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
127993–128016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 1990
ACME COATED ORTHODONTIC ARCHWIRE
K895483 · EJF
Acme-Monaco Corp.
Dental · 140d
Cleared Jan 29, 1990
DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466
K895631 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 132d
Cleared Jan 29, 1990
CONNECTION SHIELDS CODES 5C4213 AND 5C4215
K895673 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 131d
Cleared Jan 29, 1990
MODIFIED ELISA FOR CHLAMYDIA
K896032 · LJC
Fairleigh Dickinson Laboratories, Inc.
Chemistry · 105d
Cleared Jan 29, 1990
MODIFIED QUINTON SINGLE LUMEN CATHETER
K896252 · MPB
Quinton, Inc.
Gastroenterology & Urology · 91d
Cleared Jan 29, 1990
INPOUCH-TV POUCH
K896296 · JSN
Biomed Diagnostics, Inc.
Microbiology · 90d
Cleared Jan 29, 1990
QUANTUM HIP STEM
K896325 · JDI
Depuy, Inc.
Orthopedic · 88d
Cleared Jan 29, 1990
PORGES CYTOLOGY BRUSHES
K896425 · FDX
Porges Corp.
Gastroenterology & Urology · 82d
Cleared Jan 29, 1990
PORGES DIATHERMY SNARE
K896507 · KNS
Porges Corp.
Gastroenterology & Urology · 75d
Cleared Jan 29, 1990
MALIS BIPOLAR ELECTROSURGICAL SYSTEM CMC-III
K896541 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 75d
Cleared Jan 29, 1990
EASI-LAV ADULT GASTRIC LAVAGE KIT
K896573 · KDH
Clairson Industries, LLC
Gastroenterology & Urology · 70d
Cleared Jan 29, 1990
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K896965 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 45d
Cleared Jan 29, 1990
REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210)
K900017 · JPK
Helena Laboratories
Hematology · 27d
Cleared Jan 26, 1990
SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283
K882955 · DXN
Kontron Instruments, Inc.
Cardiovascular · 561d
Cleared Jan 26, 1990
PATIENT EXAMINATION GLOVES (LATEX)
K891662 · LYY
Darchet (Usa), Inc.
General Hospital · 312d
Cleared Jan 26, 1990
LATECHNICS LATEX EXAMINATION GLOVES
K892619 · LYY
Ssangyong Corp. (M) Sdn. Bhd.
General Hospital · 291d
Cleared Jan 26, 1990
SLEEPSCAN
K894155 · OLZ
Biologic Systems Corp.
Neurology · 226d
Cleared Jan 26, 1990
POWDER-FREE VINYL EXAMINATION GLOVES
K894686 · LYY
Dynarex Corp.
General Hospital · 185d
Cleared Jan 26, 1990
EXPANSION OF THE CORDIS PTA DILATATION CATHETER
K894899 · LIT
Cordis Corp.
Cardiovascular · 178d
Cleared Jan 26, 1990
WR3500 AND WR3600 SERIES RECORDERS
K894922 · DSF
Western Graphtec
Cardiovascular · 177d
Cleared Jan 26, 1990
TYPE 9541 RECORDER, PAPER CHART
K895111 · DSF
S & W Medico Teknik
Cardiovascular · 176d
Cleared Jan 26, 1990
AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED
K895266 · DSI
Biosensor Corp.
Cardiovascular · 156d
Cleared Jan 26, 1990
MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER
K895525 · DRL
Matrix Medica, Inc.
Cardiovascular · 136d
Cleared Jan 26, 1990
LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER
K895533 · LDD
Matrix Medica, Inc.
Cardiovascular · 135d