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

Filters: Cleared only ×
175,820 results
121801–121824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 1991
VZVSCAN(TM) LATEX AGGUTINATION TEST
K912239 · GQW
Bd Becton Dickinson Vacutainer...
Microbiology · 21d
Cleared Jun 10, 1991
BABYLOG 8000 INFANT VENTILATOR
K903089 · CBK
Drager, Inc.
Anesthesiology · 332d
Cleared Jun 10, 1991
SYSTEM 70 AND 100
K904246 · ITI
Folio Products, Inc.
Physical Medicine · 269d
Cleared Jun 10, 1991
SYSTEM 50
K905292 · ITI
Folio Products, Inc.
Physical Medicine · 199d
Cleared Jun 10, 1991
ABUTMENT GLO
K905303 · EJR
Implant Innovations International, Inc.
Dental · 194d
Cleared Jun 10, 1991
EIA FOR DETECTION OF ANTIBODIES H. PYLORI
K905409 · LYR
E-Z-Em, Inc.
Microbiology · 189d
Cleared Jun 10, 1991
MYOCARDIAL PROTECTION SYSTEM
K905500 · DTR
Medtronic Vascular
Cardiovascular · 185d
Cleared Jun 10, 1991
QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER
K905753 · KGI
Hologic, Inc.
Radiology · 168d
Cleared Jun 10, 1991
COLLAGEN SHIELD, VARIOUS MODELS
K905825 · MOE
Chiron Ophthalmics
Ophthalmic · 161d
Cleared Jun 10, 1991
BROWNE MEDICAL SYSTEMS IMAGEPRO
K910444 · FAP
Browne Medical Systems, Inc.
Gastroenterology & Urology · 131d
Cleared Jun 10, 1991
CARD GUARD, MODEL CG-2000A
K910451 · DXH
Medtech Industries, Inc.
Cardiovascular · 129d
Cleared Jun 10, 1991
RADIOACTIVE SEEDS
K910710 · KXK
Best Assoc. Corp.
Radiology · 110d
Cleared Jun 10, 1991
BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER
K910720 · FCG
C.R. Bard, Inc.
Gastroenterology & Urology · 110d
Cleared Jun 10, 1991
LYME DISEASE MICROASSAY
K910899 · LSR
Diamedix Corp.
Microbiology · 105d
Cleared Jun 10, 1991
TURBIDOMETRIC STANDARD
K911059 · LIE
Scientific Device Laboratory, Inc.
Microbiology · 91d
Cleared Jun 10, 1991
DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES
K911091 · FAP
Diagnostic Ultrasound Corp.
Gastroenterology & Urology · 90d
Cleared Jun 10, 1991
SONARSCAN 128 ULTRASOUND SCANNER
K911107 · IYO
Diagnostic Sonar USA
Radiology · 90d
Cleared Jun 10, 1991
DEVICE PART NUMBERS: - 1400 SERIES
K911112 · DZE
Minimatic Implant Technology
Dental · 117d
Cleared Jun 10, 1991
PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR
K911191 · DQA
Palco Laboratories, Inc.
Anesthesiology · 84d
Cleared Jun 10, 1991
SCHNEIDER TOTAL CROSS .021 PERCU TRANS ANGIO (PTA)
K911196 · LIT
Schneider Intl., Ltd.
Cardiovascular · 84d
Cleared Jun 10, 1991
PULPDENT SEAL RITE
K911287 · EBC
Pulpdent Corp.
Dental · 83d
Cleared Jun 10, 1991
ULTRASET CATHETER
K911294 · BZA
Dhd Diemolding Healthcare Div.
Anesthesiology · 77d
Cleared Jun 10, 1991
COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD
K911310 · DXN
Ge Medical Systems Information...
Cardiovascular · 84d
Cleared Jun 10, 1991
LYME IGM MICROASSAY
K911330 · LSR
Diamedix Corp.
Microbiology · 77d