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
149209–149232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 1985
CHOCOLATE AGAR
K851588 · KZI
Preferred Micro-Media
Microbiology · 14d
Cleared Apr 30, 1985
MUELLER HINTON AGAR & MUELLER HINTON AGAR W/5% SHE
K851589 · JTZ
Preferred Micro-Media
Microbiology · 14d
Cleared Apr 30, 1985
MYCOLOGY AGAR W/ANTIBOTICS
K851590 · JSJ
Preferred Micro-Media
Microbiology · 14d
Cleared Apr 29, 1985
DSL PAP RIA -DSL#3100
K844679 · JFH
Diagnostic Systems Laboratories, Inc.
Chemistry · 150d
Cleared Apr 29, 1985
PTH-RIA
K844735 · CEW
Syncor Intl. Corp.
Chemistry · 146d
Cleared Apr 29, 1985
POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE
K844803 · DTP
Electromedics, Inc.
Cardiovascular · 139d
Cleared Apr 29, 1985
JMS NEEDLES & JMS SYRINGES
K845043 · FMI
Jms Co., Ltd.
General Hospital · 122d
Cleared Apr 29, 1985
UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL
K850029 · BXX
Utah Medical Products, Inc.
Anesthesiology · 115d
Cleared Apr 29, 1985
INTRACARDIAC SUMP 12010
K850385 · DWF
Dlp, Inc.
Cardiovascular · 87d
Cleared Apr 29, 1985
NONINVASIVE ELECTRONIC DIGITAL BP MONITOR EBM-1050
K850476 · DXN
Unisonic Products Corp.
Cardiovascular · 90d
Cleared Apr 29, 1985
NONINVASIVE ELECTRONIC DIGITAL BP MONITOR EBM-2050
K850477 · DXN
Unisonic Products Corp.
Cardiovascular · 90d
Cleared Apr 29, 1985
ARCEE DENTAL POST
K851038 · ELR
Arcee Dental Products Co.
Dental · 46d
Cleared Apr 29, 1985
SUGAR-CHEX
K851042 · JJX
Streck Laboratories, Inc.
Chemistry · 46d
Cleared Apr 29, 1985
SUGAR-CHEX II
K851043 · JJX
Streck Laboratories, Inc.
Chemistry · 46d
Cleared Apr 29, 1985
DOSI FLOW
K851058 · LDR
Leventon, S.A.
General Hospital · 46d
Cleared Apr 29, 1985
TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE
K851148 · JLW
Euro-Diagnostics BV
Chemistry · 39d
Cleared Apr 29, 1985
ABCO TRAY CARE KITS
K851173
Abco Dealers, Inc.
General & Plastic Surgery · 35d
Cleared Apr 29, 1985
PEPSODENT DENTURE CLEANSER-WESTONE FORMULA
K851182 · EFT
Lever Brothers Company, Inc.
Dental · 34d
Cleared Apr 29, 1985
PEPSODENT DENTURE CLEANSER PDP FORMULA
K851183 · EFT
Lever Brothers Company, Inc.
Dental · 34d
Cleared Apr 29, 1985
GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL
K851202 · DAK
Gilford
Immunology · 34d
Cleared Apr 29, 1985
WEST BEND ELECTRIC THERMOMETER
K851224 · FLL
The West Bend Co.
General Hospital · 34d
Cleared Apr 29, 1985
A-JUST TURBIDITY METER
K851234 · JQX
Abbott Laboratories
Microbiology · 34d
Cleared Apr 29, 1985
GEMENI AST-LTS REAGENTS
K851267 · CIT
Electro-Nucleonics Laboratories, Inc.
Chemistry · 31d
Cleared Apr 29, 1985
PROLACTIN SYSTEM BY RIA
K851330 · CFT
American Bioclinical, Inc.
Chemistry · 25d