FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
133993–134016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 1988
ORTHO OWREN'S BUFFER
K883689 · JPA
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Nov 01, 1988
ORTHO FACTOR X DEFICIENT PLASMA
K883690 · GJT
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Nov 01, 1988
ORTHO FACTOR XI DEFICIENT PLASMA
K883691 · GJT
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Nov 01, 1988
ORTHO FACTOR VII DEFICIENT PLASMA
K883692 · GJT
Ortho Diagnostic Systems, Inc.
Hematology · 64d
Cleared Nov 01, 1988
IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES
K883747 · CFT
Diagnostic Products Corp.
Chemistry · 61d
Cleared Nov 01, 1988
AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)
K883878 · CFT
Amersham Corp.
Chemistry · 49d
Cleared Nov 01, 1988
OMNISOUND(TM) 3000
K883893 · IMG
Physio Technology, Inc.
Physical Medicine · 48d
Cleared Nov 01, 1988
MODIFIED LANDMARK VENOUS ACCESS DEVICE
K884259 · FOZ
Menlo Care, Inc.
General Hospital · 28d
Cleared Nov 01, 1988
IVAC(R) VOLUMETRIC CONTROLLER - MODEL 262
K884307 · LDR
Y
General Hospital · 19d
Cleared Nov 01, 1988
SONY COLOR VIDEO CAMERAS AND ACCESSORIES
K884343 · FWB
Sony Corp. of America
General & Plastic Surgery · 18d
Cleared Nov 01, 1988
PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM
K884357 · KOT
Precision Dynamics Corp.
Microbiology · 15d
Cleared Oct 31, 1988
SIEMENS PACS/I-A
K880690 · IZI
Siemens Gammasonics, Inc.
Radiology · 252d
Cleared Oct 31, 1988
COE PAK AUTO MIX, REGULAR OR HARD SET
K881422 · EMA
Coe Laboratories, Inc.
Dental · 209d
Cleared Oct 31, 1988
MEDITRON ENDOLAV MODEL EL-100
K882048 · KNS
Xylog Corp.
Gastroenterology & Urology · 168d
Cleared Oct 31, 1988
DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT
K882629 · GQG
Bd Becton Dickinson Vacutainer...
Microbiology · 126d
Cleared Oct 31, 1988
ONE-STEP HCG
K882896 · DHA
Wampole Laboratories
Chemistry · 112d
Cleared Oct 31, 1988
PISTON SYRINGE WITH NEEDLE
K883033 · FMF
Select Sources, Inc.
General Hospital · 104d
Cleared Oct 31, 1988
INSULIN SYRINGE
K883078 · FMF
Select Sources, Inc.
General Hospital · 104d
Cleared Oct 31, 1988
FIAGEN RUBELLA IGG
K883182 · LFX
Cyberfluor, Inc.
Microbiology · 95d
Cleared Oct 31, 1988
BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM
K883256 · FNM
Bio Clinic Co.
General Hospital · 90d
Cleared Oct 31, 1988
IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN)
K883267 · CDZ
Diagnostic Products Corp.
Chemistry · 89d
Cleared Oct 31, 1988
PL 20/20 INFANT VISION TESTER
K883337 · HOX
Optimed Technologies, Inc.
Ophthalmic · 83d
Cleared Oct 31, 1988
NATURALYTE MIXER
K883408 · FIN
National Medical Care, Medical...
Gastroenterology & Urology · 81d
Cleared Oct 31, 1988
IMMUNOCCULT-LXI
K883432 · KHE
Intl. Immunoassay Laboratories, Inc.
Hematology · 77d