FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
95569–95592 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 1997
GENIE PROCESSING AND REVIEW WORKSTATION
K964012 · KPS
GE Medical Systems
Radiology · 92d
Cleared Jan 06, 1997
OXYLOG 2
K954731 · BZL
P.K. Morgan , Ltd.
Anesthesiology · 448d
Cleared Jan 06, 1997
CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT...
K962305 · GKZ
Coulter Corp.
Hematology · 203d
Cleared Jan 06, 1997
CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT...
K962768 · GKZ
Coulter Corp.
Hematology · 203d
Cleared Jan 06, 1997
SERAGARD VASCULAR ACCESS DEVICE
K963595 · FMI
Cutting Edge Technologies, Inc.
General Hospital · 119d
Cleared Jan 06, 1997
MODEL 90022 ROLLING STAND
K963672 · JOW
Augustine Medical, Inc.
Cardiovascular · 115d
Cleared Jan 06, 1997
FIRST MIDCATH CATHETER KIT
K964048 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 89d
Cleared Jan 06, 1997
FIRST MIDCATH CATHETER WITH DUAL LUMENS
K964049 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 89d
Cleared Jan 06, 1997
FIRST MIDCATH CATHETER
K964050 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 89d
Cleared Jan 06, 1997
OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS
K964103 · DWL
Tournier-Bottu S.A.
General Hospital · 87d
Cleared Jan 06, 1997
ARDENT NON GAMMA-2 70
K964192 · EJJ
Ardent Production Development
Dental · 81d
Cleared Jan 06, 1997
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM
K964284 · DTK
Boston Scientific Corp
Cardiovascular · 70d
Cleared Jan 03, 1997
RFA-300, LDA UTILITY
K961400 · IYE
Scanditronix Medical AB
Radiology · 267d
Cleared Jan 03, 1997
N95 FILTERING FACEPIECE
K962443 · FXX
Survivair, Inc.
General Hospital · 193d
Cleared Jan 03, 1997
ROLL BELTS
K963467 · FMQ
Deroyal Industries, Inc.
General Hospital · 122d
Cleared Jan 03, 1997
MICRO21 WITH NDNA
K964165 · DHN
Triangle Biomedical Sciences, Inc.
Immunology · 78d
Cleared Jan 03, 1997
VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH...
K964326 · FAM
Vision-Sciences, Inc.
Gastroenterology & Urology · 65d
Cleared Jan 03, 1997
PORTSMART NEEDLE DE-ACCESS ENCLOSURE
K964559 · LJT
Jireh, Inc.
General Hospital · 51d
Cleared Jan 03, 1997
TZ
K964777 · KNW
Gallini Intl., Inc.
Gastroenterology & Urology · 37d
Cleared Jan 02, 1997
VM PLUS PEAK FLOWMETER
K962074 · BZH
Clement Clarke Intl., Ltd.
Anesthesiology · 219d
Cleared Jan 02, 1997
VINGMED SOUND COLOR FLOW MAPPING SYSTEM
K962662 · IYO
Diasonics, Inc.
Radiology · 178d
Cleared Jan 02, 1997
PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL...
K963255 · JWH
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 136d
Cleared Jan 02, 1997
ACURAY DIGITAL X-RAY
K963403 · EHD
New Image Industries, Inc.
Radiology · 126d
Cleared Jan 02, 1997
IMPRA CARBOFLO EPTFE VASCULAR GRAFT
K964197 · DSY
Impra, Inc.
Cardiovascular · 73d