FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
121225–121248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 10, 1991
LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL
K911347 · JCM
Bio-Rad
Hematology · 75d
Cleared Jun 10, 1991
BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH
K911367 · DQO
Baxter Healthcare Corp
Cardiovascular · 74d
Cleared Jun 10, 1991
EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST
K911569 · LLM
Ortho Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Jun 10, 1991
EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST
K911570 · MCD
Ortho Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Jun 10, 1991
EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST
K911571 · MCD
Ortho Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Jun 10, 1991
DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL
K911854 · JJY
Baxter Healthcare Corp
Chemistry · 45d
Cleared Jun 10, 1991
OSTEOMED IB DRILL
K911937 · EFB
Osteomed Corp.
Dental · 40d
Cleared Jun 10, 1991
IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER
K912016 · JGS
Instrumentation Laboratory CO
Chemistry · 38d
Cleared Jun 10, 1991
SYVA EDMS
K912055 · JJF
Syva Co.
Chemistry · 32d
Cleared Jun 07, 1991
LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS
K904440 · CAZ
Preferred Medical Products
Anesthesiology · 252d
Cleared Jun 07, 1991
NICOLET MAPLELEAF SYSTEM
K905632 · GWJ
Nicolet Instrument Corp.
Neurology · 172d
Cleared Jun 07, 1991
HYDROXYAPATITE COATED PROFILE(R) HIP STEM
K910156 · MEH
Depuy, Inc.
Orthopedic · 144d
Cleared Jun 07, 1991
VISTA HPQ SYSTEM
K910715 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 107d
Cleared Jun 07, 1991
503 PULSE OXIMETER
K911124 · DQA
Criticare Systems, Inc.
Anesthesiology · 87d