FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
138481–138504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 1987
CAVROPUMP
K871129 · DXT
Life-Tech Intl., Inc.
Gastroenterology & Urology · 161d
Cleared Aug 28, 1987
ANNULAR ARRAY SCANHEAD
K871856 · HGL
Advanced Technology Laboratories, Inc.
Obstetrics & Gynecology · 108d
Cleared Aug 28, 1987
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
K872107 · DTZ
Minntech Corp.
Cardiovascular · 80d
Cleared Aug 28, 1987
CURAD MEDICATED PLASTIC STRIPS
K872310 · CGX
The Kendal Co.
Chemistry · 74d
Cleared Aug 28, 1987
EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93
K872321 · DKJ
Em Diagnostic Systems, Inc.
Chemistry · 72d
Cleared Aug 28, 1987
CEDIA DIGOXIN CR ASSAY
K872583 · KXT
Microgenics Corp.
Chemistry · 59d
Cleared Aug 28, 1987
ULTRASCAN IGE ASSAY KIT
K872968 · DGC
Specialty Medical Industries, Inc.
Immunology · 30d
Cleared Aug 28, 1987
TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
K873049 · CDT
Boehringer Mannheim Corp.
Chemistry · 24d
Cleared Aug 28, 1987
TECHNICON H*1 JR.(TM) SYSTEM
K873103 · GKL
Technicon Instruments Corp.
Hematology · 21d
Cleared Aug 28, 1987
MODEL CC-72 CAVERNOSOMETRY/CAVERNOSOGRAPHY SET
K873109 · OJA
Life-Tech Intl., Inc.
Gastroenterology & Urology · 21d
Cleared Aug 27, 1987
CORONARY ARTERY BYPASS GRAFT (CABG) MARKER
K871110 · DSY
Edward Weck, Inc.
Cardiovascular · 161d
Cleared Aug 27, 1987
MODEL 1858 CAVRO/PRESSURE MODULE
K872077 · EXY
Life-Tech Intl., Inc.
Gastroenterology & Urology · 90d
Cleared Aug 27, 1987
BACTIGEN GROUP B STREPTOCOCCUS-CS TEST
K872114 · GTZ
Armkel, LLC
Microbiology · 87d
Cleared Aug 27, 1987
BIOMET MODULAR SHOULDER PROSTHESIS
K872454 · KWT
Biomet, Inc.
Orthopedic · 65d
Cleared Aug 27, 1987
PROTHROMBIN TIME TEST
K872537 · GJS
Sclavo, Inc.
Hematology · 63d
Cleared Aug 27, 1987
MAM-CP X-RAY APPARATUS
K872980 · IZH
Transworld X-Ray Corp.
Radiology · 28d
Cleared Aug 27, 1987
KODAK MIN-R MEDIUM SCREEN
K873167 · EAM
Eastman Kodak Company
Radiology · 16d
Cleared Aug 26, 1987
OPHTHASONIC A-SCAN/ B-SCAN
K871536 · IYO
Teknar, Inc.
Radiology · 128d
Cleared Aug 26, 1987
DISCIPLINE II RTD
K871557 · IKK
Physio Systems, Inc.
Physical Medicine · 126d
Cleared Aug 26, 1987
ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST
K871601 · LCX
Advanced Care Products
Chemistry · 124d
Cleared Aug 26, 1987
FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM
K871846 · KNT
Abbott Laboratories
Gastroenterology & Urology · 106d
Cleared Aug 26, 1987
CENTURION SPECIMEN TRAP W/CATHETER
K872141 · BSY
Tri-State Hospital Supply Corp.
Anesthesiology · 85d
Cleared Aug 26, 1987
KERR CAVALITE
K872147 · EJK
Kerr Corporation (Danbury)
Dental · 83d
Cleared Aug 26, 1987
BILE ACIDS REAGENT
K872296 · KWW
Sigma Diagnostics, Inc.
Chemistry · 71d