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
156025–156048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 1983
EDSLAB PRESSURE GAUGE
K832323 · MAV
American Edwards Laboratories
Cardiovascular · 27d
Cleared Aug 10, 1983
UNIVERSAL CORONARY CANNULA
K831330 · DWF
Possis Medical, Inc.
Cardiovascular · 107d
Cleared Aug 10, 1983
STAT-TRAK LIQUID ELECTROLYTE CONTROL
K831389 · JJR
United Diagnostics, Inc.
Chemistry · 103d
Cleared Aug 10, 1983
FOLEY-TEMP
K831567 · KOD
Mallinckrodt Critical Care
Gastroenterology & Urology · 86d
Cleared Aug 10, 1983
AQUEOUS BLOOD GAS CONTROL LEVEL I,II &
K832003 · JJS
American Dade
Chemistry · 49d
Cleared Aug 08, 1983
INJECTION SEALING CAP 13791
K830541 · FOZ
Quinton, Inc.
General Hospital · 167d
Cleared Aug 08, 1983
MEDION MI-200 IONTOPHORETIC MEDICATOR
K831000
Etherington Industries
Dental · 132d
Cleared Aug 08, 1983
QUANTIGEN T & B CELL ASSAY
K831053 · LIZ
Bio-Rad
Chemistry · 129d
Cleared Aug 08, 1983
COMPUDIAL/KP-1
K831132 · LIF
Computer Dialysis Systems, Inc.
Gastroenterology & Urology · 124d
Cleared Aug 08, 1983
CMV RQ BIO-ENZABEAD KIT
K831343 · LFZ
Litton Bionetics
Immunology · 105d
Cleared Aug 08, 1983
PRESSURE MONITOR & CONTROL UNIT APC-02A
K831402 · KXM
Parker Hannifin Corp.
Gastroenterology & Urology · 98d
Cleared Aug 08, 1983
AUTO SUTURE POLY SURGICLIP HEMOSTATIC
K831457 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 94d
Cleared Aug 08, 1983
ALLERGEN IMMUNOSORBENTS IP SPECIFIC E
K831496
Diagnostic Reagent Tech.
Immunology · 90d
Cleared Aug 08, 1983
WASHER 6000 MICRO-C LISA SYSTEM
K831640 · JTC
Organon Teknika Corp.
Chemistry · 77d
Cleared Aug 08, 1983
AMS MALLEABLE PENILE PROSTHESIS
K831660 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 77d
Cleared Aug 08, 1983
LEGIONELLA IFA KIT I
K831760 · LHL
Bionetic Laboratory Products
Toxicology · 68d
Cleared Aug 08, 1983
URINE BAG SYSTEM
K831796 · KNX
I M, Inc.
Gastroenterology & Urology · 66d
Cleared Aug 08, 1983
PNEUMATIC/ELECTRIC/HYDRAULIC BED
K831821 · FNL
G.W. Healthcare, Inc.
General Hospital · 63d
Cleared Aug 08, 1983
ENTERNAL PUMP & ADMIN. SET 430
K831935 · FRN
Imed Corp.
General Hospital · 54d
Cleared Aug 08, 1983
GAMMA STERILIZED CAPILLARY FLOW DIALYZ
K831940 · FKQ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 53d
Cleared Aug 08, 1983
DATA-ZYME URIC ACID PROCEDURE
K831983 · KNK
Data Medical Associates, Inc.
Chemistry · 49d
Cleared Aug 08, 1983
METAL-BACKED ACE TABULAR CUP
K831986 · JDI
Kirschner Medical Corp.
Orthopedic · 49d
Cleared Aug 08, 1983
VISIDEX II REAGENT STRIPS
K831989 · CGA
Miles Laboratories, Inc.
Toxicology · 48d
Cleared Aug 08, 1983
BIOCHECK POSITIVE URINE CONTROL
K831994 · JJW
Helena Laboratories
Chemistry · 48d