemistry · 40d
Cleared May 09, 1983
FLUSH SOLUTION CONCENTRATE
K831020 · CHL
Fisher Scientific Co., LLC
Chemistry · 40d
Cleared May 09, 1983
TI-1000 TRANSPORT INCUBATOR
K831028 · FPL
Narco Scientific
General Hospital · 40d
Cleared May 09, 1983
COBAS STANDARDS FOR GLUCOSE & BUN
K831030 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 40d
Cleared May 09, 1983
AIR BURBINE HANDPIECE-DENTAL SCALING
K831037 · ELB
Taco Dental, Inc.
Dental · 39d
Cleared May 09, 1983
PHASE II T3 RADIOIMMUNOASSAY KIT
K831064 · CDP
Medical & Scientific Designs, Inc.
Chemistry · 35d
Cleared May 09, 1983
CONTAINER SYSTEM
K831068
Adler Instrument Co.
General & Plastic Surgery · 35d
Cleared May 09, 1983
CONNECTING TUBING
K831082 · BYX
The Kendall Company Div. of Tyco...
Anesthesiology · 35d
Cleared May 09, 1983
TENZCARE MUSCLE STIMULATION ELECTRODES
K831104 · GXY
3M Company
Neurology · 34d
Cleared May 09, 1983
LUO CURRETTES #3211
K831119 · FZS
Pmt, Inc.
General & Plastic Surgery · 34d
Cleared May 09, 1983
BIOCULT - GC CULTURE-PADDLES
K831124 · JTY
Orion Diagnostica, Inc.
Microbiology · 34d
Cleared May 09, 1983
CEFAXOLIN 30 MCG SENSI-DISC
K831153 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 31d
Cleared May 09, 1983
BLOOD CARDIOPLEGIA STAINLESS STEEL COOL
K831157 · DTR
American Bentley
Cardiovascular · 31d
Cleared May 09, 1983
LEAD ADAPTERS #'S 6016,6022,6017 ETC
K831160 · DTD
Cardiac Pacemakers, Inc.
Cardiovascular · 28d
Cleared May 09, 1983
ENERGETIC HI-HUM AERSOL UNIT
K831162 · CAF
Energetic Pulmonary
Anesthesiology · 28d
Cleared May 09, 1983
ENTERAL PUMP SET
K831167 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 28d
Cleared May 09, 1983
ENTERAL DELIVERY SET
K831168 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 28d
Cleared May 09, 1983
CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP
K831179 · JTN
General Diagnostics
Microbiology · 28d
Cleared May 09, 1983
CARDIO DATA PACEMAKER RECORDER
K831184 · DSH
Cardio Data
Cardiovascular · 28d
Cleared May 09, 1983
RAPID NFT
K831186 · JSN
Dms Laboratories
Microbiology · 27d
Cleared May 09, 1983
TRP
K831187 · JTO
Dms Laboratories
Microbiology · 27d
Cleared May 09, 1983
CONNECTOR TUBE
K831188 · DOY
Medrad, Inc.
Toxicology · 27d