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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
149713–149736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 1985
MUELLER HINTON AGAR
K850715 · JTZ
Rapid City Regional Hospital, Inc.
Microbiology · 28d
Cleared Mar 22, 1985
SELENITE F BROTH
K850716 · JSJ
Rapid City Regional Hospital, Inc.
Microbiology · 28d
Cleared Mar 22, 1985
AMIES TRANSPORT MEDIA
K850717 · JSM
Rapid City Regional Hospital, Inc.
Microbiology · 28d
Cleared Mar 22, 1985
DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR
K850719 · JSH
Rapid City Regional Hospital, Inc.
Microbiology · 28d
Cleared Mar 22, 1985
EOSIN METHYLENE BLUE AGAR, SS AGAR, XLD AGAR 6.5%
K850720 · JSI
Rapid City Regional Hospital, Inc.
Microbiology · 28d
Cleared Mar 22, 1985
KLIGER'S IRON AGAR, SIM MEDIA, MRVP MEDIUM, BILE E
K850721 · JSH
Rapid City Regional Hospital, Inc.
Microbiology · 28d
Cleared Mar 22, 1985
MARTIN LEWIS AGAR
K850722 · JTY
Rapid City Regional Hospital, Inc.
Microbiology · 28d
Cleared Mar 22, 1985
SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC
K850723 · JSI
Rapid City Regional Hospital, Inc.
Microbiology · 28d
Cleared Mar 22, 1985
COBAS FP REAGENTS FOR CARBAMAZEPINE
K850807 · KLT
Roche Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Mar 21, 1985
CUSTOM STERILE PROCEDURE KITS
K842356
Sterile Design, Inc.
General & Plastic Surgery · 279d
Cleared Mar 21, 1985
ACUFEX ARTHROSCOPIC SHAVER
K844130 · HSZ
Acufex Microsurgical, Inc.
Orthopedic · 149d
Cleared Mar 21, 1985
TITERTEK MULTISKAN MCC
K844418 · JJQ
Flow Laboratories, Inc.
Chemistry · 126d
Cleared Mar 21, 1985
TITERTEK MULTISKAN MSS/340
K844419 · JJQ
Flow Laboratories, Inc.
Chemistry · 126d
Cleared Mar 21, 1985
DART DAILY AIR REMOVAL TEST
K844512 · JOJ
American Sterilizer Co.
General Hospital · 121d
Cleared Mar 21, 1985
TITERTEK TWINREADER 78-630-00
K844567 · JJQ
Flow Laboratories, Inc.
Chemistry · 118d
Cleared Mar 21, 1985
BIOSAMPLER
K844615 · CBT
Biotek-Caribbean
Anesthesiology · 114d
Cleared Mar 21, 1985
BASIS DIGITAL THERMOMETER MODEL BTM-1
K844624 · FLL
Terayco Intl., Ltd.
General Hospital · 114d
Cleared Mar 21, 1985
ISIS
K844736 · LDK
Oxford Medilog, Inc.
Physical Medicine · 106d
Cleared Mar 21, 1985
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS
K845032 · DHB
Pharmacia, Inc.
Chemistry · 84d
Cleared Mar 21, 1985
KM PRODUCTS ASPIRATING TUBING
K850105 · BSY
Km Products
Anesthesiology · 69d
Cleared Mar 21, 1985
IN-TH-EAR HEARING AID
K850123 · ESD
General Hearing Instruments, Inc.
Ear, Nose, Throat · 66d
Cleared Mar 21, 1985
CHLAMYDIA FLUORO-KIT 1680
K850158 · LJP
Clinical Sciences, Inc.
Microbiology · 65d
Cleared Mar 21, 1985
CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER
K850384 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 48d
Cleared Mar 21, 1985
STRATOFUSE SYRINGE PIGGYBACK PUMP 1030
K850488 · FRN
Strato Medical Corp.
General Hospital · 42d