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
130441–130464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1989
LATEX EXAMINATION GLOVES
K893264 · LYY
P.T. Kreasi Bhojwanis
General Hospital · 78d
Cleared Aug 03, 1989
MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE
K893403 · LDD
Hewlett-Packard Co.
Cardiovascular · 94d
Cleared Aug 03, 1989
INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM
K893404 · CGA
Apprise, Inc.
Chemistry · 93d
Cleared Aug 03, 1989
COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)
K893419 · DEW
Coulter Immunology
Microbiology · 93d
Cleared Aug 03, 1989
SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE
K893470 · DQA
Siemens Medical Electronics
Anesthesiology · 91d
Cleared Aug 03, 1989
CLINIMATE-TDA BLOOD CHEMISTRY ANALYZER
K893547 · JJE
Heraeus Kulzer, Inc.
Chemistry · 87d
Cleared Aug 03, 1989
SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP
K893548 · LBS
Heraeus Kulzer, Inc.
Chemistry · 87d
Cleared Aug 03, 1989
STATUS HCG FLUOROMETRIC ENZYME
K893577 · DHA
Baxter Healthcare Corp
Chemistry · 86d
Cleared Aug 03, 1989
GAMMA LOCKING NAIL
K893639 · KTT
Howmedica Corp.
Orthopedic · 83d
Cleared Aug 03, 1989
PERCUTANEOUS INTRODUCER
K893658 · DYB
Medamicus, Inc.
Cardiovascular · 80d
Cleared Aug 03, 1989
SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM
K893683 · DTL
3M Company
Cardiovascular · 79d
Cleared Aug 03, 1989
ETHICON DISPOSABLE SURGICAL TROCAR
K893715 · HET
Ethicon, Inc.
Obstetrics & Gynecology · 77d
Cleared Aug 03, 1989
ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER
K893776 · JJE
Abbott Laboratories
Chemistry · 73d
Cleared Aug 03, 1989
IMMUNO-WASH AUTOMATED TUBE WASHER
K893810 · JQW
Ocean Scientific, Inc.
Chemistry · 73d
Cleared Aug 03, 1989
COBAS FARA II CENTRIFUGAL ANALYZER
K893854 · JJG
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES
K893855 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE
K893856 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE
K893857 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC
K893858 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE
K893859 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE
K893860 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE)
K893869 · GAD
Adept-Med Intl., Inc.
General & Plastic Surgery · 69d
Cleared Aug 03, 1989
GOOTT BALFOUR BLADE
K893871 · GAD
Adept-Med Intl., Inc.
General & Plastic Surgery · 69d
Cleared Aug 03, 1989
PRIMAPORE I.V.
K893900 · KGX
Smith & Nephew United, Inc.
General & Plastic Surgery · 48d