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
123673–123696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 1990
MEASLES IGG MICROASSAY
K903961 · LJB
Diamedix Corp.
Microbiology · 122d
Cleared Dec 28, 1990
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
K904403 · FRN
C.R. Bard, Inc.
General Hospital · 94d
Cleared Dec 28, 1990
GLASSMAN STONE EXTRACTION SET
K904472 · LQR
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Dec 28, 1990
FORCE GSU TM SYSTEM AND FORCE GSU TM HANDSET
K904545 · GEI
Valleylab, Inc.
General & Plastic Surgery · 85d
Cleared Dec 28, 1990
MICROFLO
K904557 · EXY
Life-Tech Intl., Inc.
Gastroenterology & Urology · 84d
Cleared Dec 28, 1990
PALEX IRRIGATION SET
K904586 · EXD
Palex Intl. SA
Gastroenterology & Urology · 80d
Cleared Dec 28, 1990
EUROSUN MODELS - ES-2400, ES-VHO AND ES-16
K904644 · LEJ
Eurosun, Inc.
General & Plastic Surgery · 78d
Cleared Dec 28, 1990
HENNSON INTERNATIONAL DENTAL CAD/CAM SYSTEM
K904927 · ELW
Hennson Intl., Inc.
Dental · 58d
Cleared Dec 28, 1990
BIO-GUARD SHAVE PREP TRAY
K905003 · KME
Network Medical Systems, Inc.
General Hospital · 51d
Cleared Dec 28, 1990
SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE
K905015 · LKY
Surgitek
Gastroenterology & Urology · 51d
Cleared Dec 28, 1990
COAGULATION REFERENCE PLASMA, NORMAL
K905203 · GIZ
Medical Diagnostic Technologies, Inc.
Hematology · 38d
Cleared Dec 28, 1990
MEMORYMATE MODEL 8270 ITE HEARING AID
K905483 · ESD
3M Company
Ear, Nose, Throat · 22d
Cleared Dec 28, 1990
ALKALINE PHOSPHATASE
K905684 · CJE
Amresco, Inc.
Chemistry · 9d
Cleared Dec 27, 1990
FIRST MEDIC MODEL 510
K896903 · LDD
Spacelabs, Inc.
Cardiovascular · 384d
Cleared Dec 27, 1990
NEONATAL VENTILATOR CIRCUIT
K903083 · BZO
Hudson Respiratory Care, Inc.
Anesthesiology · 168d
Cleared Dec 27, 1990
CGA-112 COPING GOLD ALLOY
K903113 · DZE
Minimatic Implant Technology
Dental · 167d
Cleared Dec 27, 1990
ACROMED SACRAL SCREW
K903376 · KWP
Acromed Corp.
Orthopedic · 150d
Cleared Dec 27, 1990
MICRO-MISTER
K903580 · CAF
Bp , Ltd.
Anesthesiology · 141d
Cleared Dec 27, 1990
TEMPORARY DENTAL CEMENT
K904034 · EMA
Medical Device Inspection Co., Inc.
Dental · 118d
Cleared Dec 27, 1990
REFLECTANCE SENSOR (RS-10)
K904039 · DQA
Nellcor, Inc.
Anesthesiology · 114d
Cleared Dec 27, 1990
NEW COBE SATURATION/HEMATOCRIT MONITOR
K904336 · GKF
Cobe Laboratories, Inc.
Hematology · 98d
Cleared Dec 27, 1990
CENTRAL VENOUS PRESSURE MANOMETER
K904674 · KRK
Medex, Inc.
Cardiovascular · 76d
Cleared Dec 27, 1990
THERATEK GROUP EXCHANGE CATHETER
K904680 · MCW
Dow Corning Wright
Cardiovascular · 73d
Cleared Dec 27, 1990
ABUSCREEN ONLINE TM FOR OPIATES
K904997 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 50d